Yourlawyer.com (Guidant Pacemakers News) http://www.yourlawyer.com/topics/overview/Guidant_Pacemakers Sat, 21 Nov 2009 18:18:55 -0800 pixel-app en Defective Guidant Defibrillators Continue to Haunt Boston Scientific http://www.yourlawyer.com/articles/read/12124 Mon, 11 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12124 recalled Guidant defibrillators. Boston Scientific purchased Guidant earlier this year for $27 billion, after outbidding Johnson & Johnson. Both companies pursued Guidant even though the company had just recalled thousands of defibrillators and pacemakers. J&J’s decision not to match the higher offer appears to have been fortuitous, as Boston Scientific has already reserved $381 million to fund Guidant related lawsuits, and some legal experts believe the company’s liability could actually be much greater.

The first trial surrounding defective Guidant defibrillators is set to begin in Corpus Christi, Texas on September 18, 2006. The plaintiffs in this are two patients who had Guidant’s Ventak Prizm 2 defibrillator implanted 2001. While both plaintiffs are still alive, they live with the fear that the devices can fail at anytime. Many patients in their same situation have elected to have the defective devices removed and replaced with new models. The removal and insertion of these devices does require risk, making it a difficult decision for patients to decide on the best course of action.

Plaintiffs argue that Guidant knew about the defects in their defibrillators for three years before they informed doctors about the problems. The defibrillator defects didn’t come to light until the death of a 21-year-old college student was reported. The student had a Guidant defibrillator implanted because he suffered from heart disease. Guidant acknowledged that the defibrillator short circuited causing his death. The company also told his doctors that it was aware of 25 other cases in which the defibrillator had been affected by the same flaw. However, Guidant’s executives said the company did not see a compelling reason to issue an alert to physicians because the unit’s failure rate was very low and replacing the devices might pose greater patient risks.

The Guidant defibrillator recall included the following models:Guidant Prizm 2 DR, Model 1861, Guidant Contak Renewal, Model H135, Guidant Contak Renewal 2, Model H155, Guidant Prizm AVT Vitality AVT Renewal 3, Guidant AVT Renewal 4 AVT, Guidant Contak Renewal 3 and 4, Guidant Renewal 3 and 4 AVT and Guidant Renewal RF.

The recalled defibrillators are known as implantable cardioverter-defibrillators or ICD’s. These devices are implanted under the skin of patients to manage sudden cardiac death due to ventricular fibrillation. ICD’s are used to treat patients at risk of recurrent, sustained ventricular tachycardia or fibrillation. When an ICD detects ventricular tachycardia or fibrillation, it shocks the heart to restore the normal rhythm. When working properly, ICD’s have been very useful in preventing sudden death in patients with known, sustained ventricular tachycardia or fibrillation. New studies are being conducted to learn if ICD’s can be used to prevent cardiac arrest in high-risk patients who haven’t had, but are at risk for, life-threatening ventricular arrhythmias.

www.newsinferno.com

]]> FDA Update Statement On Boston Scientific/Guidant Pacemakers And Defibrillators http://www.yourlawyer.com/articles/read/11984 Mon, 17 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11984
"While information about the problem with these devices is still very preliminary, FDA is committed to keeping the public informed," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. "We support Guidant's decision to notify physicians and hospitals early in the investigation, and we believe that retrieval of non-implanted devices is a prudent first step. Analysis of returned devices may uncover clues that will allow Guidant to make further recommendations to physicians regarding patient care. Early public notification was one of the important recommendations that emerged from last fall's meeting of the Heart Rhythm Society."

Boston Scientific/Guidant has confirmed five reports of device malfunction among some 27,200 patients worldwide in whom these devices were implanted. One malfunction occurred at the time of implantation. In four cases, the patients needed to have the device replaced. The patients lost consciousness in two of these cases. There are no reported deaths.

Boston Scientific/Guidant has identified certain lots of a supplier's low-voltage capacitor as the likely source of the problem. The affected products include certain models of the Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators. These devices were manufactured by the company's Cardiac Rhythm Management Group, formerly Boston Scientific/Guidant's CRM business, and implanted in patients between December 2005 and June 2006. For more information, a letter to both patients and physicians regarding this notification is available at guidant.com/physician_communications.

