http://www.yourlawyer.com/topics/overview/St_Jude_Defibrillators Sat, 21 Nov 2009 04:58:58 -0800 pixel-app en http://www.yourlawyer.com/articles/read/16753 Thu, 16 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16753 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.

]]> http://www.yourlawyer.com/articles/read/16472 Thu, 23 Apr 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16472
The filing stated that the FDA inspected St. Jude Medical’s Atrial Fibrillation (AF) Division’s catheter facility on a number of occasions from December 8 and December 19 and notified St. Jude Medical on December 19 that it observed issues with the manufacture and assembly of its Safire ablation catheter, reported BizJournal, which fix irregular heartbeats and destroy damaged and diseased tissue with heat, explained the Associated Press (AP). The warning letter was issued last Friday, said the AP.

The FDA said it would not approve new devices for manufacture at the St. Jude Medical plant until the firm corrects the outstanding problems, said the AP, noting that faulty record keeping was among the problems cited.

Typically, catheter systems consist of an energy generator and an attachable catheter, which is used on the patient's tissue, said the AP.

This is not the first time St. Jude Medical has been the subject of controversy over its products. The St. Jude Symmetry Bypass Aortic Connector has been associated with a high occurrence of heart attacks, respiratory failure, and has been linked to several deaths, with adverse effects that include graft narrowing, valve leakage, failed deployment, and occlusion. The St. Jude Symmetry is commonly used in "beating heart" or "off machine" heart bypass surgery, which has gained in popularity because it eliminates the need for the patient to be connected to a lung machine during bypass surgery and enables thoracic surgeons to attach saphenous (leg) vein grafts to the aorta without sutures and without clamping the aorta during the procedure.

The St. Jude Medical Symmetry device was approved in 2001 after an abbreviated approval process; thousands of the devices have since been implanted in patients. Despite adverse reports, St. Jude Medical neither conducted clinical trials or testing of a larger segment of the post-cardiac bypass population, nor has it made any alterations in design or manufacture to lessen the great danger the connector poses to patients.

Also, St. Jude Medical said it identified a memory chip problem in some of its older implantable cardioverter defibrillators (ICDs) devices, which stems from a memory chip St. Jude Medical used through 2002 that is susceptible to background radiation. St. Jude Medical notified doctors and federal regulators of a software problem in some models of its ICDs that could cause the heart-shocking device to malfunction. About 39,000 patients are affected by this news.

ICDs are implanted devices the size of a stopwatch that are placed in the upper chest and shock or pace an irregular heart beat back into rhythm. In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the heart. The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. A second problem could cause a temporary increase in the device's pacing rate. In addition to its shocking therapy, some patients need an ICD that can pace their heart, as well.

]]> http://www.yourlawyer.com/articles/read/15657 Thu, 11 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15657 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.

]]> http://www.yourlawyer.com/articles/read/14480 Thu, 29 May 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14480 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.

]]> http://www.yourlawyer.com/articles/read/14418 Fri, 16 May 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14418
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."

]]> http://www.yourlawyer.com/articles/read/13343 Mon, 19 Nov 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13343 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.

]]> http://www.yourlawyer.com/articles/read/13316 Tue, 13 Nov 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13316 St. Jude Riata Defibrillator Lead wire is more prone to cause heart perforations are overstated, and that its own data shows the Riata Lead is safe.  However, at least one heart expert has disputed St. Jude’s contention, telling the Wall Street Journal that the company’s data could be misleading since physicians don’t always report instances of heart perforations from defibrillator lead wires.

An article published online yesterday by the medical journal “Pace” detailed four instances where St. Jude Riata Defibrillator Leads detached and poked holes through the heart wall.     In one of those instances, the St. Jude Riata Defibrillator Lead came within just 7 millimeters of poking through a patient’s skin. In an editorial accompanying the “Pace” article, Dr. Stephen Vlay, a cardiologist for Stony Brook University in New York, wrote that the problems with the St. Jude Riata Defibrillator Leads could be due to an “inherent design flaw, at least in some models of the Riata lead.”

