Yourlawyer.com (Medtronic Defibrillators Leads News)

Medtronic Cardiac Rhythm Disease Management Site Gets FDA Warning Letter

Thu, 19 Nov 2009 00:00:00 -0800

Device maker giant, Medtronic, Inc., just announced that it received a warning letter from the U.S. Food & Drug Administration (FDA).

According to the Twin Cities Business Journal, the letter came after an inspection of Medtronic’s Mounds View Cardiac Rhythm Disease Management site and concerned: “Corrective and preventative action and field-action timeliness, review and documentation of field action recommendations, supplier qualification and controls, and medical-device reporting timeliness,” said the Business Journal. Medtronic has 15 days to respond to the warning letter.

Medtronic said it will respond to the letter within the mandated timeframe and stated that it is in the process of implementing revised processes in response to the letter, said the Business Journal. Medtronic also said that, according to the FDA’s letter, the agency wrote that the firm’s proposal “appear to be adequate to address the concerns raised in the letter and will be confirmed upon re-inspection,” quoted the Business Journal.

In a statement, Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic said, quoted the Business Journal, “Medtronic remains committed to providing the highest quality products to our customers and is working with FDA to resolve all remaining issues as quickly as possible.”

This is not the first warning letter Medtronic has received in recent months. In June we wrote that Medtronic received a warning letter regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. In the letter, the FDA cited Medtronic for taking too long to recall the SynchroMed pumps. The letter also said that an inspection conducted last year at the Puerto Rican plant where both pumps were made found that Medtronic failed to establish and maintain quality controls in manufacturing. SynchroMed II pumps are implantable devices used to deliver medicine to the spine. The devices have been recalled on several occasions.

According the FDA warning letter, some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with a needed propellant. The problem was not discovered during the manufacturing process even though the pumps went through a propellant weight check, the letter said.

The pumps were recalled for this problem in May 2008, after Medtronic received two reports of SynchroMed pumps being removed from patients because of a lack of propellant. “FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner,” the warning letter, dated June 1, states. “It took almost two years from when the missing propellant was initially identified to conduct a recall.”

The FDA letter also criticized Medtronic for failing to notify the agency within 30 days of at least two reports of potentially serious patient issues with MiniMed Paradigm Insulin Pumps, and for failing to have a person qualified to make a medical judgment determine if reported problems had anything to do with a patient’s death or serious injury. According to the letter, training records indicated that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.

More Claims Filed over Medtronic Sprint Fidelis Leads

Thu, 05 Nov 2009 00:00:00 -0800

Three more lawsuits have been filed against Medtronic, Medtronic USA, Medtronic International Technology, and Medtronic Puerto Rico Operations, reports the Madison Record. The three individuals, residents of Illinois, allege in their 60-count suit, that they suffer sudden shocks after being implanted with defective defibrillators made by the device maker, according to the Madison Record.

The complaints state that Lillian Tengstrand, Effie Thomas, and Marcus Williams received the implantable cardiac defibrillators (ICDs), which are surgically placed under the skin of the chest wall to decrease and increase heart rates, explained the Madison Record. Lead wires are placed into a major vein and attached to interior heart muscle. "Electrodes that sense the heart's rhythm are built into the lead wires and positioned in the heart, where they monitor the heartbeat and can transmit an electric shock to abort a dangerous 'overdrive pace,' a very rapid rhythm, or pace the heart at a normal rhythm if an irregularity is detected," the suit states, quoted the Madison Record.

If a lead breaks, the ICD can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent an ICD from sending a necessary, lifesaving shock to the heart. The Sprint Fidelis lead was removed from the market in October 2007 following reports of five deaths due to lead fractures. Medtronic sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.

Replacing a lead is dangerous and the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture. A choice with which many patients are uncomfortable. According to a report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices.

"Any failure that compromises the ability of the lead to conduct electrical signals will result in a failure of the ICD to perform properly," the suit states. "Lead failures may include fractured wires, bending, insulation loss, loss of ability to capture changes in electrical characteristics in the ventricle chamber, abnormal lead impedance, sensing failure, and changes in tissue conductor interface," it added, quoted the Madison Record.

The plaintiffs were implanted with the Sprint Fidelis Lead Model Number 6949, allegedly defective due to “spot welding” to connect ICD cables to electrodes placed on the heart, say the three, reported the Madison Record. "The welding required to affix the Sprint Fidelis Lead cables can damage the fine, small wires in the cables," the complaint says. "The welding techniques used were inadequate and resulted in damage to the cables in many Sprint Fidelis Leads," reported the Madison Record, citing the complaint.

Although physicians did tell the device maker about the problems, Medtronic apparently disregarded the complaints and initiated a massive, $100 million ad campaign for its ICD products, said the plaintiffs. Medtronic claimed surgical technique, not faulty device leads, were to blame. Defective devices continued to be implanted until Medtronic finally issued a recall following what the plaintiffs described as ICDs failing at “an alarming rate” worldwide, according to the Madison Record.

Grassley Putting More Heat on Spine Surgeon with Medtronic Ties

Wed, 23 Sep 2009 00:00:00 -0700

Senator Charles Grassley (R-Iowa) has expanded his investigation of Dr. David Polly. As we've reported previously, the relationship between Dr. Polly, head of spine surgery at the University of Minnesota, and Medtronic Inc. has been under scrutiny.

Grassley's probe of Dr. Polly has already revealed that he had been paid $1.2 million by Medtronic between 2003 and 2007 for consulting work. Dr. Polly had come under fire in July for not disclosing his relationship with Medtronic when he testified before a Senate committee in 2006 urging more funding for research into combat-related injuries. According to Minneapolis-St. Paul Business Journal, Dr. Polly never told the panel that he was a Medtronic consultant, and was billing the company $6,000 for his appearance.

In July, Grassley sent Medtronic a letter, asking if its payments to Dr. Polly represent a conflict of interest. Grassley also charged in the letter that Dr. Polly gave Medtronic updates on government-sponsored research in violation of an agreement with the university and may have provided inaccurate information to a university ethics committee. Medtronic has said it was not aware that Dr. Polly had failed to tell the Senate committee about his financial ties to the company when he testified. Both the University of Minnesota and Medtronic have launched investigations of the allegations in Grassley’s letter.

Following his May 2006 testimony, Dr. Polly and his colleagues at the University of Minnesota received a $466,644 Department of Defense grant for a two-year study involving Infuse Bone Graft, a Medtronic product. At the time, because of his relationship with Medtronic, the University asked Dr. Polly if an alternate non-Medtronic product could be used in the research. According to the Pioneer Press, documents obtained by Grassley indicated that Dr. Polly told the University that Infuse "the only commercially available off shelf growth factor to date,"

Now the Pioneer Press is reporting that Grassley has written to the University of Minnesota raising issues of possible conflict of interest regarding Dr. Polly's Infuse research. He is questioning Dr. Polly's earlier assertion that Infuse was the only product suitable for his research. The letter says Michigan-based Stryker Corp. has provided information that appears to contradict Dr. Polly's claims, and that Stryker was selling a similar product in 2006.

Recently, Dr. Polly has defended his choice of Infuse by stating that the Stryker product as approved under a special "humanitarian device exemption," which limits sales to 4,000 devices per year, the Pioneer Press said. But Grassley is not buying that argument, writing in his letter that the Stryker product "never exceeded sales of 4,000 units in 2006, so that point appears to be irrelevant."

According to the Minneapolis Star-Tribune, Grassley has also sent a separate letter to University President Robert Bruininks, asking him to turn over any communications between the school and Dr. Polly. But the school, citing privacy laws, said it will only do so if Dr. Polly consents.

In addition, the Star-Tribune is reporting that Grassley also sent letters to Mark Eustis, chief executive of Minnesota's Fairview Health Services, and Timothy Healy, head of Team Spine-Minnesota Inc, a distributor of spine surgery products, requesting information regarding their relationship.

Medtronic Advisory Says Some Concerto, Virtuoso Defibrillator Batteries May Deplete Prematurely

Fri, 11 Sep 2009 00:00:00 -0700

Medtronic Inc. has issued an advisory for 6,300 Concerto CRT-D and Virtuoso implantable defibrillators. According to the advisory, the batteries on these devices may be depleted sooner than normal

According to a letter sent to physicians, the devices affected by this advisory will give a 90-day advanced warning if the batteries are nearing depletion. Medtronic maintains that the battery issue does not compromise device functionality or affect therapy delivery. The company said it has received no reports of death or injury attributed to this issue.

The Concerto and Virtuoso devices in the affected subset were manufactured primarily in 2006 and can be traced to a specific subset of low voltage capacitors, Medtronic said. So far, there have been no related confirmed failures in Concerto and Virtuoso devices outside of this subset, including devices that were manufactured during the same time, the letter said.

Medtronic is offering the following recommendations for patients with Virtuoso and Concerto CRT-D devices in the affected subset:

Physicians should continue routine follow-up sessions at least every three months in accordance with product labeling.
Physicians should verify that the Low Battery Voltage Recommended Replacement Time (RRT) alert is programmed to “On-High.” This provides an audible, alternating tone when the device reaches RRT. These devices are shipped with this alert programmed nominally to “On-High.”
Physicians may consider monitoring patients through CareLink. The CareLink home monitor can be used to automatically notify the clinician when the device reaches RRT.

Patients can determine if their device is included in this advisory by visiting http://CVSNList.medtronic.com. Patients will need the serial number of their device, which is available on their Medtronic patient identification card.

Lawsuits Allege Medtronic, Other Firms Illegally Marketed Surgical Ablation Products

Thu, 16 Jul 2009 00:00:00 -0700

Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in Texas. According to The Wall Street Journal, the lawsuits were filed by former employees of the companies.

Allegations of kickbacks by medical device makers are nothing new. For example, in 2007 a New Jersey based federal probe found that some orthopedic device makers made lucrative payments to U.S. physicians between 2002 and 2006 as a way to encourage doctors to favor their products. Stryker Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

The lawsuits detailed by The Wall Street Journal, which were filed in federal court in Houston, are related to an inquiry in Texas by the U.S. Justice Department that was previously disclosed by several of the companies in filings with the Securities and Exchange Commission. They were originally filed in 2007, the Journal said.

According to the Journal, the lawsuits allege that a "fraudulent marketing and inducement campaign" involving kickbacks to doctors and hospitals resulted in excessive charges to the Medicare insurance program. For example, several of the suits allege that Boston Scientific, Medtronic and AtriCure marketed surgical ablation equipment as a treatment for atrial fibrillation even though it was not approved by the Food and Drug Administration to treat that condition.

Those charges were made by a former Boston Scientific salesperson, who the Journal says, claimed to have been fired after complaining about the company's allegedly illegal practices.

All of the companies involved in the lawsuits told The Wall Street Journal that they were cooperating with the probe. Boston Scientific is no longer in the ablation business, the Journal said.

Medtronic Warned on SynchroMed Drug Pumps, MiniMed Insulin Pump Manufacturing

Thu, 25 Jun 2009 00:00:00 -0700

Medtronic Inc. has received a warning letter regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. In the letter, the Food & Administration (FDA), cites Medtronic for taking too long to recall the SynchroMed pumps. The letter also said that an inspection conducted last year at the Puerto Rican plant where both pumps were made found that Medtronic failed to establish and maintain quality controls in manufacturing.

SynchroMed II pumps are implantable devices used to deliver medicine to the spine. They have been recalled on several occasions.

According the FDA warning letter, some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with a needed propellant. The problem was not discovered during the manufacturing process even though the pumps went through a propellant weight check, the letter said.

The pumps were recalled for this problem in May 2008, after Medtronic received two reports of SynchroMed pumps being removed from patients because of a lack of propellant. "FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner," the warning letter, dated June 1, states. "It took almost two years from when the missing propellant was initially identified to conduct a recall."

The FDA letter also criticized Medtronic for failing to notify the agency within 30 days of at least two reports of potentially serious patient issues with MiniMed Paradigm Insulin Pumps, and for failing to have a person qualified to make a medical judgment determine if reported problems had anything to do with a patient's death or serious injury. According to the letter, training records showed that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.

The FDA warning letter stemmed from an inspection of Medtronic's Puerto Rican facility that occurred from November 12, 2008 through December 15, 2008. The company has 15 working days from the date it received the warning letter to respond to the FDA. The FDA letter warned Medtronic that failure to promptly correct violations could result in regulatory action being initiated without further notice.

Medtronic Says Kappa, Sigma Pacemakers May Have Wiring Problems That Could Lead to Device Failures

Tue, 19 May 2009 00:00:00 -0700

Medtronic Inc. is warning that wiring issues with its older-model Kappa and Sigma implantable defibrillators could pose a risk to patients. According to a letter sent to doctors, the pacemakers may fail at a higher-than-expected rate due to separation of wires that connect the electronic circuit to other pacemaker components. Medtronic said it has received reports of two patient deaths where it is possible, but unclear, whether a wire separation issue may have been a factor.

The first - and most recent - separation issue affects an estimated 15,200 active Kappa devices and 6,100 active Sigma devices, manufactured primarily between November 2000 and November 2002. The Medtronic letter said most of these devices were implanted in patients for five years or longer and may be nearing normal elective replacement time.

Medtronic said it has observed 285 Kappa devices and 131 Sigma devices with this failure mechanism. Its modeling predicts failure rates of 1.1% for Kappa devices and 4.8% for Sigma over the remaining lifetime of these pacemakers due to this issue. According to the letter, there is no provocative testing that can predict which specific devices may fail, and no device programming can mitigate this issue if it occurs.

In the same letter, Medtronic updated performance and patient management recommendations of a different subset of Sigma devices with the same possible clinical presentation, previously reported in a November 2005 advisory. The 2005 advisory was related to wire separations caused by a particular cleaning solvent used in manufacturing and is not related to the new Kappa/Sigma wire separation issue. There are currently an estimated 15,600 active implants from this 2005 Sigma device subset, Medtronic said.