Boston Scientific/Guidant is actively investigating the capacitor failure to determine the cause, the rate of occurrence, and the time to failure. Over the next 60 days, the company's engineers will be testing the retrieved devices and analyzing the results. The company will communicate its findings to the FDA and physicians as soon as they are available.

In the meantime, as a cautionary step, Boston Scientific/Guidant has notified physicians to schedule appointments with patients implanted with affected devices as soon as possible. Physicians should examine the patient to identify any problems and to obtain information concerning when and under what circumstances these devices may fail.

"We encourage patients who have been contacted by their physicians because they may have one of the affected devices to follow their recommendation and make an appointment to have the device checked as soon as possible," Dr. Schultz said.

"The Heart Rhythm Society applauds this proactive, collaborative effort to inform patients and physicians about the most recent device notifications. This is a monumental step in providing optimal patient care and is based on the Society's draft recommendations released in April," said Anne B. Curtis, M.D., FHRS, Immediate Past President, Heart Rhythm Society. "We believe the most important step is for patients to contact their heart rhythm specialist to determine the best course of action."

FDA is interested in receiving information about problems with any devices and encourages hospitals and the public to submit reports directly to MedWatch, the FDA's voluntary reporting program. Reports may also be submitted by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.]]> Boston Scientific Announces Physician Communication Related to Products in Its CRM Group http://www.yourlawyer.com/articles/read/11923 Mon, 26 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11923 Paul Donovan
508-650-8541

Boston Scientific Corporation (NYSE: BSX) today announced that it is providing safety information and retrieving a specific subset of pacemakers, cardiac resynchronization pacemakers and implantable cardioverter defibrillators from its sales force and hospital inventories. The specific subset of devices includes INSIGNIA and NEXUS pacemakers, CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM 2, VITALITY, and VITALITY 2 implantable cardioverter defibrillators. These products are manufactured by the Company's Cardiac Rhythm Management (CRM) Group, formerly Guidant's CRM business. Boston Scientific acquired Guidant on April 21.

Boston Scientific CRM has recently identified a supplier's low-voltage capacitor that is not performing to the company's expectations. A capacitor is an electrical charge storage component. Some capacitors from specific lots may perform in a manner that leads to device malfunction, including intermittent or permanent loss of therapy or premature battery depletion. To date, a total of five confirmed events have been reported out of approximately 27,200 implanted devices from this subset. One event involved a device malfunction discovered at the time of implant. The other four events involved devices that were implanted and subsequently required replacement.

Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry, or premature battery depletion. Patients with affected defibrillators may experience inappropriate sensing or premature battery depletion. There have been no reported patient deaths associated with this issue. There have been two reports of pacemaker patients experiencing syncope associated with loss of pacing output.

Engineering analysis is ongoing and the company will further communicate on this issue when it has additional information. Implanting and following physicians are being asked to schedule an in-clinic follow-up visit as soon as possible for all patients with implanted devices from this subset to assess device function. At this follow-up visit, physicians should look for behaviors that may be indicative of capacitor malfunction such as premature battery depletion, intermittent or permanent loss of therapy or telemetry, fault codes, pacing or sensing abnormalities, or loss of daily measurements.

"Boston Scientific believes in notifying physicians in a timely, transparent and responsible manner," said Jim Tobin, Boston Scientific President and Chief Executive Officer. "This action reflects Boston Scientific's industry-leading commitment to implementing recommendations made by both the Heart Rhythm Society and the Independent Panel Commission chaired by Dr Robert Myerberg. Boston Scientific is the only CRM company that has committed to implementing these recommendations, which it believes are in the best interest of patients and physicians."

Physician communications can be viewed in their entirety at http://www.guidant.com/physician_communications/.
]]> Studies show implanted heart device can malfunction, but removal's risky http://www.yourlawyer.com/articles/read/11607 Wed, 26 Apr 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11607
Compared with pacemakers, which are simpler and serve a different purpose, implantable defibrillators are five to 20 times more likely to malfunction and need replacement.

At the same time, people who learn that the device implanted in their chest may have a defect should think hard before having it replaced. Switching it out may be more risky than leaving it in.

Those are among the conclusions of three studies being published today in the Journal of the American Medical Association that shed light on the hazards of implantable cardioverter-defibrillators (ICDs), perhaps the hottest medical device of the past decade.