A defibrillator lead is a thin wire that attaches an implantable defibrillator to the heart.  When a defibrillator lead wire detaches, it can poke a hole through the heart wall.   If this happens the heart can bleed into the pericardial sac around it, leading to a lethal condition called cardiac tamponade. While such malfunctions can happen with any defibrillator lead, evidence is emerging that such detachment and perforation is occurring more frequently than expected with the St. Jude Riata Defibrillator Leads.

The “Pace” article is not the first to detail detachment and perforation problems with the St. Jude Riata Defibrillator Lead. Earlier this year, the medical journal “Heart Rhythm” reported that the St. Jude Riata Defibrillator Lead had a higher perforation rate than what had been stated by the manufacturer.  According to that article, doctors at Massachusetts General Hospital reported a perforation rate of 3.8% - or 5 out of 130 – for the St. Jude Riata Defibrillator Lead.  Doctors from New York Hospital Queens also reported to “Heart Rhythm” that of 59 St. Jude Riata Defibrillator Leads implanted there, five had perforated.   New York Hospital Queens has since stopped using the defective St. Jude Riata Defibrillator Lead.

St. Jude, however, disputes those numbers, and yesterday it published a response to Dr. Vlay’s editorial in “Pace”.  The article includes data from the company's returned product analysis and new information showing that the St. Jude Defibrillator Lead wire’s incidence rate of perforation is below or at the low end of what has been reported.   St. Jude also asserted that perforation problems with the Riata Defibrillator leads could be attributed to a “combination of factors including patient characteristics, the design characteristics of the lead and implant techniques”.

Yesterday, however, Dr. Vlay told the Wall Street Journal that St. Jude’s figures on the Riata Lead’s perforation rate have not convinced him that the component is safe.  For one thing, Dr. Vlay pointed out that physicians do not always report incidents of detachment and perforations to lead manufacturers.   For that reason, St. Jude’s data is likely skewered lower, he said.

Medical device manufacturers don’t always have accurate figures regarding failures.  In October, Medtronic Inc. recalled its Sprint Fidelis Defibrillator Lead over a fracturing problem.  Month’s prior, the Minneapolis Heart Institute had informed Medtronic that the Sprint Fidelis Lead had a higher-than-normal fracture rate. At the time, Medtronic insisted that its own data indicated no such problems.  But following a new analysis of its data, Medtronic ultimately pulled the Sprint Fidelis Lead from the market in October.

]]> http://www.yourlawyer.com/articles/read/13309 Mon, 12 Nov 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13309 St. Jude Riata Defibrillator Leads.

A defibrillator lead is a thin wire that attaches an implantable defibrillator to the heart.  It is through the lead wire that electrical shocks emitted from the defibrillator will travel to the heart.  When a defibrillator lead wire detaches, the device will fail, leaving a patient at risk for death.   And if the wire perforates the heart wall, the heart can bleed into the pericardial sac around it.  This causes a lethal condition called cardiac tamponade in which pressure builds around the heart, preventing it from beating effectively.

An article to be published online today by the medical journal “Pace” details four instances where St. Jude Riata Defibrillator Leads detached and poked holes through the heart wall.     In one of those instances, the St. Jude Riata Defibrillator Lead came within just 7 millimeters of poking through a patient’s skin. In an editorial accompanying the “Pace” article, Dr. Stephen Vlay, a cardiologist for Stony Brook University in New York, wrote that the problems with the St. Jude Riata Defibrillator Leads could be due to an “inherent design flaw, at least in some models of the Riata lead.”  

Many of the St. Jude Riata Defibrillator Leads that have caused heart perforations are thin diameter models.   In October, another thin-diameter lead wire manufactured by Medtronic Inc, the Sprint Fidelis Lead, was pulled from the market because of a fracturing problem.  There is some speculation that the thin design of Sprint Fidelis and Riata lead wires are causing the perforation and fracturing problems seen recently.   According to the Wall Street Journal, the Food & Drug Administration is currently investigating the link between defibrillator lead wire diameter and such safety and performance issues.