According to a report in The Wall Street Journal, the 2005 advisory told doctors that the issue required "watchful waiting". But because the failure rate from this problem is higher than first thought, the company now recommends that replacement be considered for some patients with Kappa or Sigma pacemakers. Medtronic said in its letter that the current risk of failure for the Sigma pacemakers affected by this problem is less than 4% over the lifespan of the devices.

Medtronic said that for most patients, device failure from either of these issues could result in slow heart rhythms that would cause lightheadedness or fainting, but not life-threatening complications. These patients should seek medical attention if they experience these symptoms.

In a small number of patients who do need pacemakers to provide life-saving therapy at all times, however, such an event could prove fatal. Medtronic's letter said that in these cases, doctors may want to consider replacing the pacemaker.

Medtronic's letter said these two issues could affect a total of 37,000 Kappa and Sigma pacemakers. The company has posted a tool on its website for checking pacemaker serial numbers to determine whether a particular device could potentially have issues.

Defibrillator Leads Need Monitoring, Doctor Group Says

Thu, 14 May 2009 00:00:00 -0700

Defibrillator lead wires, such a those involved in the 2007 Medtronic Sprint Fidelis lead recall, need better surveillance to detect defects, a group of heart doctors has said. The Heart Rhythm Society also called on hospitals to train doctors in the delicate procedure of removing such wires from patients.

A lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.

Medtronic Inc.'s Sprint Fidelis lead was removed from the market in October 2007, following reports of 5 deaths due to lead fractures. As we reported in March, Medtronic recently sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued. According to The New York Times, around 150,000 people are still implanted with a Sprint Fidelis lead.

Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture.

The Heart Rhythm Society, meeting in Boston this week, pointed to the Sprint Fidelis recall in its call for a surveillance system to track lead performance in order to spot defective devices earlier. According to Reuters.com, the group's new policy guidelines cover pre-market evaluation and post-market monitoring of the devices, the threshold for action and communication after abnormal lead performance is identified.

According to the Associated Press, the group also said hospitals need to train more doctors to remove faulty defibrillator leads. They said physicians should perform at least 40 extractions under expert supervision before operating on their own. Supervising physicians should have performed at least 75 extractions with a high rate of success, the group states. They also recommended that such training take place only medical centers that perform a large number of lead extractions each year should train physicians to perform the surgery.

The Heart Rhythm Society also called for tracking the success and failure rates of removal procedures in a national database to give physicians a clearer picture of best practices for the difficult procedures, the Associated Press said.

Finally, the Associated Press said the group called on the Food & Drug Administration (FDA) to require that new defibrillator leads be tested in humans before they are approved. Currently, most leads are approved through the agency's fast track process, which is reserved for devices that are considered modifications of existing products. The fast track process does not require human studies.

Medtronic Sprint Fidelis Leads: Doctors, Patients Face Tough Choices

Wed, 08 Apr 2009 00:00:00 -0700

The procedure to remove one of Medtronic Inc.'s defective Sprint Fidelis defibrillator leads is dangerous and complicated. According to a report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices.

A lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.

The Sprint Fidelis lead was removed from the market in October 2007, following reports of 5 deaths due to lead fractures. As we reported last month, Medtronic recently sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued. According to The New York Times, around 150,000 people are still implanted with a Sprint Fidelis lead.

Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture.

But some patients and doctors are uncomfortable with that advice, The New York Times said. Some surgeons are choosing to take out the leads pre-emptively in patients who depend on their defibrillators to stay alive. Others have begun removing the leads when a patient needs a new defibrillator.

Regardless of when it is done, removing a Sprint Fidelis lead is a risky procedure. One doctor told The New York Times that the four patients who died having a lead removed could just be "the tip of the iceberg." A lead should be removed by a skilled surgeon, and at a medical center were many such procedures have been performed, the Times said.

That's also the guidance Medtronic has given to patients who need to have a Sprint Fidelis extracted. But according to the Times, while the company recently supplied the Food & Drug Administration with a list of 10 medical centers that have experience with lead removals, it has so far declined to make the list public.

In addition to being difficult, the procedure to extract a Sprint Fidelis lead is expensive. The operation alone can cost as much as $20,000 dollars, the Times said. But so far, Medtronic has only agreed to cover the cost of replacement wires.

Unfortunately, the Sprint Fidelis problem is only going to get worse. According to The New York Times, Medtronic expects that thousands of people will need to have Sprint Fidelis leads replaced over the next several years.

Faulty Home Wiring Can Trigger Defibrillator

Fri, 27 Mar 2009 00:00:00 -0700

We’ve long been writing about the problems with lead wires and implanted defibrillators, but now, a surprising situation is emerging out of Denmark, HealthDay News reports, citing a New England Journal of Medicine report.

"We recently cared for a patient who, after receiving an implantable cardioverter defibrillator, was readmitted shortly after hospital discharge because of two shocks delivered while the patient was showering," said the March 26 article, reported HealthDay. There was no clear reason for the device to have activated; however, according to the report, a review "raised suspicion that electrical noise had caused an inappropriate ICD discharge." The Danish doctors had an electrician analyze the home’s electrical wiring, said HealthDay.

Implanted defibrillators deliver a shock to return an arrhythmic heart back to normal rhythm. In this case, there was no precipitating arrhythmia, or irregular heartbeat, to provoke the device from engaging.

"It was found that it was due to improper installation of wiring in the patient's home because he installed a washing machine himself," said Dr. Kristian Eskesen, a cardiologist at Gentofte Hospital in Hellerup and a report co-author, said HealthDay. "It was not properly grounded," Dr. Eskesen explained. According to Dr. Eskesen, had a licensed electrician installed the machine, the shock likely would not have occurred, said HealthDay. In Denmark, safe grounding is legally mandated.

The report from Denmark is not the first of its kind, said HealthDay, in Hong Kong in 2002, a cardiologist reported one case prompted by signals from a power drill and another from a washing machine; in Germany, a similar case originated from a washing machine’s signals, reported HealthDay. "The reason for writing our report was to make colleagues aware of this possible problem," said report co-author Dr. Soren Hjortshoj, of Aalborg Hospital, in Aalborg, Denmark, adding, "… physicians should be aware of the possibility of false shocks and the reason for these," quoted HealthDay.

Meanwhile, Medtronic’s Sprint Fidelis defibrillator leads have been implicated in at least 13 deaths and could be linked to scores of others; up from the five fatalities Medtronic reported when the Sprint Fidelis leads were first removed from the market in 2007.

A lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock or worse, a fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure and surgery can cause the tissue of the blood vessels and heart to tear. In a letter sent to doctors, Medtronic said that the faulty wires were a “possible or likely contributing factor” to the 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients. The company also said in the letter that it has received a total 107 reports claiming that the Sprint Fidelis lead “may have caused or contributed to a patient death.” An independent doctor panel is currently reviewing 89 of those claims, the Medtronic letter said.

According to an earlier Wall Street Journal report, it is estimated that about 150,000 Sprint Fidelis leads remain implanted in U.S. patients.

Medtronic Letter Links Sprint Fidelis Leads to 13 Deaths, Possibly More

Mon, 16 Mar 2009 00:00:00 -0700

Medtronic's Sprint Fidelis defibrillator leads have been implicated in at least 13 deaths and could be linked to scores of others. That's up from the five fatalities Medtronic reported when the Sprint Fidelis leads were first removed from the market in 2007.

A lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture.

In a letter sent to doctors, Medtronic said that the faulty wires were a "possible or likely contributing factor" to the 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.

The company also said in the letter that it has received a total 107 reports claiming that the Sprint Fidelis lead "may have caused or contributed to a patient death." An independent doctor panel is currently reviewing 89 of those claims, the Medtronic letter said.

Medtronic suspended sales of its Sprint Fidelis leads in October 2007, after receiving reports of 5 fatalities linked to lead fractures. Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued.

Not surprisingly, the Sprint Fidelis defects spawned scores of personal injury lawsuits. Unfortunately, the future of those lawsuits was placed in doubt last month when a federal judge in Minneapolis dismissed hundreds of them. In dismissing the claims, the judge cited a Supreme Court ruling issued last year that barred personal injury lawsuits against device makers when a device has been approved by the Food & Drug Administration.

Medtronic's Sprint Fidelis death update is just the latest disturbing news regarding this dangerous defibrillator wires. As we reported last month, a group of researchers from the Minneapolis Heart Institute had also concluded that the risk of a Sprint Fidelis lead fracturing increases as it ages. Their study, published in the journal HeartRythm, saw a Sprint Fidelis failure rate of 3.75% a year, compared with 0.58% among other models. At three years after implant, 87.9% of the Sprint Fidelis leads were working, compared with 98.5% for other models studied.

This means that the Sprint Fidelis lead is still putting thousands of patients at risk. According to The Wall Street Journal, it is estimated that about 150,000 Sprint Fidelis leads remain implanted in U.S. patients.

Medtronic Sprint Fidelis Risk Grows Over Time

Tue, 24 Feb 2009 00:00:00 -0800

A new study has found that Medtronic's Sprint Fidelis defibrillator leads are still putting patients at risk. The Sprint Fidelis leads were removed from the market in October 2007 because of their higher-than-normal fracture rate.

A lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture.

Medtronic suspended sales of its Sprint Fidelis leads in October 2007, after receiving reports of 5 fatalities linked to lead fractures. Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued.

According to a report in The Wall Street Journal, the researchers who first spotted problems with Sprint Fidelis leads have found that the risk of a fracture increases as the device ages. According to cardiologists at the Minneapolis Heart Institute, out of 3,037 patients implanted with defibrillator leads of varying models, a total of 94 leads failed. Seventy-two of the failures were Sprint Fidelis leads, out of 848 Sprint Fidelis leads implanted, The Wall Street Journal said.

The study, published in the journal HeartRythm, saw a Sprint Fidelis failure rate of 3.75% a year, compared with 0.58% among other models. At three years after implant, 87.9% of the Sprint Fidelis leads were working, compared with 98.5% for other models studied.

"The hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable,” the study authors wrote.

These findings mean that the Sprint Fidelis lead is still putting thousands of patients at risk. According to The Wall Street Journal, it is estimated that about 150,000 Sprint Fidelis leads remain implanted in U.S. patients.

Not surprisingly, the Sprint Fidelis defects spawned scores of personal injury lawsuits. Unfortunately, as we reported earlier this month, the future of those lawsuits was placed in doubt when a federal judge in Minneapolis dismissed hundreds of them. In dismissing the claims, the judge cited a Supreme Court ruling issued last year that barred personal injury lawsuits against device makers when a device has been approved by the Food & Drug Administration.

Judge Who Dismissed Sprint Fidelis Lawsuits Linked to Medtronic Law Firm

Fri, 13 Feb 2009 00:00:00 -0800

A judge who recently dismissed hundreds of Medtronic Sprint Fidelis defibrillator lead injury lawsuits apparently has a personal connection to the device maker. According to The Wall Street Journal, the son of Judge Richard H. Kyle of the federal district court in Minneapolis is employed by a law firm that has had Medtronic as a client for quite a while.

Medtronic suspended sales of its Sprint Fidelis Leads in October 2007, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads were told to leave the defective components in place unless they fracture.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued. Not surprisingly, the Sprint Fidelis recall spawned scores of personal injury lawsuits.

Last month, Judge Kyle dismissed hundreds of Sprint Fidelis lawsuits that had been consolidated in federal court in Minneapolis. The judge based his decision on a recent U.S. Supreme Court ruling called Riegel vs. Medtronic (which did not involve the Sprint Fidelis lead) that said the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. The judge wrote that “the court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight. But plaintiffs assert claims for which the court simply cannot provide a remedy.” In the decision, the judge said that it was up to Congress to change the law that bars such lawsuits.

According to The Wall Street Journal, Judge Kyle said lawyers for Sprint Fidelis plaintiffs raised the issue of his son's relationship with Medtronic in a conference call Thursday. Judge Kyle told the Journal that during the call, plaintiffs' lawyers told him they plan to seek his disqualification from the litigation.

Judge Kyle said in the Journal interview that he does not believe his son's connection to Medtronic poses a conflict for him. For its part, that law firm, Fredrikson & Byron, said in a statement that it does represent Medtronic in the Sprint Fidelis litigation.

One legal expert interviewed by the Journal said plaintiffs' lawyers could win such a disqualification if they meet a "tough test that a Medtronic loss would have a substantially negative effect on the son's firm." In that case, the expert said, the cases Judge Kyle dismissed could be reinstated and sent to a new judge.

Medtronic Sprint Fidelis Victims Look to Congress for Help

Mon, 09 Feb 2009 00:00:00 -0800

Lawsuits filed by victims of the defective Medtronic Sprint Fidelis lead are in legal limbo. Thanks to a ruling last year by the U.S. Supreme Court, it is unclear if they will be able to sue Medtronic for painful injuries caused by the Sprint Fidelis defibrillator lead. According to an article in the Minneapolis Star Tribune, the best hope for the victims of this faulty lead is a law passed by Congress to reverse the Supreme Court's decision.

Medtronic suspended sales of its Sprint Fidelis Leads in October 2007, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads were told to leave the defective components in place unless they fracture.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued. Not surprisingly, the Sprint Fidelis recall spawned scores of personal injury lawsuits.

Last February, the Supreme Court ruled in a case called Riegel vs. Medtronic (which did not involve the Sprint Fidelis lead) that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims.

Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws. Eight members of the high court agreed with Medtronic. The Court recently heard another case, Wyeth vs. Levine, that could extend a similar lawsuit shield to drug makers.

Because of the Supreme Court's Riegel decision, a federal judge in U.S. District Court in St. Paul dismissed several hundred cases filed by patients who claim they were injured by the Sprint Fidelis lead. The judge wrote that “the court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight. But plaintiffs assert claims for which the court simply cannot provide a remedy.” In the decision, the judge said that it was up to Congress to change the law that bars such lawsuits.