The number of ICDs implanted in Americans has more than tripled from about 54,000 in 1999 to 168,000 last year. Sales are increasing 15 to 18 percent a year and are expected to continue rising as the population ages and the number of medical conditions shown to benefit from ICD use grows.

An ICD is sometimes likened to having a miniature ambulance crew inside the chest. The device can detect an abnormal heart rhythm, determine whether it can be ``converted'' to a normal rhythm with a shock and then deliver the jolt if the answer is yes, and it keeps a record of what it has done.

The devices cost about $20,000. The implantation procedure costs about $10,000 in physician and hospital charges.

The wires that deliver the life-saving shocks are snaked into the heart through a vein and then attached to an electronic box, smaller than a pack of cards, placed under the skin of the upper chest. The procedure requires no open-heart surgery and usually is done by a cardiologist.

The new studies did not address the value of ICDs. Everyone involved agreed the devices constitute a big advance in therapy that has saved the lives of tens of thousands of people who otherwise might have died while waiting for a handheld defibrillator to arrive.

Pacemakers are used primarily to speed up the heartbeat. They deliver short, low-power pulses, not shocks, are less complicated than ICDs and have been in use longer.

Two of the studies were headed by William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston. After a study he did suggested that malfunction rates for ICDs were rising, the Food and Drug Administration, which licenses the devices, asked him to study the issue further.

Maisel and his collaborators examined device-makers' reports of ICD and pacemaker malfunctions for the years 1990 through 2002. They calculated the number of ICDs and pacemakers that malfunctioned and were replaced per 1,000 of the devices implanted each year. (This does not represent an individual's chances of getting a defective device.)

For pacemakers, the malfunction rate declined from 9 per 1,000 implantations in 1993 to 1.4 per 1,000 in 2002. For ICDs, it fell from 39 per 1,000 implantations in 1993 to 8 in 1996, but then rose to 36 per 1,000 in 2002.

A study of three registries of ICD and pacemaker implantations -- in North America, Denmark and Britain found the same trend but extended it longer and found a marked decline in malfunctions from 2002 through 2004.

A trade organization for device-makers, the Advanced Medical Technology Association, said its records show the malfunction rate for ICDs last year was about 1 per 1,000 implanted -- and that about half the problems would simply delay a shock by several seconds.

In the third study, Andrew Krahn, a cardiologist at the University of Western Ontario, examined the rate of complications in people who were told their ICD might have a chance of failing.

In 17 Canadian hospitals over a one-year period, 2,915 patients received such a notice, and 533 (18 percent) decided to get the devices replaced. Of them, 31 (6 percent) had complications and two died. During that year, only three malfunctions occurred in the devices for which ``advisories'' had been issued. None of those resulted in death or serious illness.
]]> Replacing Heart Device Found Risky http://www.yourlawyer.com/articles/read/11600 Wed, 26 Apr 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11600 Surgery to replace potentially defective heart defibrillators carries an unexpectedly high rate of serious complications, including death, according to a study published today. 

The research in the Journal of the American Medical Assn. showed that one in 50 patients needed to have the replacement device removed because of severe postoperative infections.

Dr. Andrew D. Krahn of Canada's University of Western Ontario and one of the study's authors said the overall complication rate was three to five times higher than expected. "We were absolutely surprised by these numbers," he said.

Two other studies in the journal tracked the annual malfunction rate of defibrillators, which started rising in the late 1990s as the devices became more complex but began falling in 2002. It is now less than 1%.

Taken together, the three studies paint the fullest picture yet of the risks to patients of removing or retaining a defibrillator recalled by its manufacturer.

The reports come amid controversy about defibrillators, devices used to steady heartbeats or jolt the hearts of those in cardiac arrest.

Medtronic Inc. and Guidant Corp. last year issued warnings about flaws in their defibrillators.

Guidant also faces a Justice Department inquiry related to its safety alerts. The company told the Food and Drug Administration about electrical problems with its Ventak Prizm 2 DR device but did not give that information to patients and doctors.

About 135,000 patients receive a defibrillator each year to help prevent a sudden heart attack. The devices differ from pacemakers, which are older, less complex devices that use tiny currents of electricity to regulate slow heartbeats.