For its part, St. Jude insists that its own monitoring of the Riata Defibrillator Lead indicates that is no more likely to perforate patients’ hearts than other lead wires.   According to the company, its data suggests that the St. Jude Riata Defibrillator Lead has only a 0.33% rate of perforation.  However, Dr. Vlay told the Wall Street Journal that St. Jude’s data might not be providing a complete picture of Riata lead failures, as many physicians do not bother reporting perforation incidents.

Dr. Vlay could be right, as “Pace” is not the only publication to report perforation problems associated with the St. Jude Riata Defibrillator Lead wires.  Earlier this year, the medical journal “Heart Rhythm” reported that the St. Jude Riata Defibrillator Lead had a higher perforation rate than what had been stated by the manufacturer.  According to that article, doctors at Massachusetts General Hospital reported a perforation rate of 3.8% - or 5 out of 130 – for the St. Jude Riata Defibrillator Lead.  Doctors from New York Hospital Queens also reported to “Heart Rhythm” that of 59 St. Jude Riata Defibrillator Leads implanted there, five had perforated.   New York Hospital Queens has since stopped using the defective St. Jude Riata Defibrillator Lead.

]]> http://www.yourlawyer.com/articles/read/10974 Sun, 06 Nov 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/10974
This letter is written to provide you with important safety information regarding a memory chip component supplied to us and used in a limited number of St. Jude Medical ICD products within the Photon and Photon Micro device families and in certain Atlas devices.

Specifically, we have identified that a particular vendor-supplied memory chip can be affected at a low frequency rate by background levels of atmospheric ionizing cosmic radiation ("background cosmic radiation"). The anomaly can trigger a temporary loss of pacing function and permanent loss of defibrillation support. Our records indicate that you may have implanted or are monitoring patients with impacted devices.

There have been no serious patient injuries or deaths reported to St. Jude Medical that are attributable to this low frequency anomaly found in the subject memory chip component. To date, an incidence of only 0.00167 of the devices at issue (60 out of 36,000) have been found to have been affected by background cosmic radiation. Although this incidence level is low, we are taking a conservative approach in advising you and the medical community about this issue.
Affected Devices

This low frequency anomaly relates to a vendor-supplied static random access memory (SRAM) chip component found in the following St. Jude Medical ICDs:

Photon DR (Model V-230HV) (certain serial numbers)
Photon Micro VR/DR (Models V-194/V-232)
Atlas VR/DR (Models V-199/V-240)
Unaffected Devices

As part of a new ICD product platform introduced in 2002, and prior to our having any knowledge of this particular anomaly, St. Jude Medical began using a different vendor and a different design of the SRAM memory chip component. Laboratory testing and clinical experience indicate that this newer generation memory chip component does not share the same susceptibility to background cosmic radiation as the earlier generation. Consequently, other St. Jude Medical ICDs and all models of CRT-D devices, including the Atlas DR model V-242 and all Epic, Epic HF, Epic +, Epic + HF, Atlas + and Atlas + HF product families, are NOT affected by this issue.
Root Cause

As you may be aware, background cosmic radiation bombards the earth constantly. While the earth's atmosphere acts as a shield and absorbs much of the cosmic radiation, some amount of high energy particles do arrive at the earth's surface.

St. Jude Medical has determined that when the subject static access memory (SRAM) chip component is exposed to background levels of atmospheric ionizing cosmic radiation it can trigger a high current drain condition. St. Jude Medical has been able to replicate this condition in a nuclear laboratory. This has also been independently confirmed by the manufacturer of this component. St. Jude Medical has not identified any tests to predict if a particular device's memory chip component will exhibit this specific anomaly.
Clinical Manifestation

In the unlikely event that a device chip is affected by background cosmic radiation, the high current drain condition will deplete the battery voltage rapidly. This can result in loss of output for a period up to approximately 48 hours. During this period, the patient would be without pacing or defibrillation therapy. After this initial period, the battery will reach a voltage level at which the device will enter its "Hardware Reset Mode." This safety mode is designed to preserve the device's ability to provide VVI pacing support. A device that has been reset to the Hardware Reset Mode will operate in the VVI mode at 60 ppm, but will not be capable of providing tachycardia detection or therapy. This will be noted by a warning message on the programmer screen upon device interrogation.
Low Probability of Occurrence

Approximately 36,000 of the devices listed above have been implanted worldwide with approximately 26,000 of these devices still remaining in service. About 8,000 of these are in service in markets outside the United States.