Some in Congress are seeking to do just that. According to The Minneapolis Star Tribune, Rep. Henry Waxman, D- Calif. and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would ov turn the Supreme Court's Riegel ruling.

The Supreme Court decision "left consumers without any ability to get compensation for injuries caused by certain defective medical devices,'' Waxman said in a statement to the Star Tribune. "The Supreme Court assumed that FDA approval ensures medical devices are safe, but the many recent stories of patients harmed by faulty devices have proven that assumption false."

According to the Star Tribune, the Supreme Court ruling covers Class III medical devices, such as implantable defibrillators, which are theoretically subject to the greatest level of scrutiny by the FDA before they are approved. But lawyers representing Sprint Fidelis victims argue that the lead was not subjected to the same level of clinical scrutiny as other Class III devices because its application piggybacked an earlier Medtronic lead approved by the agency, the Star Tribune said.

Dozens of Medtronic Sprint Fidelis Lawsuits Dismissed

Wed, 07 Jan 2009 00:00:00 -0800

Even while acknowledging that Medtronic Inc.'s defective Sprint Fidelis defibrillator lead caused serious injuries to plaintiffs, a federal judge yesterday dismissed dozens of Sprint Fidelis lawsuits on the grounds of preemption. Preemption is a legal doctrine that federal regulation of a product - such as a medical device - bars lawsuits filed under state law.

Medtronic suspended sales of its Sprint Fidelis Leads in October 2007, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads were told to leave the defective components in place unless they fracture.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued. Not surprisingly, the Sprint Fidelis recall spawned scores of personal injury lawsuits.

Last February, the Supreme Court ruled in a case called Riegel vs. Medtronic (which did not involve the Sprint Fidelis lead) that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims.

Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws. Eight members of the high court agreed with Medtronic. The Court recently heard another case, Wyeth vs. Levine, that could extend a similar lawsuit shield to drug makers.

But the doctrine of preemption is a controversial one, and many believe it puts patients at risk. In an Amicus Brief filed in Wyeth vs. Levin, the editors of the New England Journal of Medicine said the FDA ‘’is in no position'’ to guarantee drug safety, and that product liability lawsuits can serve as ‘’a vital deterrent'’ and protect consumers if drug companies don’t disclose risks.

In a ruling yesterday, U.S. District Judge Richard H. Kyle dismissed dozens of Sprint Fidelis lawsuits. In his decision, the judge wrote that "the court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight. But plaintiffs assert claims for which the court simply cannot provide a remedy."

Judge Kyle also wrote that it was up to Congress to change the law that bars such lawsuits. That is something that could happen. According to The Wall Street Journal, Democrats in both houses of Congress have introduced bills to overturn the Riegel decision. President-elect Barack Obama, who would have to sign such a law once it was passed, was a co-sponsor of the Senate bill.

Doctor Criticizes Test Guidelines for New Defibrillator

Thu, 11 Dec 2008 00:00:00 -0800

Dr. Robert Hauser of the Minneapolis Heart Institute Foundation has said in today’s New England Journal of Medicine that he is not confident in the test guidelines for a next-generation heart defibrillator under development by Medtronic, Inc., Boston Scientific Corporation, and St. Jude Medical, Inc., reports the StarTribune.com.

Implantable cardioverter defibrillators—or ICDs—the device under question, represent a $5 million dollar market, with over 160,000 such devices implanted each year in the U.S., said the StarTribune.com, which explained that the devices are about the size of a stopwatch and work to stop sudden cardiac arrest by shocking the heart back into rhythm. One ICD device runs about $30,000 said TwinCities.com.

The prominent Minneapolis cardiologist questions if the defibrillator will be adequately tested for safety before it is launched in the United States, says the StarTribune.com, which noted that Hauser explained that the new technology could pose deadly risks to patients if it is not scrupulously and thoroughly tested prior to gaining approval. The StarTribune.com, quoted Hauser in the article he wrote in collaboration with the Minneapolis Heart Institute Foundation’s Dr. Adrian Almquist, "The consequences for the patient could be catastrophic."

Hauser is considered somewhat of an industry expert and is a well-known cardiologist in Minneapolis, where the three device makers have a considerable presence, says TwinCities.com. Hauser is asking the three device makers to conduct thorough testing before implementing any changes to implantable cardiac defibrillators, reports TwinCities.com, which also noted that Hauser warned that if the companies do not conduct such testing, there could be "lethal" consequences for patients.

Hauser is best known for his involvement in the Guidant defibrillator recall in 2005 in which he and colleague Dr. Barry Maron exposed safety concerns about a Guidant Corporation (now, under Boston Scientific) defibrillator after one of their patient’s died following implantation with the Guidant device, reported the StarTribune.com. That revelation was followed by a recall involving thousands of defibrillators and pacemakers, and prompted increased review into how “medical device malfunctions are tracked and monitored by the Food and Drug Administration (FDA),” noted the StarTribune.com.

While some argue that testing will occur, Hauser explains that, in a collaboration between the FDA and the three device makers, the new ICD technology, called a “four-pole connector,” will be launched without going through human testing, said TwinCities.com. It seems, notes TwinCities.com, that the emerging technology is only planned for testing in a lab environment and in animals, according to Hauser.

Hauser blames the beleaguered defibrillator market for the push by manufacturers to offer new technology, but argues that, "There is no medically necessary reason for rapidly deploying the four-pole connector. Current connector systems have been in use for more than a decade, and are performing reliably," according to TwinCities.com. While Hauser pointed out that the new technology might prove tempting to the medical community and cardiac patients, he strongly stresses that the technology be tested in humans, pointing out that, "Short-circuiting in an ICD connector can be lethal," reported TwinCities.com.

Head Phones Interfere with Implanted Heart Devices

Mon, 10 Nov 2008 00:00:00 -0800

A new study has revealed that some headphones can interfere with implanted heart devices such as pacemakers or defibrillators, when the headphones and the devices are in close proximity, such as when the headphones are in a shirt pocket or when they are draped around the neck. And, the interference can also occur when the headphones are disconnected.

The headphones might even prevent a defibrillator from delivering a lifesaving shock, say the doctors involved in the study. "Headphones contain magnets, and some of these magnets are powerful," said the study's leader, Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston, Massachusetts. Dr. Maisel is also a heart device consultant to the federal Food and Drug Administration (FDA). "It's smart to keep small electronics at least a few inches from implanted medical devices, and not let someone wearing headphones lean against your chest if you have one,” he said. "The headphone interaction applies whether or not the headphones are plugged in to the music player and whether or not the music player is on or off," Dr. Maisel noted.

Dr. Maisel's research was presented over this past weekend at an American Heart Association conference. The study noted that, globally, nearly two million people have been implanted with pacemakers, defibrillators, or other cardiac devices to enable their hearts to beat faster, slower, or with more regularity.

The FDA conducted tests earlier this year and found that iPods and other such music players tested posed no threat to the cardiac devices as long as they were used properly. Maisel and other doctors were curious to learn if this also applied to headphones and tested eight models—earbuds and those headphones that hook over the ear—in 60 people who were implanted with heart devices. What they found was that when headphones were placed approximately one inch away from the cardiac device, interference was detected in nearly one-quarter of all cases, in four of the 27 pacemaker patients, and also in 10 of the 33 patients implanted with defibrillators. In one case involved in the study, a patient’s pacemaker reset itself

Patients experiencing such interference might not feel anything, or they may experience heart palpitations; however, the interference could temporarily deactivate a defibrillator, which could prevent it from delivering a lifesaving shock when needed. The magnet's effect decreases rapidly when it reaches distance from the device, and the heart device function returns to normal as soon as the headphone is out of range.

The study did not test larger or noise-canceling headphones, but did note that the size of the headphone did not always correlate to its magnetic strength; small, portable devices generally use neodymium, one of the most powerful and concentrated magnetic substances, Maisel said. Dr. Kenneth Ellenbogen, a heart device expert at Virginia Commonwealth University and a spokesman for the heart association, said the solution is simple: "Keep your headphones on your ears and when they're not on your ears, you shouldn't put them over your chest or your pacemaker."

Almost a Year After Sprint Fidelis Recall, Medtronic Unveils Technology to Detect Defibrillator Lead Fractures

Fri, 05 Sep 2008 00:00:00 -0700

Medtronic has received approval from federal regulators for a software update to its implantable defibrillators that will help detect fractures (breaks) in their lead wires. The Food & Drug Administration (FDA) approval of the software update comes nearly one year after Medtronic recalled its Sprint Fidelis defibrillator lead wires because of their high fracture rate.

A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear.

Medtronic suspended sales of the Sprint Fidelis Leads last October after receiving reports of 5 fatalities linked to lead fractures. The Sprint Fidelis had been fracturing at a rate of 2.3% over a 30-month period, more than twice that of an older Medtronic lead, called the Sprint Quattro.

By the time Medtronic issued the recall, the lead had green implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide. The FDA says most of the patients with the Sprint Fidelis lead still have the device implanted because of the danger associated with removal, and are being monitored by their health-care providers for potential fracture.

Medtronic's new software feature, called the Lead Integrity Alert, issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, said in a press release. “While the software doesn't fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”

The FDA press release said that Medtronic has agreed to actively monitor the performance of the new software feature in actual use, which will allow both the company and the agency to ensure that the device is protecting patients as intended.

Defibrillator Shock Linked to Early Death

Thu, 04 Sep 2008 00:00:00 -0700

While a defibrillator shock may provide a lifesaving nudge, the Associated Press reports that such a shock from an implanted heart defibrillator may also be linked to future problems and early death. The government-funded study revealed that heart failure patients were far more likely to die within four years following defibrillator activity than patients who were not shocked.

Experts urge patients to immediately advise their doctors if they experience defibrillator triggering. Likewise, doctors are urged to review their patients' condition to determine if the condition has worsened and if tests or medication changes are required. "We need to think about everything else we possibly could do to make them as healthy as they can be," said the study's lead author, Dr. Jeanne Poole of the University of Washington. The study’s findings appear in today's New England Journal of Medicine.

Approximately 234,800 North Americans have been implanted with defibrillators at a cost of about $25,000-$35,000 each. Defibrillators are about the “size of a stopwatch and designed to correct dangerously high or erratic heartbeats in the lower, pumping chambers of the heart,” said the AP. Earlier research determined that defibrillators cut the risk of death by nearly one-quarter. This new study is derived from that same study of 2,500 heart failure patient. In those earlier cases, patients’ weakened hearts were not pumping efficiently, but patients had not yet experienced a life-threatening irregular heartbeat. This means that although the risk of death was cut by nearly 25 percent, the patients studied did not receive a defibrillator shock.

Although the new report indicates that a defibrillator prolongs "survival in patients with heart failure, with relatively little compromise in the quality of life," wrote Drs. Jeff Healey and Stuart Connolly of McMaster University in Hamilton, Ontario, in a journal editorial, the doctors did add, "It is somewhat disturbing to realize that actually receiving a shock is such an important predictor of death." The study found that approximately one-third of the 811 patients implanted with defibrillators received a shock in about four years of follow-up.

The devices’ recorded data indicates if the shock corrected a life-threatening irregularity or was inappropriately fired by another problem, such as an abnormal rhythm in the heart's upper chambers. The research revealed that patients who needed a shock were five times more likely to die over the next four years than those who didn't require one. Those who did not appear to need a shock but who were shocked, experienced double the risk of dying.

Medtronic Inc. provided the defibrillators used in the research and Wyeth provided the medicine. Many of the researchers and the editorial writers received lecture fees or grants from defibrillator makers. Medtronic defibrillators have been involved in a recalls for problems with faulty leads that could fracture within a patient’s blood vessel, delivering a massive electrical jolt that could result in extreme pain or even death, including at least five such deaths. Problems with Medtronic devices were linked to at least four deaths and one injury because of the devices not charging properly, resulting in late or no delivery of cardiac shock therapy.

Medtronic Sprint Fidelis Lead Victim Asks Lawmakers to Restore Consumers Rights

Thu, 12 Jun 2008 00:00:00 -0700

A Pennsylvania woman went to Capitol Hill yesterday to ask lawmakers to overturn a Supreme Court ruling that has stripped consumers of their right to sue for injuries caused by defective medical devices. Bridget Robb was shocked more than two dozen times due to a defective Sprint Fidelis Lead attached to a Medtronic implantable defibrillator. Because the Supreme Court has taken away her right to sue the company, Robb said she was forced to go to Congress for justice.

Drug makers and medical device manufacturers have been waging an aggressive campaign in the courts to obtain protection against product liability suits. In February, medical device makers got their wish when the Supreme Court ruled that that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. Medtronic, which had brought the case before the Supreme Court, and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

The Bush Administration recently sided with drugmakers in another preemption case involving a Wyeth drug that is going before the High Court in the fall. There is little reason to suspect that the court will act differently towards pharmaceutical companies.

The only way consumers will preserve their rights to sue over defective drugs and medical devices is if Congress passes a law restoring those rights. Yesterday, several victims of faulty devices appeared on before a Congressional committee yesterday, asking lawmakers to do just that.

One of them was 34-year-old Bridget Robb. Robb told lawmakers that she was shocked 31 times in 13 minutes by a recalled Medtronic Sprint Fidelis defibrillator lead. The Sprint Fidelis lead was recalled by Medtronic last year after it received reports of 5 fatalities linked to lead fractures.

According to Robb, her six-year-old daughter watched in horror as her mother's defibrillator shocked her heart multiple times. Robb said she did not know about the Medtronic Sprint Fidelis recall until she arrived at the Emergency Room, even though the company claims it sent certified letters to all patients who received the devices.

Despite her pain and suffering, Robb and thousands of others injured by defective medical devices cannot get compensation for injuries because of the Supreme Court ruling. Hopefully, lawmakers will be moved by these stories and take action to restore the legal rights of all consumers.