Krahn said doctors had long believed the complication rate for defibrillator surgery ranged from 1% to 2%, about the same as for routine operations.

But his study of 533 patients at 17 Canadian medical centers who elected to have their defibrillators replaced after a safety recall found that 43 patients, or 8.1% of the total, suffered infections and other complications within three months of their surgeries. Of those, 31 patients, or 5.8%, had severe complications and two died. Ten patients with bad infections needed to have replacement devices removed.

The study was the first to examine the rate of complications associated with replacing defibrillators, a procedure typically performed every five to seven years to replace batteries.

Krahn couldn't explain why the complication rate was so high. The study suggests patients and their doctors should weigh the risks of complications before removing defibrillators after a safety alert, he said.

"When you start changing out a device with a risk of problems well under 1%, you could be causing more complications than you are saving," said Dr. Anne B. Curtis, president of the Heart Rhythm Society and a University of South Florida professor.

The second study examined cases of malfunctions requiring replacement that were reported to the FDA from 1990 to 2002. Researchers found that as the devices became smaller and more complex, the malfunction rate rose to a peak of 36.4 per 1,000 in 2001, or nearly 4%, from a low of 7.9 per 1,000 in 1996, less than 1%.

The average malfunction rate of defibrillators during the 12 years of the study was more than four times that of pacemakers over the same period. Results of the study, conducted by Dr. William H. Maisel of Beth Israel Deaconess Medical Center in Boston and researchers from the FDA, were first reported at a medical meeting in September.

The third study, conducted by Maisel, looked at malfunctions reported to patient registries in the United States and Demark from 1988 to 2004. As in the FDA study, the malfunction rate peaked in 2001 but fell to 7.4 per 1,000 in 2004, less than 1%.

Although the drop was encouraging, Maisel said, defibrillators were not as reliable as pacemakers, which had a malfunction rate of 1.3 per 1,000 in 2004. He said patients with the devices should be monitored.

]]> Risk cited in replacing heart device http://www.yourlawyer.com/articles/read/11601 Tue, 25 Apr 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11601
Canadian researchers found a much higher than expected rate of surgical complications in people who had their potentially faulty defibrillators replaced.

As a result, some patients "might want to hang out and wait and see what happens," said study co-author Dr. Andrew Krahn of the London Health Sciences Center in Ontario.

Six percent of the 533 patients who decided to have their recalled defibrillators replaced over a 12-month period suffered major complications, including two deaths, the study found.

In contrast, the risk of failure among recently recalled defibrillators has been estimated by the manufacturers at just 0.009 percent to 2.6 percent. And not every failure is deadly.

The study, published in Wednesday's Journal of the American Medical Association, provides the first estimate of the risk of major complications from replacement surgery. That is important information for patients and doctors faced with the decision of whether to leave a possibly defective device in the body or replace it.

Implantable defibrillators can be as small as a half dollar and are placed surgically under the skin of the upper chest. Vice President Dick Cheney is among the thousands of Americans who have one.

When the device senses a dangerous and potentially deadly irregular heartbeat, it sends electrical impulses to jolt the heart back to normal. It can correct a heart that beats too fast, as in ventricular tachycardia, or quivers chaotically, a condition known as ventricular fibrillation.

A total of 270,000 defibrillators have been recalled since January 2005, though it is unclear how many were inside patients and how many were on the shelf, according to the Food and Drug Administration. About 80,000 patients received the implantable devices in 2004.

Krahn said the rate of complications from surgical removal will surprise doctors, because replacing a defibrillator is considered a minor procedure.

"It's typically performed with a local anesthetic and sedation. It takes an hour or less," he said. "Most patients return home the same day."

The researchers studied 2,915 patients who were tracked by 17 Canadian hospitals in 2004-05. All the patients had devices that were recalled by manufacturers, Canada's national health system or the FDA.

Only 18 percent decided to undergo replacement surgery. Infection, bruising or bleeding required a follow-up operation in 31 of those patients. Two patients died.

"That risk is much higher than we initially thought," Krahn said.

The researchers did not follow the people who decided against replacement to see whether anything actually went wrong with their defibrillators.

The findings are applicable to the U.S. because American medical practices are similar to those in Canada, Krahn said.