The estimated incidence of an anomaly of this type in the listed devices is 0.00257 over the five year projected life of each device. To date, there have been 60 reported observations (an incidence of 0.00167) of the anomaly with 53 of these being observed following device implant (i.e. 7 devices were found to have been affected by background cosmic radiation prior to device implant). The nature of the anomaly is random and constant over time.

As depicted in the Table below, once implanted, the risk of a future occurrence decreases commensurately with the passage of time over the life of the ICD product.
Time From Implant     Estimated Incidence Rate*
0 days                      0.00257
1 year                      0.00209
2 years              0.00157
3 years              0.00102
4 years              0.00046
* Assumes five year projected life for device.

Overall reliability information about the affected ICDs, as well as about other St. Jude Medical products, can be found on our web site at www.sjm.com.

It is important to note that the opportunity for early detection will increase with more frequent follow-up intervals. As shown in the Table below, increasing monitoring frequency would reduce relative patient risk.
Follow-up Frequency     Probability of Occurrence*
6 months               0.0000163
3 months               0.0000082
1 month               0.0000027
* Predicted risk of patient requiring VT/VF therapy and not receiving therapy due to this anomaly during the indicated follow-up period. The analysis assumes that a typical ICD patient will experience a VT/VF event rate of 4.8% per year based on an analysis of observed event rates in major published ICD clinical trials.
Recommendations

We realize that each of your patients is unique and we support your clinical judgment in caring for your patients. To assist in your patient care and following discussions with our independent Medical Advisory Board, St. Jude Medical recommends:

    * If it is not already your current practice, physicians should perform routine device monitoring every 3 months for patients with the affected models listed above.
    * In determining whether additional patient management or follow up may be needed, consider the low failure rate for the anomaly and the unique medical needs and situation of each individual patient, including whether the patient is pacemaker dependent or at high risk for life-threatening arrhythmias.
    * If a patient's device is found in the Hardware Reset Mode, you should arrange for device replacement as soon as possible.
    * You should continue to provide the patients with the usual admonitions to keep scheduled appointments and to report all changes in symptoms.

Should you elect to replace a subject device in a specific patient (e.g. patients who are pacemaker dependent or receive frequent VT/VF therapy), St. Jude Medical will provide a replacement device at no cost.
St. Jude Medical Contact Information

Every employee at St. Jude Medical is dedicated to providing safe, reliable and sophisticated medical devices. We strive for perfection and are disappointed when any anomaly like this occurs. ICDs and pacemakers save thousands of lives each year, and we at St. Jude Medical will continue to do all we can to provide the tools that help people live longer, healthier, more productive lives.]]> http://www.yourlawyer.com/articles/read/10866 Wed, 26 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10866
Medtronic Inc., the nation's biggest maker of pacemakers and defibrillators, said it had received a subpoena from the U.S. attorney in Boston seeking information related to the provision of payments or other benefits to people like doctors who help decide which company's products to use.

Additionally, federal prosecutors have subpoenaed rival heart device makers St. Jude Medical Inc. and Guidant Corp., seeking documents related to implanted pacemakers and defibrillators, the companies said Tuesday.

The three medical device makers, all of which have a strong presence in the Twin Cities, said the civil subpoenas came from the U.S. attorney's office in Boston. Additionally, Guidant, in a statement, said it received a subpoena from the Minneapolis U.S. attorney's office.