Pacemakers Vulnerable to Hackers, Researchers Say

Thu, 29 May 2008 00:00:00 -0700

Pacemakers can be hacked - relatively easily. Now a research team that was able to hack the implantable defibrillators that keep sick hearts beating steadily are telling federal regulators that the problem needs to be addressed.

In recent years, over 100,000 patients in the US have been implanted with a defibrillator device - or pacemaker - that has helped to reduce medical visits. The device and its technology enable patient information to be sent to a bedside monitor that then sends the data to a doctor. Transmissions generally occur once daily. But researchers at the University of Massachusetts Amherst and the University of Washington have discovered that the defibrillator monitoring technology is vulnerable to hacking and—worse—reprogramming that could stop the defibrillators from providing a lifesaving shock.

The Medical Device Security Center, a collaboration of researchers from three universities, tinkered with one on a lab table, after buying $30,000 worth of commercially available equipment to assist the hacking. Researchers ran tests that deduced how a particular defibrillator worked. They used that information to alter it from less than an inch away. Potentially, they said, an attacker could disrupt heartbeats, dangerously drain a battery or even extract private medical information. Their findings were presented May 19 in Oakland, Calif., at a symposium on security and privacy being put on by IEEE, a technology association.

There have been no reports of pacemakers being hacked. But Dr. William Maisel, a Harvard cardiologist who worked with the Center, says the time to take action is now. "This is not an important risk for patients right now," said Dr. Maisel said, "We just want the industry to be thoughtful about where we as a society are going with these devices."

Last month the group discussed its findings with the Food & Drug Administration and a trade association for implanted devices.

Heart Device Patients Often Unaware of Recalls

Fri, 16 May 2008 00:00:00 -0700

It seems that many patients who have been implanted with heart devices are not aware of recent recalls and do not understand the dangers they might face, this according to two new surveys. Although the surveys are small, they do indicate a lack of understanding among doctors and patients about heart disease and the devices used to treat it, said Dr. Bruce Wilkoff, director of cardiac and tachyarrhythmia devices at Cleveland Clinic Wilkoff, who is familiar with the surveys. "There are fundamental problems with even the physician's understanding of the situation and an appropriate focus on accurate information," Wilkoff added. One of the new surveys found that nearly one in five heart patients didn't know about recent recalls of their devices.

Meanwhile, recent recalls of implanted defibrillators have forced some patients to have them removed. Spefically, defibrillator lead wires—especially those in the Medtronic Sprint Fidelis and St. Jude Riata devices—have fractured, perforated patient heart walls, or caused device failure. In some, these malfunctions led to additional cardiac procedures or complications and even death. Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator. When a defibrillator wire detaches or breaks, the device will fail leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made its way through the heart wall.

The findings are planned to be released at the Heart Rhythm Society's annual meeting in San Francisco and involved 61 randomly selected patients at the University of Maryland and the Baltimore VA Medical Center who were asked about recalls between October 2006 and April 2007. Eighteen percent didn't know about any pacemaker or defibrillator recall, about half learned about recalls through the media, 24 percent heard through their doctor, and over half said they'd be very worried if their device was recalled.

"We need to do a little better of a job and find better means of talking to our patients," said survey lead author Dr. Timm-Michael Dickfeld, director of electrophysiology at the Baltimore VA Medical Center. "They seem to like to have the physicians talk to them more, and explain these things more, and not leave it up to the media or the TV to inform them."

A second survey, conducted by doctors at the University of Oklahoma, asked 165 patients with a variety of heart devices whether they'd want them removed if there was a recall or safety advisory. Five percent reported they'd want the device removed immediately if there was a "recall" and 2.5 percent said they'd want it taken out if there was a "safety advisory."

Medtronic Announces Job Cuts, Restructuring

Wed, 07 May 2008 00:00:00 -0700

Still struggling in the wake of last year's Sprint Fidelis Defibrillator Lead recall, medical device maker Medtronic Inc. says it plans to cut 1,100 jobs worldwide as part of a restructuring plan. Medtronic's business has been hurt, not just by the Sprint Fidelis recall, but by the declining worldwide demand for implantable defibrillators, which has been shrinking since Medtronic and competitors recalled faulty products in 2005.

Medtronic suspended sales of the Sprint Fidelis Leads in October 2007 after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

Last November, Medtronic said the Sprint Fidelis recall hurt revenue in its Cardiac Rhythm Disease Management unit by $130 million, and it also absorbed $31 million in costs to write off the Sprint Fidelis leads recalled during the quarter in which the recall occurred. Medtronic's revenue grew 12 percent in its most recent quarter, though revenue in the cardiac rhythm disease management unit rose just 3 percent.

According to Reuters, as part of the restructuring effort, Medtronic will move its endovascular manufacturing operations to Galway, Ireland, from Santa Rosa, California. The endovascular division makes stent grafts to treat aortic abdominal aneurysms. It also intends to relocate the diagnostic and monitoring portion of its cardiac rhythm disease management business to Minneapolis from the Netherlands.

This is not the first time Medtronic has been forced to make job cuts. Last year, the company eliminated a total of 900 jobs in its cardiac rhythm management, cardiovascular, and Physio-Control external defibrillator businesses.

Medtronic faces many lawsuits over the defective Sprint Fidelis Lead, as well as some of its other defective medical devices. Last December, the company agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators.

Late last month, Medtronic announced it had reached an agreement with Food and Drug Administration (FDA) over quality system improvements for its external defibrillators. The agreement addressed concerns raised by the FDA during inspections and outlined actions Medtronic’s Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices. Physio-Control stopped U.S. shipments in January 2007 due to quality problems.

Medtronic Unit Agrees to Consent Decree

Mon, 28 Apr 2008 00:00:00 -0700

An agreement has been reached by a unit of Medtronic Inc. on a consent decree with the U.S. Food and Drug Administration (FDA) over quality system improvements for its external defibrillators. The agreement—which is subject to court approval—addresses concerns raised by the FDA during inspections and outlines actions Medtronic's Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices. Physio-control is a maker of external defibrillators,

Automated external defibrillators, or AEDs, are becoming more and more available in office buildings, schools, and other public venues for use by bystanders to help a person suffering from sudden cardiac arrest. Physio-Control stopped U.S. shipments in January 2007 due to quality problems. Medtronic said shipments to meet critical customer requirements and certain specified public health needs will continue; however, in September, Medtronic announced plans to eliminate about 200 jobs in the Physio-Control unit. The consent decree agreement requires court approval.

Meanwhile, last October, Medtronic announced it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators.   According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt.   This malfunction can cause extreme pain, or—in the worse case scenario—death.   At least five deaths were linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

The Sprint Fidelis lead has been used in implantable Medtronic defibrillators since 2004; most patients who received the devices since then have the faulty leads.   Sprint Fidelis leads were used only in cardiac defibrillators—or complex devices with defibrillation capacity—not conventional pacemakers. Some patients with congestive heart failure use devices that included this defibrillation ability, and those were among the machines that use the Sprint Fidelis lead.

A company review of 30 months of data indicated the defibrillator lead had a continuing fracture problem.   According to the company’s own estimates, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of Medtronic defibrillator implantation.   Patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to replace the wire.

Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse. When a defibrillator wire detaches or breaks, the device will fail, leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. Lead fracture can cause the device to beep, alerting the patient to seek immediate medical attention; however, the fracture can also cause a massive electrical shock resulting in extreme and sudden chest pain. Worse, the fracture can deplete the battery, rendering the defibrillator unable to deliver a necessary, life-saving shock to the heart. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made it through the heart wall.

Hacking Latest Safety Worry Surrounding Implantable Defibrillators

Wed, 12 Mar 2008 00:00:00 -0700

A new type of implantable defibrillator could become the latest target of computer hackers. In recent years, over 100,000 patients in the US have been implanted with a defibrillator device that has helped to reduce medical visits. The device and its technology enable patient information to be sent to a bedside monitor that then sends the data to a doctor. Transmissions generally occur once daily. Now, this relatively common defibrillator monitoring technology appears to be vulnerable to hacking and—worse—reprogramming that could stop the defibrillators from providing a lifesaving shock, according to research being released today.

Defibrillator transmissions sent to the bedside monitor are not encrypted, meaning that someone intercepting transmissions could retrieve data such as a patient's birth date, medical ID, and Social Security number. Researchers are concerned that as this technology is used in more devices—pacemakers, spinal cord stimulators, and hearing implants—and as radio ranges increase, patients’ data will be at greater risk. "There will be more implanted devices and more wireless capabilities and transmissions over greater distances," said Dr. William Maisel, a study authors and Harvard-affiliated director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston.

Food and Drug Administration spokeswoman, Peper Long, said hackers could use special software and antennas to intercept defibrillator transmissions, but felt this sort of hacking and malicious reprogramming, was "remote." "The benefits clearly outweigh the risks," said Long.

Defibrillators use electrical shocks to restore a heart to a normal heartbeat when it detects arrhythmia or other abnormalities; the American Heart Association recommends stopped hearts be shocked within two minutes. Chief defibrillator makers are Medtronic Inc., Boston Scientific Corp., and St. Jude Medical Inc. Maisel's team studied Medtronic's Maximo defibrillator.

Bruce Lindsay, an electro physiologist at the Cleveland Clinic and president of the Heart Rhythm Society, said defibrillator transmissions are "not designed to withstand terrorist attacks. But I don't think the findings have any great clinical significance. To hack the system, you have to get the programmer right up against the patient's chest. It's not as if somebody could do this from down the street."

Medtronic spokesman Rob Clark said the risk of any "deliberate, malicious, or unauthorized manipulation of a device is extremely low." Clark said future versions capable of transmitting signals as far as 30 feet will have stronger security. Boston Scientific said its defibrillators "incorporate encryption and security technologies designed to mitigate these risks," including measures to prevent unauthorized reprogramming. St. Jude said, "As the study points out, the likelihood of unauthorized or illegal manipulation of an implantable device is extremely remote, and St. Jude Medical is not aware of such an event with our devices."

Future iterations will have stronger, improved technology. "Our issues are less with the current generation of devices than with where we see the industry going with implanted medical devices," said Maisel. Maisel’s and fellow author Tadayoshi Kohno’s—a University of Washington assistant professor who co-led a 2003 study that raised questions about the security of an electronic voting system—study will be presented and published May 19 at a conference of the Institute of Electrical and Electronic Engineers Symposium on Security and Privacy.

Medtronic, FDA Fell Short in Sprint Fidelis Lead Recall

Thu, 06 Mar 2008 00:00:00 -0800

The Medtronic Sprint Fidelis Lead debacle highlights many of the shortcomings that exist in the way the Food & Drug Administration (FDA) regulates medical devices, according to a recent editorial in the New England Journal of Medicine (NEJM). Medtronic recalled its Sprint Fidelis Lead last October, after it was determined that the lead had a high rate of fracturing.

Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads were told to leave the defective components in place unless they fracture.

The Sprint Fidelis Lead was designed to replace Medtronic’s Sprint Quattro models, and it is one of the thinnest defibrillator lead wires on the market. Since it was put on the market in 2004, Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators. But according to an editorial appearing in the March issue of the NEJM, not only was the Sprint Fidelis Lead never tested in humans, and both Medtronic and the FDA had received reports of problems with the lead long before the October 2007 recall.

When the FDA approved the Medtronic Sprint Fidelis Lead in 2004 , it did so on the basis of bench testing but no human clinical data. That's because the Sprint Fidelis was considered an improvement or modification of the existing Sprint Quatro Lead. In such cases, the FDA requires no testing in humans.

By March 2007, Medtronic had received a disturbing number of reports about the Sprint Fidelis Lead's high fracture rate. According to the NEJM editorial, Medtronic sent physicians a letter informing them that "a limited number" of physicians were seeing a higher-than-expected rate of lead fractures. Medtronic concluded that the lead's performance was "in line with other Medtronic leads" on the basis of two main factors: analysis of returned products and a small prospective postmarketing study that found a 1.1% rate of lead failure within 2 years of implantation. But that postmarketing study included fewer than 100 patients followed for 2 years. According to the editorial, it was "grossly underpowered to detect even a moderate increase in fracture rate in the Fidelis as compared with its predecessors". Medtronic then began collecting and analyzing data from more than 25,000 patients participating in its remote monitoring program.

Then, Medtronic submitted an FDA application for design and manufacturing changes to the Sprint Fidelis Lead in May 2007 and, according to the FDA's public premarket approval database, received approval 2 months later. While it was waiting for the approval, Medtronic was allowed to maintain that the Sprint Fidelis Lead was safe, and the company allowed already-manufactured leads to continue to be implanted. By October 2007, Medtronic had confirmed the occurrence of 665 fractures in returned leads, and a 2.3% fracture rate within 30 months of implantation. It was only then that Medtronic voluntarily recalled the defective Sprint Fidelis Leads.

Medtronic Pushes for Expansion of 'Sunshine Act'

Wed, 27 Feb 2008 00:00:00 -0800

Medical device maker Medtronic Inc. said on Tuesday that a proposed bill aimed at curbing inappropriate relationships between companies and physicians should require all device makers to be included, not just big ones. The proposed "Sunshine Act" was introduced earlier this year by Senators Chuck Grassley and Herb Kohl and would require companies to publicly disclose—via the Internet—certain payments made to physicians for help with product development, research, and training. Currently, the bill excludes companies with an annual revenue of less than $100 million as well as physician-owned companies, which Medtronic claims accounts for 75 percent of the companies in the medical device industry. Medtronic said "a level playing field for all companies is appropriate and that these entities should operate under the same disclosure requirements, recognizing that transparency can help alleviate any real or perceived conflicts of interest with these types of companies as well."

Recently, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this must change. The team also found that once a device receives Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial. According to the team, this data would improve health professionals' awareness of "the potential promise and pitfalls of new technology.”

The analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit. Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the scrutiny required for new drugs. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

The team suggested assessments by objective third parties as well as FDA approval to ensure deficiencies in clinical evidence and patient safety issues that may arise after approval are recognized earlier on. Independent review organizations provide transparent, objective evaluations, such as the California Technology Assessment Forum (CTAF) which conducts open, public meetings. Among others, their review board is comprised of experts in medicine, representatives from medical professional societies, technology manufacturers, policy makers, and insurance providers. The UCSF Division of General Internal Medicine currently subcontracts with CTAF to provide technology assessments. To be considered in an assessment, CTAF requires information be published or accepted by a peer-reviewed journal, encouraging companies to publicize their trial results. “CTAF also requires improvements in patient-oriented outcomes, not surrogate markers….we want to see improvements in disease-free survival and patient quality of life, not just a reduction in tumor size," said Tice, attending physician in the Division of General Internal Medicine at UCSF. The authors suggest independent review boards summarize their findings into uncomplicated take-home messages patients can easily locate.

Medtronic Defibrillator Lawsuit Settlements Take a Toll on Profits

Fri, 22 Feb 2008 00:00:00 -0800

Medtronic Inc.'s profits are off sharply, in part because of problems the company has had with its defective implantable defibrillators. Medtronic's third-quarter earnings plunged 89.0% from the prior year on charges from lawsuit settlements stemming from defective defibrillators and acquisition costs.

According to Forbes.com, overall sales at Medtronic jumped 12.0% to $3.4 billion, up from $3.1 billion in the third quarter of 2006, due to strong international sales. But because of lawsuit settlements and other charges, Medtronic's net income for the third quarter fell to of $77.0 million, or 7 cents per share, down from $710 million, or 61 cents per share, in the prior year.

The charges that hit Medtronic's bottom line included $275 million for the settlement of lawsuits stemming from its recalled Marquis line of implantable defibrillators, which treat rapid heart rhythms, and a stent patent infringement case by Cordis, a subsidiary of Johnson & Johnson. The Marquis settlement dates back to February 2005, when Medtronic warned of a potential battery shorting problem in various Marquis-brand defibrillators. According to the Wall Street Journal, 11,000 of the machines were surgically removed and replaced with a different device in the U.S. and 2,000 more such removals took place overseas. The Food & Drug Administration (FDA) classified Medtronic’s action as a Class II recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but sold its stock of potentially defective devices and didn’t advise patients that safer devices were available. The company had argued that it fulfilled every obligation in terms of reporting the problem, including seeking and receiving FDA approval in 2003 to implement battery design changes. But despite its claims that it acted properly, Medtronic settled thousands of defective Marquis Defibrillator lawsuits in December.

Medtronic has long been plagued by safety problems surrounding its ICDs and other devices. In April 2004 Medtronic announced that it was recalling its Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 ICDs after they had been linked to at least four deaths and one injury. Medtronic said at the time that some of the recalled defibrillators failed to charge properly, resulting in the late delivery or no delivery of cardiac shock therapy. In January 2007 the FDA announced that the agency started an investigation looking into accusations by a former Medtronic engineer that the medical-device company didn’t sufficiently test its new Concerto cardiac device for patients with congestive heart failure. The Concerto device is one that can resynchronize the heartbeat of a patient and also provide backup defibrillator capability to save the patient’s life if the heart goes into cardiac arrest.

In October 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal. At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

Medical Device Makers Get Lawsuit Protection from US Supreme Court

Thu, 21 Feb 2008 00:00:00 -0800

Medtronic Inc. and other medical device makers got a gift from the US Supreme Court yesterday, after it ruled that Food & Drug Administration (FDA) pre-market approval of a medical device shields companies from state product liability lawsuits. While the Supreme Court ruling will nullify some medical device product liability lawsuits currently making their way through state courts, it is unclear how great an affect it will really have, because most medical devices on the market today went through a different approval process than the one at issue in this case.

According to The New York Times, the Supreme Court's decision was one sought by the Bush Administration, which since 2004 has been trying to reverse longstanding federal policy that “premarket approval” of a new medical device by the FDA overrides most claims for damages under state law. In the case considered by the Supreme Court, Medtronic had argued that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims. Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

Eight members of the Supreme Court agreed. In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device. Justice Scalia wrote that state tort law amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.

The sole dissenter on the court, Justice Ruth Bader Ginsberg, clearly disagreed. In her dissent, the Justice wrote that court had misread Congress’s intent in adding the pre-emption clause to the law. All Congress intended when it wrote the law was to prevent individual states from imposing their own premarket approval process on new medical devices, Justice Ginsberg argued.

Several lawmakers quickly voiced their disapproval of the Supreme Court's decision and promised quick action to reverse it. “The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” Rep. Henry Waxman (D-Calif) told The New York Times. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

It's not clear how many current state medical device lawsuits might be barred as a result of this ruling, but it does not ban all of them. According to The New York Times, most medical devices now available reached the market through a different process, under which the FDA. found them to be “substantially equivalent” to those marketed before the 1976 law took effect. The Supreme Court ruled in 1996 that this approval process does not pre-empt state damage suits against manufacturers. The decision also does not ban state lawsuits against medical devices that are not manufactured according to FDA specifications, and lawsuits can still be brought under state laws that mirror federal laws.

But the Bush Administration is still not finished with the pre-emption issue. According to The New York Times, next Monday, the Supreme Court will hear another FDA. pre-emption case, Warner-Lambert Co. v. Kent. The issue in that case is whether a state lawsuit can be based on the claim that a drug maker committed fraud by misrepresenting or withholding information from the FDA during the approval process. The Bush Administration has taken the side of drug makers in that case. The Administration is also arguing in Wyeth vs. Levine - a case the Supreme Court is taking up next term - that, in the case of FDA approved drugs, a shield exists against state product liability lawsuits even though the Food, Drug and Cosmetic Act of 1938 does not contain a pre-emption clause.

Defective Medical Devices Show Need for More Regulation

Fri, 08 Feb 2008 00:00:00 -0800

Defective medical devices like Stryker hip implants, Medtronic Defibrillators and the Kugel Mesh Hernia Patch have injured countless people. Now researchers from the University of California, San Francisco (UCSF) have asserted that medical devices are not subject to the same rigorous review process as pharmaceuticals and this needs to change to improve health outcomes. The team analyzed the problem and proposed solutions in a "Perspectives" article in the January 2008 issue of the Journal of General Internal Medicine. UCSF researchers Mitchell D. Feldman, MD, MPhil, and Jeffrey A. Tice, MD, edited the issue.

The team found once a device receives Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial. According to the team, this data would improve health professionals' awareness of "the potential promise and pitfalls of new technology.” Feldman, professor of medicine at UCSF said, "These days, patients are asking their doctors for the newest technologies from genetic tests to specific radiation treatments and many physicians don't know where to turn for the latest evidence-based information. Sometimes, the only information out there is what the manufacturer provides."

The UCSF analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit. Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the scrutiny required for new drugs. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

"FDA approval should be the start of the process toward clinical application, not the end," Feldman said. "Physicians and patients just aren't aware of the limitations of the FDA process of initial assessment and oversight of new medical technologies. Assessments by objective entities are a necessary addition to FDA approval, so that deficiencies in clinical evidence, and patient safety issues that may arise after approval, are recognized before widespread adoption into clinical practice." The purpose of independent review organizations is to provide transparent, objective evaluations, Feldman said. Some, like the California Technology Assessment Forum (CTAF) conduct open, public meetings. Among others, their review board is filled with experts in medicine, representatives from medical professional societies, technology manufacturers, policy maker,s and insurance providers. The UCSF Division of General Internal Medicine currently subcontracts with CTAF to provide technology assessments.

"In order to be considered in an assessment, CTAF requires that information already be published or accepted by a peer-reviewed journal. This encourages companies to make their trial results available to the public," said Tice, attending physician in the Division of General Internal Medicine at UCSF. "CTAF also requires improvements in patient-oriented outcomes, not surrogate markers. For example, we want to see improvements in disease-free survival and patient quality of life, not just a reduction in tumor size."

Eventually, the authors suggest, independent review boards should summarize their findings into uncomplicated take-home messages that patients can easily find on their own.

Medtronic Sprint Fidelis Lead Caused PTSD, Lawsuit Claims

Thu, 24 Jan 2008 00:00:00 -0800

Medtronic has been sued by a man who says a faulty Sprint Fidelis Defibrillator Lead caused him to suffer from Post Traumatic Stress Syndrome (PTSD). Donald LarryJackson claims the unexpected shocks he received from an implantable cardiac defibrillator (ICD) constitute civil battery and caused such severe anxiety he now suffers from PTSD and requires psychiatric care.

A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the ICD. When a wire detaches or breaks, the device fails, leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. Medtronic stopped selling Sprint Fidelis Leads in October 2007 due to a high fracture rate. Fractures of Sprint Fidelis Leads have been implicated in the deaths of five people. It is believed the thin design of Medtronic’s Sprint Fidelis lead wires malfunction due to too-thin diameter models. The Sprint Fidelis Leads’ fracture rate is considered significant.

The Food and Drug Administration (FDA) is investigating the link between defibrillator lead wire diameter and safety and performance issues. The FDA states, "When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or 'fractures,' the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered."

Although experts do not advise patients replace leads due to removal risks, which exceed lead failure risk, Jackson underwent emergency surgery to replace the ICD; he continues to suffer heart palpitations, anxiety, and claims to be at increased risk of cardiovascular events or death. Jackson is seeking punitive, exemplary, and compensatory damages, a declaratory judgment, restitution of disgorgement of profits, attorney fees, prejudgment interest, and other equitable relief as requested and is seeking claims of relief for products liability, breach of implied warranty, negligence, intentional infliction of emotional distress, negligent infliction of emotional distress, violation of consumer protection statutes, breach of express warranties, unjust enrichment, battery, and negligent misrepresentation.

Although Medtronic maintains it is advising individual patients, Jackson claims he was not given notice of the increased fracturing risk.

Medtronic Supreme Court Case Could Have Dire Consequences for Consumers Injured by Defective Medical Devices

Thu, 03 Jan 2008 00:00:00 -0800

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, has asked the US Supreme Court to shield it and other medical devices makers from state product liability lawsuits. In Reigel vs. Medtronic, the medical device maker argued before the Supreme Court on December 4 that the mere fact that medical devices are approved by the Food & Drug Administration (FDA) preempts patients from bring lawsuits in state courts if they are injured by a defective device. If Medtronic somehow convinces the court to ban such lawsuits, consumers will lose an important protection against defective medical devices.

Medtronic vs. Reigel stems from a lawsuit filed by the family of a New York man who suffered severe medical complications when a Medtronic-made balloon catheter burst during a procedure to clear his arteries. The man’s family sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval. The case was thrown out by a US District Court judge and then by the US Court of Appeals.   The family is now appealing to the US Supreme Court.

Medtronic is arguing that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims. But Medtronic believes that the amendments do just that. Before the Supreme Court, the company argued that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

This is not the first time Medtronic has tried this argument. In a Florida court in 1993, Lora Lohr and her husband had sought damages for an allegedly faulty pacemaker lead manufactured by Medtronic. The company argued that the Medical Device Amendments preempted any damages claims because the device had been approved for marketing by the FDA. In Medtronic vs. Lohr, the Court held that none of the Lohrs' damages claims were preempted by the 1976 law.

In the Reigel lawsuit, Medtronic is trying the preemption argument again, but this time, the FDA is on its side.   During the Lohr lawsuit, the FDA sided with consumers and argued that the 1976 law did not disallow state lawsuits against FDA approved devices.   But now, the agency has reversed itself and is arguing Medtronic’s side. In fact, US Deputy Solicitor General Edwin Kneedler, on behalf of the Bush Administration, argued before the Supreme Court on December 4th in support of Medtronic’s position. The Bush Administration believes that the FDA approval process is adequate to protect consumers from dangerous medical devices. Unfortunately, past experience has not proven this to be true.

The past several years have proven that FDA cannot be trusted to keep consumers safe. In some case, the agency has approved drugs - like Vioxx and the Ortho Evra birth control patch – based on sloppy or falsified test data. In other cases, the FDA testing process completely missed defects. This is what happened with the Medtronic Sprint Fidelis Lead, where its high fracture rate did not become apparent until it had been implanted in tens of thousands of people. In many cases, it is only through litigation that it is discovered that medical manufactures withheld information about defective products from the FDA and the public.

The Supreme Court’s decision in Reigel vs. Medtronic will have serious implications for consumers. If Medtronic is successful, patients injured by defective medical devices will have no recourse in state courts to seek compensation for their injuries.   And manufacturers like Medtronic will not have to fear the financial consequences of unleashing dangerous medical devices on an unprotected public.

Poor FDA Scrutiny of Medtronic Sprint Fidelis Lead, Other Implantable Medical Devices Continues to Endanger Patients

Wed, 02 Jan 2008 00:00:00 -0800

The 2007 Medtronic Sprint Fidelis Defibrillator Lead Recall could just be the tip of the iceberg when it comes to defective implantable medical devices. That’s because the number of medical devices meant to be implanted in patients’ bodies is rapidly rising. Unfortunately, despite their rising numbers, as the case of the Sprint Fidelis Lead recall illustrates, the Food & Drug Administration (FDA) is doing a poor job of regulating implantable devices, and often ignores reports of device failures until someone dies.

Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

Since it was put on the market in 2004, Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide, and about 235,000 people still have these leads in their chests. But in spite of such widespread use, the FDA never required the Sprint Fidelis Leads to be tested in humans before they were marketed, and it did not monitor the device after it was introduced.

Within a couple of years of the Sprint Fidelis Lead’s introduction, emergency rooms around the country began to see patients injured by the fractured device. The problems were disturbing enough that the Minneapolis Heart Institute decided to conduct a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country. The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.

Despite being informed of the Minneapolis Heart Institute’s Sprint Fidelis Lead study, the FDA did nothing. An FDA spokesperson told the Wall Street Journal in October that the agency did not require any post-market surveillance of the Sprint Fidelis Lead because “no issues were raised in the premarket review that suggested the need for a postmarket study.” It wasn’t until 5 patients died that the defective Medtronic Sprint Fidelis Lead was removed from the market.