"We probably should leave more of these alone if they appear to be functioning normally," said Dr. Anne Curtis, president of the Heart Rhythm Society, a nonprofit group of heart specialists, and chief of cardiology at the University of South Florida. Curtis was not involved in the study.

The Heart Rhythm Society plans to release draft recommendations Wednesday on pacemakers and implantable defibrillators. The draft will include guidelines to help doctors respond to recalls, Curtis said.

Implantable defibrillators, which cost between $30,000 and $40,000, contain batteries, insulated wires, memory chips, magnetic switches and other parts that can go awry. But some flaws are worse than others.

While some people might die because the device doesn't deliver the necessary shock, other devices might have a flaw that merely causes the battery to run down early, something that can be caught during routine monitoring.

And some people who have defibrillators don't need them as much as other patients do. Some patients are implanted with the devices as a preventive measure and have never actually suffered from fibrillation.

Doctors and patients often decide to leave a potentially faulty device in place after weighing the details of the recall and the patient's health. Krahn said some patients may decide they cannot risk a device failure, and may go ahead with replacement surgery.

Dr. Dan Schultz, director of the FDA's Center for Devices and Radiological Health, praised the study.

"This will allow the agency, as well as manufacturers and professional societies, to develop guidelines based on actual evidence, and to provide better advice to patients and doctors in the future," Schultz said.

After a recall, manufacturers provide free replacements. But insurance companies must pay for the surgery, which can cost thousands of dollars.

Krahn reported that he has financial ties to two device makers, Medtronic and Guidant. But he said that the study was conducted without funding or influence from industry, and that his consulting work does not involve the defibrillators.
]]> Guidant Updates Worldwide Physician Communication Regarding Important Safety Information About Certain Pacemakers http://www.yourlawyer.com/articles/read/11196 Mon, 23 Jan 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11196
July 18, 2005 Advisory Population Update

On July 18, 2005, Guidant informed physicians about the potential unintended device behaviors in a subset of the following devices:

PULSAR(R) MAX                            DISCOVERY II
PULSAR                                   VIRTUS PLUS(R) II
DISCOVERY(R)                             INTELIS II
MERIDIAN(R)                              CONTAK(R) TR
PULSAR MAX II

A hermetic sealing component utilized in 78,000 devices manufactured between October 27, 1997 and October 26, 2000 may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life. This can result in serious health consequences as discussed in the July 18, 2005 physician letter. The U.S. Food and Drug Administration (FDA) classified the July 18, 2005 communication as a Class I recall. These products have not been sold or implanted for the last four years.

As of January 9, 2006, there have been a total of 145 reported incidents, which represents a rate of occurrence of 0.19%. It is estimated that 16,000 devices in this advisory population remain implanted worldwide. Guidant's projected rate of occurrence for reported events within the remaining lifetime of active devices is now estimated to be between 0.31% and 0.88%, which has increased from the July 18, 2005 estimate of between 0.17% and 0.51%. Guidant's original patient management recommendations remain unchanged. Guidant recommends that physicians reassess their patients in light of the increased projected rate of occurrence.

Second Population

Since July 18, 2005, Guidant has identified a second population of 54,000 devices manufactured between October 19, 1998 and December 5, 2000 that are at risk of hermetic seal degradation, though at a much lower rate than the advisory population. At the time devices in the second population were assembled, hermetic sealing components susceptible to gradual degradation were mistakenly mixed with a much larger group of non-susceptible components. Within the second population of 54,000 devices, Guidant has identified by model number and date-of-manufacture approximately 2,500 devices with susceptible components, but is unable to identify susceptible devices by serial number.

Guidant has communicated this information to regulatory agencies worldwide. The FDA has indicated that it may consider this communication as an expansion of the original Class I recall.

As of January 9, 2006, a total of five reported incidents out of 54,000 represents a rate of occurrence of 0.009%. Guidant has confirmed hermetic seal degradation in two of the five reports. It is estimated that 19,300 devices in this second population remain implanted worldwide.

If a device in the second population has a susceptible component, it is subject to a risk of hermetic seal degradation equal to that of the original population. However, because devices with a susceptible component cannot be specifically identified and are distributed among the 54,000 devices in the second population, the projected rate of occurrence for reported events within the second population is substantially lower than the projected rate of occurrence for the original advisory population. For the remaining lifetime of active devices, the projected rate of occurrence for reported events within the second population is estimated to be between 0.02% and 0.06%. Physicians should consider the much lower projected rate of occurrence and the needs of each individual patient, including pacemaker dependency, when making patient management decisions for patients in the second population.