Medtronic said it was asked for documents about products such as pacemakers and compliance materials related to fraud and anti-kickback statutes, the Fridley-based company said in a statement Tuesday. Little Canada-based St. Jude, ranked No. 3, said it was subpoenaed for documents on general industry practices since January 2000, according to a U.S. Securities and Exchange Commission filing earlier Tuesday.

Guidant's release said the Minneapolis subpoena requests documents relating to the company's Ventak Prizm 2 defibrillator and Contak Renewal pacemaker. Guidant is based in Indianapolis, but it develops its heart devices in Arden Hills. Guidant, the second-largest maker of heart devices, said its subpoena from the Boston U.S. Attorney's office requested documents on pacemakers and related products.

All three companies said they would cooperate with the requests. Medtronic spokesman Rob Clark and Guidant spokesman Steven Tragash didn't return phone messages to their offices after business hours. St. Jude spokeswoman Angela Craig declined to say which documents were sought. She said the subpoena was "a broad request."

Pacemakers use a mild electrical current to speed a slow heartbeat, while defibrillators jolt hearts that have life-threatening irregular beats.

In news releases, none of the companies said what prompted the subpoena, but heart devices have come under increasing scrutiny in recent months.

Dhulsini De Zoysa, an analyst with S.G. Cowen & Co., citing company management, said last month that criminal investigators for the Food and Drug Administration questioned two former Guidant employees.

Guidant recalled some of its cardiac defibrillators June 17 because of reported failures and at least two deaths. The recall involved 50,000 devices, including a model that developed flaws the company fixed in 2002. A week later, Guidant told doctors to stop using five models with another defect. No injuries or deaths were reported in that case.

On Aug. 25, the Food and Drug Administration said it was conducting comprehensive inspections of Guidant's factories. The agency said it couldn't reveal how extensive the inspections would be or how long they may take.

Last week, Medtronic said its Endeavor drug-coated stent failed to keep heart arteries open as effectively as Johnson & Johnson's Cypher in the first head-to-head U.S. study comparing the devices.

Johnson & Johnson has signaled it may seek to reduce its December offer to buy Guidant for $25.4 billion. J&J, the world's biggest maker of medical devices, has said it's considering "alternatives."]]> http://www.yourlawyer.com/articles/read/10652 Fri, 16 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10652
About 20 of every 1,000 defibrillators implanted are malfunctioning, and defects led to 31 deaths between 1990 and 2002, concluded research sponsored by the Food and Drug Administration.

The deaths represent only a fraction of the more than 400,000 defibrillators implanted during those years, but a troubling number nonetheless as regulators grapple with how to better ensure the safety of hard-to-replace devices.

Despite the defects, defibrillators "have saved many lives and the benefits of the devices clearly outweigh the risks," said Dr. Scott Gottlieb, an FDA deputy commissioner.

But, the study "does alert FDA that there is a trend that needs to be addressed, and points out the need for our agency to improve the way it regulates these products, and we are doing just that," said Dr. Daniel Schultz, FDA's medical device chief.

The study came as the FDA and cardiac specialists opened a daylong meeting Friday to discuss safety problems with implanted defibrillators and pacemakers, and how to decide which frightened patients need to have the devices surgically replaced when manufacturers learn that some parts might fail.

That can be a tough balancing act: Failures are rare, and ways to predict whose implant will fail don't always exist, while surgery to remove and replace the implant itself is risky.

But it's of growing public concern, because since January, the nation's three leading defibrillator makers: Guidant, Medtronic and St. Jude Medical  have issued recalls or safety warnings affecting more than 200,000 defibrillators.

Guidant in particular has come under fire after acknowledging that it waited three years before alerting doctors and some 24,000 patients about an electrical system defect with one of its recalled models ultimately linked to two deaths.

FDA is considering changes to the way it monitors such devices, Schultz said.

The study, conducted for FDA by Dr. William Maisel, a Harvard medical professor, found that from 1990 to 2002, there were 2.25 million pacemakers and almost 416,000 implanted cardiac defibrillators, or ICDs, implanted in the United States. More than 17,000 of them 8,834 pacemakers and 8,489 ICDs had to be surgically removed because of confirmed malfunctions, Maisel found.