Because of the FDA’s poor oversight of implantable medical devices, thousands of people with Medtronic Sprint Fidelis Defibrillator Leads must live with the knowledge that the defective component could fail at anytime. In general, this poor FDA oversight means that patients with any type of implantable medical device can’t be sure that they don’t face similar dangers.

Medtronic Settles Defective Defibrillator Lawsuits for $114 Million

Wed, 26 Dec 2007 00:00:00 -0800

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices. The company has agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators. Despite the huge settlement agreement, Medtronic said it does not admit liability in the litigation.

Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous rapid beating. They treat patients at risk for sudden cardiac death, which is the leading natural cause of death in the U.S. In February 2005, Medtronic warned of a potential battery shorting problem in various Marquis-brand defibrillators. According to the Wall Street Journal, 11,000 of the machines were surgically removed and replaced with a different device in the U.S. and 2,000 more such removals took place overseas. The Food & Drug Administration (FDA) classified Medtronic's action as a Class II recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but sold its stock of potentially defective devices and didn't advise patients that safer devices were available. The company has argued that it fulfilled every obligation in terms of reporting the problem, including seeking and receiving FDA approval in 2003 to implement battery design changes. Yet in spite its claims that it acted properly, Medtronic is now settling thousands of defective Marquis Defibrillator Lawsuits. The company will pay a total of $114 million, as it settles 2,682 cases for $95.6 million as well as $18.5 million in attorneys' fee.

Medtronic, the largest manufacturer of ICDs, has had other problems with many of its devices. In April 2004 Medtronic announced that it was recalling its Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 ICDs after they had been linked to at least four deaths and one injury. Medtronic said at the time that some of the recalled defibrillators failed to charge properly, resulting in the late delivery or no delivery of cardiac shock therapy. In January 2007 the FDA announced that the agency started an investigation looking into accusations by a former Medtronic engineer that the medical-device company didn't sufficiently test its new Concerto cardiac device for patients with congestive heart failure. The Concerto device is one that can resynchronize the heartbeat of a patient and also provide backup defibrillator capability to save the patient's life if the heart goes into cardiac arrest.

In October 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal. At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

Sprint Fidelis Defibrillator Lead Patients Faced with Difficult Dilemma

Thu, 13 Dec 2007 00:00:00 -0800

Many patients implanted with defective Medtronic Sprint Fidelis Defibrillator Leads have found themselves in a medical limbo. If they are fortunate enough not to have already experienced a lead fracture, they must decide between two difficult choices – leave the Sprint Fidelis lead alone and hope it won’t fracture; or undergo a difficult and dangerous surgery to have the faulty lead replaced. Both options are bad ones – a fact that has left many Sprint Fidelis Lead patients anxious and confused.

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear.

Lead replacement is also an expensive procedure, and can cost in excess of $12,000. And even though it made the defective Sprint Fidelis Lead that is now causing so many patients so much anxiety, Medtronic is doing little to absorb the costs of lead replacement. When it first announced the Sprint Fidelis Lead recall in October, Medtronic said would cover the cost of a new lead, as well as pay $800 in medical costs for patients whose lead had fractured. But later, the company extended that coverage to patients without fractures, in cases where doctors advise removing the leads because of the patient’s specific medical condition. Even with Medtronic’s contribution, however, patients who have their Sprint Fidelis leads replaced could still be left with a large medical bill. So far insurers are deciding whether to cover the replacement operation on a case-by-case basis, unless the lead has already fractured.

Patients whose doctors don’t recommend the removal of the Sprint Fidelis Lead have little choice to wait and hope it does not fail. Their defibrillators will need to be reprogrammed and monitored, to improve the odds of catching any developing fractures early. But this precaution does not come with a guarantee that all Sprint Fidelis Lead failures will be caught before a patient is injured, and the component could still fracture without warning.

The number of people left to worry that their Sprint Fidelis Lead will one day fracture is staggering. Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide, and about 235,000 people still have these leads in their chests. It will be a long time – if ever – before all of these Sprint Fidelis Lead patients can feel secure.

Medtronic Defibrillator Class Action Lawsuit Gets Go Ahead in Canada

Mon, 10 Dec 2007 00:00:00 -0800

Medtronic Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead Wire, is now facing a lawsuit filed by a group of Canadians who claim the company failed to warn consumers of a defect in the batteries installed in its defibrillators. Last week, Ontario Superior Court Judge Alexandra Hoy certified the class-action lawsuit in a ruling released Dec. 6 in Toronto, allowing the plaintiffs to seek a portion of Medtronic profits for damages.

In Canada, 2,416 patients had the Medtronic defibrillators implanted as of February 2005, with 613 of them having been removed or replaced as of June 2007.

In 2005, Medtronic announced that it was recalling two heart defibrillators because they had been linked to at least four deaths and one injury. These devices are used to shock the heart into normal rhythm after patients suffer irregular heartbeat or fibrillation, which are rapid, life-threatening arrhythmia's, originating in the lower chambers of the heart. The defibrillators are implanted surgically in the chest. When a cardiac arrhythmia occurs, the capacitor is charged and the device delivers the appropriate shock. Medtronic said that some of the recalled defibrillators failed to charge properly, a defect which can result in the late delivery or no delivery of cardiac shock therapy. Medtronic had actually discovered the problem with its defibrillators in 2003, but did not disclose the problems immediately.

In October, Medtronic agreed to pay $130 million to settle U.S. claims it hid the defects in the defibrillators, $55 million more than it proposed in a July settlement, people familiar with the agreement said at the time. The company agreed to the higher amount after more claims were filed over the heart defibrillators than the parties expected, the people said.

But the October settlement was not the end of Medtronic's defibrillator woes. That same month, Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient's heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.

Just last week, lawyers for Medtronic went before the US Supreme Court to ask that people injured by defective medical devices and drugs should not be allowed to sue manufacturers if those products have been approved by the Food & Drug Administration.

Medtronic Faces Investigations over Defective Sprint Fidelis Defibrillator Lead, Physician Payments

Wed, 05 Dec 2007 00:00:00 -0800

Medtronic, Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, is the now the subject of two separate investigations. A Senate panel wants information about Medtronic's October Sprint Fidelis Defibrillator Lead recall, while a second investigation by the US Justice Department is looking into allegations that Medtronic made illegal payments to foreign physicians.

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient's heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Following the recall, it was learned that Medtronic had been receiving reports that indicated the Sprint Fidelis Lead had a higher-than-normal fracture rate for months. The incident has raised questions about the Food & Drug Administration's (FDA) regulation of medical devices, and of the Medtronic's response to early reports of lead problems.

Medtronic has acknowledged in a Securities and Exchange Commission (SEC) filing that the Senate Finance Committee has requested information about ties between the medical-device industry and practicing physicians and information about Medtronic's suspended distribution of its Sprint Fidelis family of defibrillation leads. The Senate panel is probing the FDA's oversight of medical-device components.

Medtronic said in the same SEC filing that it is the subject of a Justice Department probe into illegal physician payments. The U.S. attorney's office for the Eastern District of Pennsylvania asked for information on payments or gifts to physicians or physician's groups related to the purchase of the company's cardiac stents and cardiac-therapy devices. The U.S. attorney also asked Medtronic to provide documents related to its relationship with a specific customer. The customer wasn't identified in the SEC filing. In September, the SEC began an informal probe of Medtronic, seeking information about possible violations of the Corrupt Foreign Practices Act, which is meant to stop bribes to foreign officials.

This is not the first time Medtronic's relationships with physicians has come under scrutiny. Earlier this year, Sen. Charles Grassley, R-Iowa, requested information from Medtronic about the company's payments to orthopedic surgeons, and questioned whether they improperly influenced physician decisions about which products to use. Monetary agreements with physician consultants are common in the medical device industry, where doctors are paid for their work developing products and then, in some cases, for helping to train other doctors in how to use the products. Medtronic insists that it only provides physicians with compensation that is fair, relative to current market values, and is compliant with the law.

Medtronic Asks Supreme Court to Ban Personal Injury Lawsuits Against Defective Medical Devices, Drugs

Tue, 04 Dec 2007 00:00:00 -0800

Medtronic, Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead and several other defective medical devices, will try to convince the US Supreme Court that people injured by dangerous medical devices and drugs should not be allowed to sue manufacturers if those products have been approved by the Food & Drug Administration (FDA). If Medtronic is successful, the thousands of people injured by the company's defective devices, as well as those hurt by faulty drugs and devices made by other manufacturers, would not be able to receive compensation for their injuries in state courts.

The Medtronic Supreme Court case stems from a lawsuit filed by the family of a New York man who suffered severe medical complications when a Medtronic-made balloon catheter burst during a procedure to clear his arteries. The man's family sued Medtronic, claiming his injuries were caused by the catheter's negligent design, manufacture and labeling, despite the fact the device had won FDA approval. The case was thrown out by a US District Court judge and then by the US Court of Appeals. The family is now appealing to the US Supreme Court.

Medtronic is arguing that because Congress granted the FDA the authority to determine whether products are safe and effective, state judges and juries should not be allowed to second-guess the FDA once a product is approved for use. Now, the Supreme Court must decide if Congress intended to bar state law claims when it gave the FDA authority to regulate medical devices in 1976. That law clearly says that states can't maintain requirements that are different from federal standards. But Congress didn't specify that those federal standards preempted state common law claims, and device manufacturers didn't argue that they did until recently. Medtronic and other companies are claiming that allowing state personal injury lawsuits against the makers of defective medical devices and drugs would amount to a state "requirement" different from FDA requirements because such complaints are based on state laws.

Consumer and patient advocates are vigorously opposed to Medtronic's arguments. They fear that by removing the threat of lawsuits, manufacturers like Medtronic would have no incentive to keep devices and drugs that they know are defective off the market. And the FDA cannot be trusted to keep consumers safe, because the agency has approved some drugs - like Vioxx- and devices based on sloppy or falsified test data. Patient advocates insist that often, lawsuits are the only way evidence of such fraud or faulty tests ever come to light. Finally, consumer advocates fear that the FDA is simply not up to the job of keeping unsafe drugs and medical devices away from the public. A report issued Friday by three members of the FDA's own Science Board said that the agency was so poorly organized and short of funds that it could not adequately protect the public.

Legal experts say that should the Supreme Court rule in Medtronic's favor, it will affect lawsuits already filed by tens of thousands of Americans challenging the safety of dangerous drugs like the Ortho Evra birth control patch and a host of medical devices. If that happens, the pubic will be robbed of the last possible safety net against defective drugs and medical devices.

Medtronic Sprint Fidelis Defibrillator Lead Could Have Sensing Capability Problems

Tue, 27 Nov 2007 00:00:00 -0800

Medtronic Sprint Fidelis Defibrillator Lead wires could have even more problems than once thought. While the Sprint Fidelis Leads where recalled by Medtronic in October because of a higher-than-normal fracture rate, there is now concern that the leads could also have poor sensing capabilities. This defect could cause a Medtronic defibrillator to deliver inappropriate shocks to the heart.

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

The Sprint Fidelis Lead was designed to replace Medtronic’s Sprint Quattro models, and it is one of the thinnest defibrillator lead wires on the market. Since it was introduced in 2004, Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators. But within a couple of years of the Sprint Fidelis Lead’s introduction, emergency rooms around the country began to see patients injured by the fractured device. A data analysis performed by the Minneapolis Heart found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor.

But lead fractures might be only one of the Sprint Fidelis’ problems. According to a the website TheStreet.com, a report by a Deutsche Bank analyst regarding the impact of the Sprint Fidelis Lead wire recall on Medtronic’s bottom line said that more bad news could be on the way. The analyst wrote that there had been reports that the Sprint Fidelis Lead wires had poor sensing capability. The Deutsche Bank report said that concerns over the Sprint Fidelis Defibrillator Lead wires sensing capabilities “is something we have learned from our clinicians contacts, and we could see published in medical journals.”

The Sprint Fidelis Defibrillator Lead recall has hurt Medtronic’s bottom line. Earlier this week, the company said that revenue in its Cardiac Rhythm Disease Management unit was down by $130 million, and it also absorbed $31 million in costs to write off the Sprint Fidelis leads recalled during the quarter. Last month, Medtronic had predicted a $150 million to $250 million loss of second-quarter revenue and inventory write-off costs of $15 million to $20 million. The Deutsche Bank report also speculated that further problems with the Sprint Fidelis Lead wire could weigh even more heavily on Medtronic’s finances. The analyst wrote that the Sprint Fidelis problems could result in permanent loss of market share in implantable defibrillators to other company’s such as St. Jude Medical and Boston Scientific.

Sprint Fidelis Defibrillator Lead Wire Recall Means Return of Safer Sprint Quattro Lead

Fri, 23 Nov 2007 00:00:00 -0800

Medtronic Inc. has had to go back to an old-reliable in the wake of last month’s Sprint Fidelis Defibrillator Lead recall. In order to continue to meet the demand for defibrillator lead wires, Medtronic has begun supplying health care providers with the Sprint Fidelis’ predecessor, the Sprint Quattro. The Sprint Quattro Defibrillator Lead is a thicker wire than the recalled Sprint Fidelis, and for some time before the recall, it was becoming apparent that the older Sprint Quattro model was safer than new Medtronic lead.

Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.

The Sprint Fidelis Lead was designed to replace Medtronic’s Sprint Quattro models, and it was one of the thinnest defibrillator lead wires on the market. Prior to the recall, Sprint Fidelis Leads had been implanted with 90% of Medtronic’s defibrillators since being introduced in 2004. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide, and about 235,000 people still have these leads in their chests.

Within a couple of years of the Sprint Fidelis Lead’s introduction, emergency rooms around the country began to see patients injured by the fractured device. The problems were disturbing enough that the Minneapolis Heart Institute decided to conduct a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country. The researchers found that the thinner Sprint Fidelis Lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis Lead, and the study authors informed the Food & Drug Administration (FDA) that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.