Guidant's warranty supplement program, subject to certain conditions, provides a no cost replacement device and up to $2,500 in unreimbursed medical expenses. The program is available through June 30, 2006 and is applicable to both populations.

Patient safety is Guidant's primary concern, for additional information contact 1-866-GUIDANT (1-866-484-3268) (24/7) and http://www.guidant.com/physician_communications.]]> Guidant Gets FDA Warning Letter on Facility http://www.yourlawyer.com/articles/read/11103 Tue, 27 Dec 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11103
Guidant said the warning, which comes from the Food and Drug Administration, is for the company's manufacturing, research and sales center in St. Paul. The FDA finished an inspection of the center, known as the company's Cardiac Rhythm Management facility, in September.

Guidant received the FDA's warning letter last Friday. The letter indicates that the FDA won't grant any of the company's requests for exportation certificates to foreign governments, or approve the company's applications for certain medical devices until Guidant takes steps to resolve the agency's concerns.

Guidant said it has thoroughly reviewed its St. Paul system and has made substantial steps toward addressing all the FDA's observations that prompted the warning letter. The company also said it believes it can fully address the FDA's concerns without seriously affecting its business.

The company disclosed in September that the FDA had raised some concerns about its St. Paul operations. The company said at the time that it planned to improve its product labeling and provide more frequent and detailed product performance reports, but Guidant hadn't yet received a response from the FDA.
]]> Report: Guidant knew of device's faults http://www.yourlawyer.com/articles/read/11088 Sat, 24 Dec 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11088
The Indianapolis-based company filed papers in a Texas court indicating officials were aware in 2002 that the consequences of the defibrillator's electrical failure were rare, but could be "life threatening." Despite that assessment, Guidant kept selling potentially flawed devices and did not notify doctors about the defect until last spring, when the problem was about to be made public by the Times, the newspaper said.

At least seven people have died because of the flaw, and Guidant has since recalled 80,000 implantable defibrillators in June. In September, Guidant recalled 380,000 pacemakers.

A chart on the document submitted to the court shows the company's acceptable failure rate was about 15 devices a year, a rate of slightly more than one a month.

"For Guidant, these people are numbers," said Dr. William Maisel, chairman of the Food and Drug Administration advisory committee that reviews heart devices. "Their descriptions are full of numbers. But for me, these patients are people."
]]> Guidants Troubles Continue to Grow http://www.yourlawyer.com/articles/read/10750 Thu, 29 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10750
The FDA has been looking more closely at Guidant’s products, and recently completed an inspection of the company’s St. Paul, Minnesota Cardiac Rhythm Management facility.  That inspection led to a Class I recall of some of Guidant’s best-selling pacemakers. 

One aspect of interest to the FDA is whether Guidant properly reported device failures and manufacturing changes.  Executives of Guidant maintain that they properly reported all issues to the FDA.

FDA spokeswoman, Julie Zawisza, told the Times that the agency does not confirm or deny ongoing investigations, and a spokesman for Guidant, Steven Tragash, told the newspaper that he was not aware that the company had been contacted.  He added that the company was aware that some former employees had been contacted by the FDA.

Once the FDA completes its investigation, it can choose to forward its findings to the Justice Department, which can take a number of actions, including bringing civil or criminal charges against the company.

The FDA investigation is not Guidant’s only problem.   Both the New York Times and the Wall Street Journal reported on Tuesday that Guidant had paid doctors to implant its medical devices.  The Times said that Guidant had paid physicians $1,000 for implanting an improved electrical component, called a lead, into three patients.

Guidant stated that they ran programs like the electrical lead evaluation so they could improve future models.  However, according to the Times, critics of the industry have long charged that some companies use research studies to mask what are really marketing efforts.

