Yourlawyer.com (Medtronic Pacemaker (Sigma or Kappa) 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.

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 Issues Class I Recall for Some Pacemakers

Thu, 11 Jun 2009 00:00:00 -0700

Medtronic Inc. is issuing a Class I recall for certain Medtronic Kappa and Sigma pacemakers because of wiring issues that may cause the devices to fail. A Class I recall is the Food & Drug Administration's (FDA) most serious recall action, and is issued when there is a reasonable probability that the use of the device will cause serious adverse health consequences or death.

The Medtronic pacemakers involved in this recall include:

Kappa Series 600/700/900
Sigma Series 100/200/300

According to the FDA, the recall affects around 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted in patients worldwide. Most of the devices affected by the recall have been implanted in patients five years or longer.

On May 18, 2009, Medtronic Inc. issued a letter to physicians, alerting them to the problem. The company followed up with a patient letter on May 27, 2009. At that time, the company warned that the devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. In the May 18 letter to doctors, Medtronic said it had received reports of two patient deaths where it is possible, but unclear whether a wire separation issue may have been a factor.

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

The FDA is recommending that patients with the cited models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 1-800-505-4636 or going to the firm's Web site. Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Meditronic Recall Sigma Lawyer Kappa Pacemaker Lawsuit

Thu, 11 Jun 2009 00:00:00 -0700

Medtronic Pacemaker Recall Lawyer

Keywords: Meditronic Recall Sigma Lawyer Kappa Pacemaker Lawsuit

If you have a Medtronic Kappa or Sigma pacemaker, and have experienced symptoms associated with abnormal heart rate, such as fainting or lightheadedness, your device may be defective. In June 2009, Medtronic Inc. issued an urgent recall of certain Kappa and Sigma pacemakers because of wiring problems that could cause the devices to fail. Our Medtronic pacemaker recall lawyers are currently offering free case evaluations to victims of these defective devices.

Thousands of people are currently implanted with one of these Medtronic pacemakers, and there is no way to detect a problem before the device actually fails. The trauma caused by faulty Kappa and Sigma pacemakers is immeasurable. People with one of the recalled Medtronic pacemakers are at a high risk of serious injury and even death.

Medtronic Inc. must be held accountable for the pain and suffering caused by its defective pacemakers. If you or someone you love was injured by one of Medtronic's faulty Kappa or Sigma pacemakers, you may be entitled to compensation. Please contact one of our Medtronic pacemaker recall lawyers right away to protect your legal rights.

Medtronic Kappa and Sigma Pacemaker Recall

In June 2009, the Food & Drug Administration (FDA) announced a Class I recall of several models of Kappa and Sigma pacemakers manufactured by Medtronic Inc. A Class I recall is the agency's most serious type of recall action, and is issued when there is a high probability that a defective device will cause serious injury or death.

The Kappa and Sigma pacemaker recall was issued because the devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

The Medtronic pacemaker recall involved roughly 21,000 devices. Most of the devices affected by the recall have been implanted in patients five years or longer.

The Medtronic pacemakers involved in this recall include:

Kappa Series 600/700/900
Sigma Series 100/200/300

Patients with the cited models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 1-800-505-4636 or going to the firm’s Web site. Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Medtronic Letter to Doctors

The Class I Medtronic pacemaker recall was preceded by a letter Medtronic Inc. issued to doctors in May 2009, alerting them to problems with some Kappa and Sigma pacemakers. The letter discussed two different wire separation issues affecting some Sigma and Kappa pacemakers. Medtronic said it had received reports of two patient deaths where it is possible, but unclear whether a wire separation issue may have been a factor. A total of 37,000 devices may have been affected by these two issues.

The first issue involved an estimated 15,200 active Kappa devices and 6,100 active Sigma devices, manufactured primarily between November 2000 and November 2002. It was this issue that prompted the 2009 Class I Kappa and Sigma pacemaker recall.

Medtronic said it had observed 285 Kappa devices and 131 Sigma devices with this failure mechanism. Its modeling predicted 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 Kappa/Sigma wiring issue responsible for the 2009 Class I recall. There are currently an estimated 15,600 active implants from this 2005 Sigma device subset, Medtronic said.

Medtronic said that for most patients, device failure from either of these problems 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 Pacemaker Recall Lawsuit

The injuries caused by a defective Medtronic pacemaker are painful and traumatic. In many cases, patients implanted with one of these pacemakers will need to undergo additional surgery to have their device replaced. Sadly, in some instances, injuries from a recalled Kappa or Sigma pacemaker may prove fatal.

Our Medtronic pacemaker recall lawyers will do everything legally possible to make sure Medtronic Inc. is held accountable for the suffering caused by its defective Kappa and Sigma pacemakers. If you would like to discuss filing a Medtronic pacemaker lawsuit, please fill out our online form or call 1-800 LAW INFO (1-800-529-4636) right away.