But even as it sent out that letter, Medtronic was gathering evidence that the Sprint Fidelis Lead was more prone to fracturing than the Sprint Quattro. According to the Wall Street Journal, data collected by Medtronic revealed that from late 2004 through February 2007, there had been more than 200 fractures reported for Sprint Fidelis Leads. That was compared to 64 for Medtronic’s Sprint Quattro Leads. Then, sometime between August and September of this year, Medtronic said it learned of 5 deaths linked to Sprint Fidelis Lead fractures. And by October, the Medtronic analysis had revealed that the defective Sprint Fidelis Leads had a 2.3% fracture rate within 30 months of implantation. Those grim statistics where finally enough to persuade Medtronic to recall the defective Sprint Fidelis Defibrillator Lead.

The Sprint Fidelis Defibrillator Lead recall sent Medtronic scrambling to get more Sprint Quattro models onto the market. Despite that, the company says it won’t have any trouble meeting the demand for Sprint Quattro Leads. In light of the recall, it looks as though there was never any need for Medtronic to replace the more reliable Sprint Quattro Defibrillator Leads.

Medtronic Faces Sprint Fidelis Lead Shareholder Lawsuit

Wed, 21 Nov 2007 00:00:00 -0800

Medtronic Inc.’s Sprint Fidelis Defibrillator Lead recall has resulted in a shareholder lawsuit against the company. The plaintiff filing the lawsuit accuses Medtronic of withholding information regarding defects in the Sprint Fidelis Defibrillator lead.

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

The Sprint Fidelis Defibrillator Lead recall has hurt Medtronic’s bottom line. Earlier this week, the company said that revenue in its Cardiac Rhythm Disease Management unit was down by $130 million, and it also absorbed $31 million in costs to write off the Sprint Fidelis leads recalled during the quarter. Last month, Medtronic had predicted a $150 million to $250 million loss of second-quarter revenue and inventory write-off costs of $15 million to $20 million.

The plaintiff, whose lawsuit was filed in the US District Court in Minneapolis, is seeking class action status for the lawsuit for those who bought Medtronic stock between June 25 and October 15, 2007. During that period, the suit alleges that Medtronic made false and misleading statements about the leads, claiming in a securities filing that the product enjoyed "strong market acceptance." But just prior to that period, the Minneapolis Heart Institute conducted a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country. The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than an earlier Medtronic defibrillator lead. That study was published in the March issue of the medical journal “Heart Rhythms”. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the Food and Drug Administration that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor.

The Medtronic Sprint Fidelis Lead shareholder lawsuit is seeking unspecified damages from the company, and from Medtronic Chairman Arthur Collins Jr., CEO William Hawkins III and CFO Gary Ellis.

Medtronic Profits Down After Sprint Fidelis Defibrillator Lead Recall

Tue, 20 Nov 2007 00:00:00 -0800

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, said its profits have slipped 2% as a result of last month's Sprint Fidelis recall. To make matters worse for the company, many are now asking if Medtronic acted quickly enough to get its faulty Sprint Fidelis Lead wires off the market.

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

Earlier this year, the Minneapolis Heart Institute conducted a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country. The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than an earlier Medtronic defibrillator lead. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis Lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.

Some Medtronic critics have argued that Medtronic should have done more back in March. Dr. Sidney Wolfe, from the consumer advocacy group Public Citizen, is one of them. Some 1,194 associated injuries had been reported — up from 296 injuries reported in the first 10 months of 2006, according to a letter Wolfe wrote to the Food & Drug Administration. "Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of this year?" he wrote.

For its part, Medtronic maintains that it acted properly, and others fault the FDA for not leaning on the company to do more in March 2007. Dr. Robert Hauser told Minneapolis Public Radio that when Medtronic sent a letter to physicians stating they 'may' have a problem, the FDA had a responsibility to act. "In retrospect, what might've been done was for the FDA to say simply, 'Look, if you think you have a problem, why don't you stop implanting until you figure out what the problem is, ’” Hauser said.

At any rate, it is now Medtronic that will deal with the fallout from the Sprint Fidelis Lead recall. The recall hurt revenue in Medtronic’s Cardiac Rhythm Disease Management unit by $130 million, and it also absorbed $31 million in costs to write off the Sprint Fidelis leads recalled during the quarter. Last month, Medtronic had predicted a $150 million to $250 million loss of second-quarter revenue and inventory write-off costs of $15 million to $20 million.

Medtronic Sprint Fidelis, St. Jude Riata Defibrillator Lead Wires Endanger Patients

Mon, 19 Nov 2007 00:00:00 -0800

People with a Medtronic or St. Jude implantable defibrillators should know that some of these defibrillators’ lead wires—specifically in the Medtronic Sprint Fidelis and St. Jude Riata lead wires—have fractured, perforated patient heart walls, or caused device failure. In some cases, these malfunctions of the Medtronic Sprint Fidelis Lead and the St. Jude Riata Defibrillator Lead have led to additional cardiac procedures or complications and even death.

Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator. When a defibrillator wire detaches or breaks, the device will fail leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made it through the heart wall.

There is growing speculation that the thin design of Sprint Fidelis and Riata lead wires are causing the perforation and fracturing problems seen recently due to too-thin diameter models. The Food and Drug Administration is currently investigating the link between defibrillator lead wire diameter and safety and performance issues.

Although one woman exhibited no problems, doctors discovered her perforation from a St. Jude Riata Lead in a routine visit five weeks after her defibrillator implant. The device had not been delivering a sufficient jolt. St. Jude Riata defibrillator lead wires have been detaching from patients’ hearts and perforating patients’ heart walls, with one patient’s wire moving from inside the heart to within millimeters of the patient's skin. While such malfunctions can happen with any defibrillator lead, evidence is emerging that this sort of detachment and perforation is occurring more frequently than expected with the St. Jude leads. Massachusetts General Hospital reported a perforation rate of 3.8 percent, or five out of 130, for the St. Jude Riata Defibrillator Lead. Doctors from New York Hospital Queens reported that of 59 St. Jude Riata Defibrillator Lead implants, five perforated; the hospital no longer uses the defective leads. St. Jude Riata insists its internal monitoring indicates their lead is no more likely to perforate patients’ hearts than other leads and their lead has a minimal 0.33% perforation rate; however, it is possible that their data is incomplete since many physicians are not reporting perforation incidents. St. Jude Riata has not issued a recall.

Medtronic—the nation’s largest maker of implanted heart devices—acknowledged five patient deaths linked to breaks in its Sprint Fidelis Lead wires and issued a recall last month. Medtronic has used the defective Sprint Fidelis Leads since 2004 on more than a quarter of a million patients. The Medtonic Sprint Fidelis Lead wires are prone to fracture and can cause device malfunctions such as unnecessarily jolting the heart or failing to deliver life-saving defibrillation. The leads’ failure rate is considered significant.

Medtronic Sprint Fidelis Defibrillator Lead Patients Face Uncertainty

Fri, 16 Nov 2007 00:00:00 -0800

The Medtronic Sprint Fidelis Defibrillator Lead wire, which was recalled last month for a higher –than-normal fracture rate, continues to endanger thousands of people.   Because it is dangerous to replace a defibrillator lead, patients who received a defective Sprint Fidelis Lead must live with the knowledge that their Medtronic Sprint Fidelis Defibrillator Lead could one day fracture, leaving them at risk for serious injury and even death.

Medtronic suspended sales of the Sprint Fidelis Lead after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

But it turns out that Medtronic may have been able to spare some of these patients the anxiety brought on by the Sprint Fidelis Defibrillator recall. Even before it went to market, Medtronic started a study of the Sprint Fidelis Lead. According to a report in the Wall Street Journal, that study revealed that from late 2004 through February 2007, there had been more than 200 fractures reported for Sprint Fidelis Leads. That was compared to 64 for Medtronic’s other defibrillator leads. But sources have told the Wall Street Journal that at a July 19 internal meeting to discuss the problem, Medtronic’s management still insisted that the number of Sprint Fidelis Lead fractures was not “statistically significant”.

Earlier this year, the Minneapolis Heart Institute decided to conduct a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country. The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than an earlier Medtronic defibrillator lead.   As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.

By October, however, Medtronic could no longer ignore reports that the Sprint Fidelis lead was fracturing at unusually high rates.   By then, the company’s analysis had revealed that the defective Sprint Fidelis Leads had a 2.3% fracture rate within 30 months of implantation. Finally, unable to deny that such numbers were not “statistically significant,” Medtronic recalled its defective Sprint Fidelis Leads. But by that time, thousand of people had been implanted with these leads. Now, these unfortunate patients have no choice but to live with the knowledge that their Sprint Fidelis Lead could fracture at any time, placing them in mortal danger.

Defective Medtronic Sprint Fidelis Lead Fracture Reports Ignored by Company, FDA for Months Prior to Recall

Tue, 30 Oct 2007 00:00:00 -0700

Medtronic Inc. knew that its Sprint Fidelis Defibrillator Leads were fracturing at higher-than-usual rates for months. Yet, the company appears to have dragged its feet in getting the defective Sprint Fidelis Lead off the market. Medtronic even went so far as to blame physicians for the problems, claiming that they weren’t implanting the defective Sprint Fidelis Lead properly. What’s even worse, the Food & Drug Administration (FDA), which never required the defective medical device to undergo clinical testing, was oblivious to the increasing reports of Sprint Fidelis Lead problems.

Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

The Sprint Fidelis Lead was designed to replace Medtronic’s Sprint Quattro models, and it is one of the thinnest defibrillator lead wires on the market. Since it was put on the market in 2004, Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide, and about 235,000 people still have these leads in their chests. But in spite of such widespread use, the FDA never required the Sprint Fidelis Leads to be tested in humans before they were marketed, and it did not monitor the device after it was introduced. The FDA considered the Sprint Fidelis Lead to be a modification over the earlier Sprint Quattro, so it only required Medtronic to conduct limited laboratory testing prior to its introduction.

Within a couple of years of the Sprint Fidelis Lead’s introduction, emergency rooms around the country began to see patients injured by the fractured device. The problems were disturbing enough that the Minneapolis Heart Institute decided to conduct a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country. The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.

Despite being informed of the Minneapolis Heart Institute’s Sprint Fidelis Lead study, the FDA did nothing. Medtronic had concluded that the number of Sprint Fidelis Lead fractures were not “statistically significant” and blamed most of them on surgical errors. An FDA spokesperson told the Wall Street Journal that the agency did not require any post-market surveillance of the Sprint Fidelis Lead because “no issues were raised in the premarket review that suggested the need for a postmarket study.” But of course, the FDA had not required a premarket clinical trial of the Sprint Fidelis Lead. Because of this, patients and their doctors had no way of knowing that the Sprint Fidelis Lead implanted with a Medtronic defibrillator could be a dangerous ticking time bomb.

But Medtronic knew. It had started a study of the Sprint Fidelis Lead even before it went on the market. According to the Wall Street Journal, that study revealed that from late 2004 through February 2007, there had been more than 200 fractures reported for Sprint Fidelis Leads. That was compared to 64 for Medtronic’s other defibrillator leads. But sources have told the Wall Street Journal that at a July 19 internal meeting to discuss the problem, Medtronic’s management still insisted that the number of Sprint Fidelis Lead fractures was not “statistically significant”.

Then, sometime between August and September of this year, Medtronic said it learned of 5 deaths linked to Sprint Fidelis Lead fractures. And by October, the Medtronic analysis had revealed that the defective Sprint Fidelis Leads had a 2.3% fracture rate within 30 months of implantation. Finally, unable to deny that such numbers were not “statistically significant,” Medtronic recalled its defective Sprint Fidelis Leads. But thousand of people have been implanted with these leads, and now they must live with the knowledge that their Sprint Fidelis Lead could fracture at any time, placing them in mortal danger. Why the defective Sprint Fidelis lead was not removed from the market earlier, is a question that Medtronic is going to have to answer.

Medtronic Sprint Fidelis Defibrillator Lead Lawsuit Claims Center Opens to Aid Victims - Free Case Review by our Medtronic Lead Injury Lawyers and Attorneys for a Potential Lawsuit.

Wed, 24 Oct 2007 00:00:00 -0700

Keywords: Lawsuit | Medtronic | Lawyer | Lead | Fidelis | Attorney | Recall | Injury

Parker Waichman Alonso LLP Announces Opening of Dedicated Claims Center To Evaluate Numerous Possible Lawsuits Related to Defective Sprint Fidelis Leads Used With Medtronic Implantable Defibrillators.

(New York) October 24, 2007 – The defective Medtronic Sprint Fidelis Defibrillator Leads were implanted into hundreds of thousands of people, leaving all of them at risk for serious injury if a Sprint Fidelis Lead fractures. As a result of this, Parker Waichman Alonso LLP has opened a dedicated Claims Center within their office to review the potential lawsuits of people who were implanted with defective Sprint Fidelis Leads used with Medtronic defibrillators.   Medtronic suspended sales and recalled all unused Sprint Fidelis Leads on October 15, 2007 after receiving reports of at least 5 fatalities linked to lead fractures. Parker Waichman Alonso LLP recently filed a lawsuit on behalf of a man who had to undergo a dangerous and life-threatening surgical procedure after a Sprint Fidelis Lead fractured. Parker Waichman Alonso LLP is seeking class action status for this lawsuit to represent all persons in the United States who were implanted with defective leads manufactured by Medtronic, Inc.

If you or a loved one received a Sprint Fidelis Lead with a Medtronic implantable defibrillator, please contact our claims center by visiting www.yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

The Sprint Fidelis Lead is a wire that is used to attach a Medtronic implantable defibrillator to the heart.   The Sprint Fidelis Lead was first introduced by Medtronic in 2004, and has been used with most of the company’s implantable defibrillators since then. This component is used in cardiac defibrillators -- or complex devices with defibrillation capacity -- and not in conventional pacemakers. Some patients with congestive heart failure use devices that include this defibrillation ability, and those are among the machines that use the Sprint Fidelis Lead.