These were not simple problems like battery depletion. Eighty percent were device hardware problems, such as with electrical connections.

More disconcerting than the actual number, FDA said, was the trend: In the mid-1990s, some 7.9 ICDs per 1,000 implants were replaced because of malfunctions. That rose to a high of 38.6 per 1,000 implants in 2001 before dropping slightly to a rate of 20.7 the following year.

More than half of the malfunctions occurred during the study's last three years.

In contrast, the rate of replacement for malfunctioning pacemakers steadily dropped during the study, to a low of 1.4 per 1,000 implants.

There were 30 confirmed deaths due to malfunctioning pacemakers during the 12-year period, a lower rate than for defibrillators because so many more pacemakers were implanted.

Pacemakers use mild electrical current to speed a slow heartbeat. Defibrillators use a bigger jolt of electricity on hearts that go into life-threatening irregular beats. Pacemakers have been around for decades, but only since the mid-1990s have ICDs become fairly common and these devices are becoming increasingly complex, as manufacturers make them smaller and add pacemaker features.

These likely are low estimates, FDA officials said Friday. The study tracked only surgically removed devices for which the manufacturer later confirmed a malfunction. Moreover, doctors aren't required to report malfunctions even if they suspect a patient death was due to one and not to the underlying heart disease, a sometimes difficult distinction.]]> http://www.yourlawyer.com/articles/read/10801 Sat, 10 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10801
The ICD products are within the Photon and Photon Micro device families and in certain Atlas devices.

They identified a particular vendor-supplied memory chip that can be affected at a low frequency rate by background cosmic radiation.  Background cosmic radiation bombards the earth constantly.  While the earth’s atmosphere acts as a shield and absorbs much of the cosmic radiation, some amount of high energy particles do arrive at the earth’s surface. 

When the chip is exposed to background levels of cosmic radiation, it can trigger a high current drain condition, which will deplete the battery voltage rapidly.  This can result in loss of output for a period of up to approximately 48 hours.  During this period, a patient would be without pacing or defibrillation therapy.  

The following St. Jude Medical ICDs are involved:

•    Photon DR (Model V-230HV) (certain serial numbers)
•    Photon Micro VR/DR (Models V-194/V-232)
•    Atlas VR/DR (Models V-199/V-240)

Approximately 26,000 of these devices are in service. To date, the incidence rate is low and there have been no serious patient injuries or deaths reported to St. Jude Medical attributable to this anomaly.

St. Jude Medical began using a different vendor, who utilized a different memory chip design, in 2002.  According to St. Jude Medical, laboratory testing and clinical experience indicate that the newer generation memory chip does not share the cosmic radiation problem.

St. Jude Medical notified the U.S. Food and Drug Administration (FDA) of the physician’s advisory, and the FDA may choose to recall the impacted devices.
]]> http://www.yourlawyer.com/articles/read/10106 Tue, 21 Jun 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10106
About 39,000 patients are affected by the news, although the company said no deaths or injuries have occurred as a result.

The Little Canada-based medical technology company said some models of its Atlas and Epic implantable defibrillator, or ICD, need a brief, noninvasive upgrade that can be done during an office checkup.

The news comes as rival Guidant Corp., whose cardiac rhythm management division is based in Arden Hills, deals with the fallout from a recall of 50,000 of its ICDs last week. And, earlier this year, Fridley-based Medtronic recalled 87,000 ICDs that had a battery depletion problem.

ICDs are implanted devices the size of a stopwatch that are placed in the upper chest and shock or pace an errantly beating heart back into rhythm.

St. Jude said it discovered the two "anomalies" during a routine product evaluation. They include:

• In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the patient's heart. The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. The devices on average last four to seven years before replacement.

• A second problem could cause a temporary increase in the device's pacing rate. (In addition to its shocking therapy, some patients need an ICD that can pace their heart, as well.)

The company said the software upgrade was approved by the Food and Drug Administration on Friday.