The Times editorial page also weighed in on the issue of physician ties to medical device makers, stating that “many surgeons have ties to manufacturers, ties that are often not revealed to their patients or to hospitals.”  The editorial went on to say that while doctors maintain they need close relationships with manufacturers so they can help perfect medical devices, there are several ongoing investigations to determine if these consulting arrangements are in fact “unethical and unlawful payoffs for using the devices."]]> FDA Study Shows Defibrillator Malfunctions are on the Rise http://www.yourlawyer.com/articles/read/10683 Mon, 26 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10683
The findings were presented at the Heart Rhythm Society “Policy Conference on Pacemaker and ICD Performance” in Washington, DC.

The study found that thousands of patients were affected by PM and ICD malfunctions during the 12-year period, and that malfunctions were directly responsible for 61 confirmed deaths.   While the study found a decrease over time in the annual number of malfunctioning pacemakers that were removed and replaced in patients (4.6 per thousand), there was an increase in the number of malfunctioning ICDs (20.7 per thousand), especially during the last three years of the study, when more than 50% of the reported malfunctions occurred.

Potential reasons for the increase in ICD malfunctions include the increased complexity of the ICD devices, manufacturing challenges posed by this complexity, and increased reporting by physicians.  The authors stated that ICDs are a rapidly changing technology.  Over the past 10 years, ICDs have shrunk in size, provided more therapeutic features, and increased their memory.  The decrease in size has brought modifications to battery, capacitor, and circuitry design that may account for some of the malfunctions.

The study also concluded that careful monitoring of device performance is needed.  That may include requesting more detailed information from manufacturers before the devices are approved for marketing and while they are in use by the clinical community.  Another important step is finding ways to communicate more effectively with physicians and patients when the devices malfunction. 

“The FDA is committed to continuing to improve the quality of information that patients and doctors have to make decisions about the safe and effective use of these critical, life-saving technologies,” said Scott Gottlieb, MD, FDA Deputy Commissioner for Scientific and Medical Affairs.  “Pacemakers and ICDs have saved many lives and the benefits of the devices clearly outweigh the risks.  All sophisticated medical devices like these have certain risks.  Our challenge remains to uncover these risks, measure them, and make information available to patients and doctors to help guide their personalized decisions about where the benefits of technologies like these outweigh known or potential risks from their use.”

In preparing this report, the FDA reviewed 366 PMA annual reports, covering hundreds of pacemaker and ICD models.  In light of the findings, the FDA is considering doing analyses like this for ICDs and pacemakers on a periodic basis, so they can monitor the malfunction trends.

The FDA is also taking other steps to address the troubling information found in their report.  They have begun to better coordinate their pre and post-market regulation of the devices, insuring that products are closely monitored after they are in clinical use.  They are also considering asking manufacturers for more comprehensive data, and they are exploring ways to better communicate with physicians and patients.

The FDA has also established a defibrillator working group which is exploring the best way the FDA can make information about defibrillator recalls available to physicians and patients.   

The FDA stressed that the vast majority of reported malfunctions did not lead to death or serious injury, and were detected in time to ensure that patients would continue to receive therapy when it was needed.

“It is important for patients to understand that there is no action that they need to take as a result of this report.  It does alert FDA that there is a trend that needs to be addressed and points out the need for the agency to improve the way it regulates these products, and we are doing just that,” said Daniel Schultz, MD, Director of FDA’s Center for Devices and Radiological Health (CDRH).

The FDA has the following top-priority actions underway:

·Increasing CDRH’s ability to obtain critical information about medical device failures so they can communicate this information clearly and rapidly to both physicians and patients, allowing them to make informed medical decisions.

·For ICDs in particular, the formation of a working group so information can be quickly reviewed and evaluated by staff, and shared more rapidly with the public.

·Operational changes in CDRH’s post-market program to track the performance of medical devices once they each the market and are in general use.  These changes include targeting resources to inspect firms that manufacture potentially higher risk devices, the design of an electronic system for adverse event reporting, and developing guidance for companies to insure that annual reports provide the types of information required for prompt and efficient review by the FDA.]]> Guidant Issues Fifth Product Recall This Year http://www.yourlawyer.com/articles/read/10675 Fri, 23 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10675
Failures may result in an intermittent or permanent loss of pacing or telemetry, or the appearance of a reset warning message.  According to Guidant, these failure modes can result in serious health complications.  Although no known deaths have resulted from the failures, hospitalizations have occurred, and the company urged patients to consult with their doctors.