Medtronic’s Sprint Fidelis Leads have been shown to have a continuing fracture problem. This defect can cause the defibrillators to deliver a massive and painful electrical shock, or it can cause the device to fail to administer a lifesaving shock when necessary.   Such defects were discussed in an article written by doctors at The Minneapolis Heart Institute, one of the premier heart institutes in the world.   The researchers at the Minneapolis Heart Institute compared data regarding lead failures in both the Sprint Fidelis models and Medtronic’s earlier Sprint Quattro models. The study found the thinner Sprint Fidelis Lead had a higher chance of fracturing than the Sprint Quattro. According to Medtronic’s own estimate, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis Lead will experience fracture within 30 months of having a defibrillator implanted.

When a Sprint Fidelis Lead fractures, a patient must undergo a surgical procedure that can tear and scar the heart tissue and veins through which the Sprint Fidelis Lead wire runs.   The surgery to replace a defibrillator lead wire is far riskier than having the device itself replaced.

About Parker Waichman Alonso LLP:
Parker Waichman Alonso LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker Waichman Alonso LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective products, drugs and medical devices.

For more information on Parker Waichman Alonso LLP, please visit: www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

CONTACT:    Parker Waichman Alonso LLP
                  David Krangle, Esq.
                  (800) LAW-INFO
                  (800) 529-4636
                  info@yourlawyer.com
                  www.yourlawyer.com

Medtronic Defibrillator Sprint Fidelis Lead Recall Sparks Congressional Investigation

Tue, 23 Oct 2007 00:00:00 -0700

This month’s Medtronic defibrillator Sprint Fidelis lead recall has prompted Congress to initiate of review of the procedures the Food & Drug Administration (FDA) uses to test heart device components.   The review is being undertaken by the House of Representatives Committee on Oversight and Government Reform, which sent a letter to the FDA asking officials there a series of questions about the agency’s oversight of defibrillator leads.

Medtronic suspended sales and recalled all unused Sprint Fidelis leads last Monday, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with defective Sprint Fidelis leads are being told to leave the components in place unless they fracture.

When it issued the Sprint Fidelis lead recall, Medtronic estimated that about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. Apparently, it was a problem that the company had known about for months.   Since it was introduced to the market in 2004, there have been 599 reports of lead fractures as of January 2007. And it seems as though the fracture problems became worse over time. In the first two months of 2006, there were 27 reports of the Sprint Fidelis lead fracturing. But in the first two months of 2007, there were 152 reports. And since January 10, 2007, there have been a staggering 1,030 reports of fractures.

Shortly after the Sprint Fidelis lead recall, it was learned that the FDA had not required extensive testing of the vital defibrillator component before it went on the market. Although the agency had required Medtronic to test an earlier version of a defibrillator lead in patients before approval, it had not required the company to do so for the defective Sprint Fidelis lead. That was because officials at the FDA had determined that the Sprint Fidelis lead was not a significant enough change from the design of its predecessor. Instead, the FDA required the Sprint Fidelis lead to pass only tests intended to identify design flaws. Those were principally mechanical stress tests meant to recreate the pressures in the body.   The FDA is trying to figure out why those tests did not pick up the defects in the Sprint Fidelis lead.

Some medical experts have questioned the FDA’s decision not to put the defective Sprint Fidelis lead through more clinical tests. Though its predecessor, the Sprint Quattro, has a good performance history, the Sprint Fidelis lead is a significantly thinner wire. Many believe that thinness made the defective Sprint Fidelis lead more apt to fracture.

The issues that the Congressional Committee is investigating include the FDA’s decision not to subject the defective Sprint Fidelis lead to more rigorous testing, and why all defibrillator leads are not subject to the same level of scrutiny as the heart devices themselves.

Medtronic Sprint Fidelis Defibrillator Lead Poses Greatest Danger to Young People

Fri, 19 Oct 2007 00:00:00 -0700

Defective Sprint Fidelis leads used with Medtronic implantable defibrillators could be far more dangerous for young people and pediatric patients.   What’s more, Medtronic, Inc. could be vastly understating the fracture rate of the Sprint Fidelis Defribrillator lead, as some studies have found that rate to be significantly higher than the 2.3% reported by Medtronic.

Earlier this week, Medtronic announced that it was suspending sales of the defective Sprint Fidelis lead, a thin wire that connects an implantable defibrillator to the heart. The company said that the lead could fracture, causing the defibrillator to either send a massive, painful electrical shock to the heart; or prevent the defibrillator from emitting a necessary, lifesaving shock.   According to Medtronic’s own estimate, about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted.   Those patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to have the wire replaced. At least five deaths have been attributed to the defective Sprint Fidelis leads.

According to a recent article in the Wall Street Journal, since being introduced in 2004, Sprint Fidelis leads have been implanted in 268,000 patients. Of those, 2,085 were in people under 21. The Sprint Fidelis lead was considered a good choice for children, adolescents and young people because the thinness of the component made the wire easier to thread into tiny blood vessels. But because children and young people are more active and their hearts beat faster than adults, defibrillator leads are more likely to fail in younger patients.

And the evidence does suggest that these patients could be at the highest risk for a Sprint Fidelis lead fracture. According to the Wall Street Journal, preliminary data from physicians at 32 institutions indicated that the vast majority of people who experienced fractures of Sprint Fidelis leads were under the age of 21. That survey is similar to Medtronic’s own findings released Monday. According to the company, the rate of fracture for Sprint Fidelis leads 30 months after implantation was 3.8% for patients younger than 21.   The failure rate stated by Medtronic for the entire population was 2.3%.

But even the lower number could be off.   At least two independent studies cited by the Wall Street Journal show much higher rates of Sprint Fidelis fracture rates. Data compiled by a researcher at Northwestern University’s Feinberg School of Medicine found that over 30 months, the fracture rate in 569 patients with the defective leads was a staggering 6.7%. A second survey by the same researcher found that of 304 patients implanted with a particular Sprint Fidelis model, the fracture rate stood at 4.9%.

Despite the dangers posed by the defective Sprint Fidelis lead, most doctors are telling patients to leave them in place if they haven’t fractured. The procedure to replace a defibrillator lead is extremely invasive and dangerous. The surgery can cause blood vessels and other tissue to tear and scar. In fact, replacing a defibrillator lead is far riskier than replacing the defibrillator itself.

Medtronic Inc. Ignored Sprint Fidelis Lead Problems for Months

Fri, 19 Oct 2007 00:00:00 -0700

Medtronic Inc. is facing serious questions about its handling of problems with its defective Sprint Fidelis leads, a component of implantable defibrillators.   Medtronic had been receiving reports of Sprint Fidelis lead fractures for months, yet only decided to suspend sales of the components this week. Considering the injuries that can result from a lead fracture, and the dangerous operation patients must undergo to have a lead replaced, many patient advocates are bewildered that Medtronic allowed the defective Sprint Fidelis leads to stay on the market for so long.

Medtronic suspended sales of the Sprint Fidelis leads on Monday, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads are being told to leave the defective components in place unless they fracture.

When it suspended sales of the Sprint Fidelis lead, Medtronic estimated that about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. Apparently, it was a problem that the company had known about for months.   Since it was introduced to the market in 2004, there have been 599 reports of lead fractures as of January 2007. And it seems as though the fracture problems became worse over time. In the first two months of 2006, there were 27 reports of the Sprint Fidelis lead fracturing. But in the first two months of 2007, there were 152 reports. And since January 10, 2007, there have been a staggering 1,030 reports of fractures.

What’s more, problems with the Sprint Fidelis lead had also been reported in at least one medical journal. The article, written by doctors at The Minneapolis Heart Institute was based on a study of the incidence of lead failures in the Sprint Fidelis models compared to the Sprint Quattro models, an earlier lead made by Medtronic. The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the Food & Drug Administration that the defective Sprint Fidelis lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.

On Tuesday, Charles Grassley, a prominent Republican Senator from Iowa, sent letters to Medtronic demanding a meeting with the company to discuss the handling of the Sprint Fidelis lead problems, and already several lawsuits have been filed against Medtronic because of the faulty lead.   Why the defective Sprint Fidelis lead was not removed from the market in March, or even earlier, is a question that Medtronic is going to have to answer.

Defective Medtronic Defibrillator Lead Problems Known for Months, Yet FDA Did Nothing

Wed, 17 Oct 2007 00:00:00 -0700

Reports of frequent fracturing of Sprint Fidelis leads on Medtronic implantable defibrillators had been piling up for months, but the company only chose to withdraw the defective leads earlier this week. According to new reports, by January 2007, the Food & Drug Administration (FDA) knew of hundreds of cases where the Sprint Fidelis lead fractured and caused serious injuries in people with Medtronic implantable defibrillators, yet neither the agency nor Medtronic took any action at that time.

Earlier this week, Medtronic suspended sales and recalled the Sprint Fidelis lead used in its implantable defibrillators after an analysis of the company’s data showed that the lead had a continuing fracture problem. According to Medtronic’s own estimate, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted.

The Sprint Fidelis lead is a wire that runs through a blood vessel and attaches a defibrillator to the heart. Lead wires are usually one of the more fragile components of a defibrillator, but that seems to have been especially true in the case of the Sprint Fidelis lead. Since it was introduced to the market in 2004, the FDA had received 599 reports of lead fractures as of January 2007. And it seems as though the fracture problems became worse over time. In the first two months of 2006, there were 27 reports of the Sprint Fidelis lead fracturing. But in the first two months of 2007, there were 152 reports. And since January 10, 2007, the FDA has received a staggering 1,030 reports of fractures. So far, 5 patient deaths have been linked to fractures of the Sprint Fidelis lead.

And lead fractures involve far more than a damaged wire. When a defibrillator lead fails, it can cause the device to emit unnecessary and massive painful shocks to the heart. One researcher has described this event as akin to being “kicked in the chest” by a horse. Or even worse, the fractured lead can cause the defibrillator to fail to emit a life saving shock when needed. Even when a lead fracture is detected before either of those things happen, patients must undergo a dangerous and life-threatening surgery to have the wire replaced.

Despite having so many reports of Sprint Fidelis lead fractures, the FDA did not start monitoring the component until February, after the Minneapolis Heart Institute published a study of lead failures in the Sprint Fidelis models compared to the Sprint Quattro models, another type of Medtronic lead. The researchers in Minneapolis found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the lead’s possible problems, the company maintained that the fractures were partly the result of the leads not being properly implanted. For its part the FDA did nothing further in response to the Minnesota Heart Institute’s report.

Even now, the FDA insists that there was no early evidence that the Sprint Fidelis lead was more apt to break than other defibrillator lead wires. But Medtronic’s decision to pull the Sprint Fidelis lead from the market has prompted the FDA to re-examine other models of similarly sized defibrillator leads.

Medtronic Lawyer Leads Lawsuit Defibrillator Sprint Attorney Recall

Wed, 17 Oct 2007 00:00:00 -0700

Medtronic Defibrillator Defective Sprint Fidelis Lead

Keywords: Medtronic | Lawyer | Defibrillator |Attorney | Lead | Fidelis | Lawsuit

On October 15, 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal. At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

The Sprint Fidelis lead have been used in implantable Medtronic defibrillators since 2004, and most patients who received the devices since then have the faulty leads. Sprint Fidelis leads were used only in cardiac defibrillators -- or complex devices with defibrillation capacity -- and not in conventional pacemakers. Some patients with congestive heart failure use devices that included this defibrillation ability, and those were among the machines that use the Sprint Fidelis lead.

Medtronic Defibrillator Lead Recall
Medtronic decided to suspend sales of the Sprint Fidelis lead after a company review of 30 months of data showed that the defibrillator lead had a continuing fracture problem. According to the company’s own estimate, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a Medtronic defibrillator implanted. Those patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to have the wire replaced.

For the unlucky patients who experience a fracture of a Sprint Fidelis lead, three things can happen. If they are fortunate, the implantable defibrillator will beep, alerting the patient to seek immediate medical attention. Or, the fracture can create a massive electrical shock that causes the patient extreme and sudden chest pain. But most disturbingly, the fracture of a Sprint Fidelis lead can deplete the Medtronic defibrillator’s battery. If this happens, the Medtronic defibrillator can fail to deliver a necessary, life-saving shock to the heart.

In addition to suspending sales of the Sprint Fidelis lead, Medtronic also recalled all unused leads on the market. The company also advised patients with Medtronic implantable defibrillators that may have used the defective Sprint Fidelis lead to see their doctors. Replacing leads on an implantable defibrillator is far more risky than replacing the device itself, so the company was not advising that patients with a Sprint Fidelis lead have those replaced. Rather, it urged physicians to reprogram the defibrillators to minimize the problem. Medtronic said the new programming would allow the implantable defibrillators to better monitor and warn of problems with the Sprint Fidelis leads.

Medtronic Defibrillator Charging Problem
On April 16, 2004 Medtronic announced that it was recalling two heart defibrillators because they have been linked to at least four deaths and one injury. Medtronic said that some of these defibrillators have failed to charge properly which can result in the late delivery or no delivery of cardiac shock therapy.

The charging problem involves the Medtronic Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 implanted cardioverter-defibrillators. Medtronic said that most of these devices were implanted in 1997 and 1998. About 1,800 are thought to be still in use.

These devices are used to shock the heart into normal rhythm after patients suffer irregular heartbeat or fibrillation, which are rapid, life-threatening arrhythmia's, originating in the lower chambers of the heart. The defibrillators are implanted surgically in the chest. When a cardiac arrhythmia occurs, the capacitor is charged and the device delivers the appropriate shock.

Medtronic said that with the suspect defibrillators, the capacitors may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or no delivery of shock therapy. A delay or no delivery of shock therapy can be life threatening.

Medtronic Defibrillator Lawsuit Lawyers
If you or a loved one suffered injuries from a Medtronic Defibrillator, please fill out the form at the right for a free lawsuit case evaluation by a qualified defective medical device attorney.