St. Jude is providing doctors with a software tool to correct the programmer, a tabletop computer that permits noninvasive communication with the implanted device.

A wand is placed on the patient's chest and the computer will determine whether the ICD is among the affected lot. If so, new software will be downloaded to the device in a procedure the company said takes 45 seconds.

St. Jude said company representatives will install the corrective software.

The affected models include: Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-239T/V-196T/V-350), Atlas DR (V-242), and Atlas Plus DR/VR/HF (V-243/V-193/V-193C/V-340/V-341/V-343).]]> http://www.yourlawyer.com/topics/overview/St_Jude_Defibrillators Tue, 21 Jun 2005 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/St_Jude_Defibrillators St. Jude Riata Defibrillator Lead Wires Perforation Problems In November 2007, reports emerged that St. Jude Riata Defibrillator Lead wires had perforated the hearts of some patients.   That month, the medical journal “Pace” published a report detailing four instances where the St. Jude Riata Defibrillator Lead wire detached and perforated the heart wall.  In one instance, the defective St. Jude Riata Defibrillator Lead wire not only perforated the heart, but it nearly poked through a patient’s skin. 

When a defibrillator lead wire becomes detached from the heart, the device will fail to emit needed electrical shocks to the heart, leaving a patient at risk of death.   If the detached St. Jude Riata Defibrillator Lead perforates the heart tissue, the heart can bleed into the pericardial sac around it.  This causes a lethal condition called cardiac tamponade in which pressure builds around the heart, preventing it from beating effectively.  In an editorial accompanying the “Pace” article, Dr. Stephen Vlay, a cardiologist for Stony Brook University, wrote that the problems with the St. Jude Riata Defibrillator Leads could be due to an “inherent design flaw, at least in some models of the Riata lead.” 

Earlier in 2007, the medical journal “Heart Rhythm” reported that the St. Jude Riata Defibrillator Lead had a higher perforation rate than what had been stated by the manufacturer.  According to that article, doctors at Massachusetts General Hospital reported a perforation rate of 3.8% - or 5 out of 130 – for the St. Jude Riata Defibrillator Lead.  Doctors from New York Hospital Queens also reported to “Heart Rhythm” that of 59 St. Jude Riata Defibrillator Leads implanted there, five had perforated.   New York Hospital Queens has since stopped using the defective St. Jude Riata Defibrillator Lead.

St. Jude Defibrillators
St. Jude Medical Inc., the maker of implantable devices that regulate heart rhythms, said it has identified a memory chip problem in a small number of some of its older devices. While no deaths or serious injuries have been reported to the company as a result of the problem, St. Jude said in a government filing that the U.S. Food and Drug Administration may classify the problem as a recall.

The problem which stems from a memory chip that St. Jude used through 2002 that is susceptible to background radiation has not been seen in any of the devices the company currently sells. The St. Jude implantable cardioverter defibrillators (ICDs) that may be affected by the radiation problem are certain older generations of the company's Photon DR, Photon Micro VR/DR and Atlas VR/DR models.

So far, only 60 out of an approximate 36,000 devices have been found to be affected, the company said in the filing. Nearly 26,000 of the devices remain in patients.

St. Jude Medical Inc. has notified doctors and federal regulators of a software problem in some models of its implantable defibrillators that could cause the heart-shocking device to malfunction. About 39,000 patients are affected by this news.

ICDs are implanted devices the size of a stopwatch that are placed in the upper chest and shock or pace an irregularer heart beat back into rhythm. St. Jude said it discovered the two "anomalies" during a routine product evaluation.

In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the patients heart. The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. The devices on average last four to seven years before replacement. A second problem could cause a temporary increase in the device's pacing rate. In addition to its shocking therapy, some patients need an ICD that can pace their heart, as well.

The affected models include: Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF(V-236/V-239/V-196/V-239T/V-239T/V-196T/V-350), Atlas DR (V-242), and Atlas Plus DR/VR/HF (V-243/V-193/V-193C/V-340/V-341/V-343).

If you or a loved one suffered injuries from a St Jude defibrillator, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>