This recall affects over 50% of the company’s pacemaker products, and was due to a report issued by the FDA that included trend observations on the Insignia and Nexus pacemaker families.  The report was filed when the FDA completed its most recent inspection of Guidant’s Cardiac Rhythm Management facilities in St. Paul, Minnesota.  According to the FDA, a seal within the pacemaker devices can leak, allowing moisture to affect the electronic circuits.  The problem can occur without warning and can lead to loss of consciousness, and possibly heart failure and death.

The following pacemaker models are affected by the Guidant recall.  They were all manufactured between November 25, 1997 and October 26, 2000:

·    PULSAR MAX Models 1170, 1171, 1270
·    PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
·    DISCOVERY Models 1174, 1175, 1273, 1274, 1275
·    MERIDIAN Models 0476, 0976, 1176, 1276
·    PULSAR MAX II Models 1180, 1181, 1280
·    DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
·    CONTAK TR Model 1241
·    VIRTUS PLUS II Models 1380, 1480
·    INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

The FDA has classified Guidant’s recall as a Class I recall, meaning that there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.

While the failures can occur without warning, sometimes a malfunction can be detected by a physician before it causes serious problems.  Guidant has provided information to physicians about ways to identify a leak-related malfunction.  However, Guidant is not aware of any test that will show if a normally functioning pacemaker is likely to fail in the future.

As of July 11, 2005, Guidant had received reports that 69 pacemakers may have failed due to the leakage.  Approximately 18,000 of the affected devices remain in service in the United States and an additional 10,000 are in service in other countries.

This recall follows the June 17th, 2005 recall of 50,000 Guidant Implantable Cardiac Defibrillators, due to faulty insulation in the wiring.  Defibrillators, used primarily by people who suffer from arrhythmia or an irregular heartbeat, are designed to electrically stimulate the heart.  Guidant announced a second defibrillator recall on July 19th, affecting over 25,000 patients.

Joint research done by the Food and Drug Administration and Harvard Medical School, indicates that the number of defects in implantable defibrillators is rising quickly.  According to William Maisel of Harvard Medical School, it is the recent increase of faulty devices that is troubling. More than half of the defects throughout their 12-year study occurred within the last three years. 

According to the study, defibrillator replacements due to these defects has not kept pace with the recalls, indicating that more needs to be done to assist patients and doctors in the replacement of the faulty and life-threatening devices.

Congress is also taking a hard look at Guidant and how the FDA is monitoring the recalls.  Senator Charles E. Grassley, Chairman of the Senate Finance Committee, has requested information from the FDA concerning the faulty defibrillators.  In his letter of July 20th, he cites the death of a young college student whose implantable defibrillator failed due to a short circuit.

Joshua Oukrop, a 21-year-old student who suffered from a genetic heart disease, died earlier this year when his Guidant Prizm 2 defibrillator short-circuited while he was biking.  A month later, Guidant began notifying doctors of the electrical flaw.

Senator Grassley requested post-approval reports for the recalled heart devices and an update on the steps the FDA and Guidant are taking to establish guidelines for device surveillance and the dissemination of information to both physicians and patients.

Grassley has long been an advocate of dissemination of post-approval information on drugs and their possible harmful side effects.  He and Senator Christopher Dodd (D-Conn) have introduced legislation that would create a national data bank of clinical information, and have written a bill which would establish an independent drug safety office within the FDA.  This office would regulate drugs once they are on the market.

It is not clear if Senator Grassley will call for hearings on Guidant’s recalls, but his staff left the door open for that possibility.]]> Health Canada Advises Canadians About Risks Associated With Guidant Pacemakers http://www.yourlawyer.com/articles/read/10419 Thu, 04 Aug 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10419
This may lead to premature battery depletion and malfunction of the pacemakers. Health Canada was informed of the recall of these devices by the manufacturer on July 15, 2005.

The affected pacemakers were manufactured between November 25, 1997 and October 26, 2000. Guidant reports that there are 1,622 of these devices in service in Canada. The company has issued a letter to physicians informing them of the need to monitor their patients and take appropriate action based on the unique needs of each patient.

Patients with one of these pacemakers are advised to consult with their physicians regarding any risks to their health. Patients should seek immediate medical attention if they notice a prolonged rapid heart rate, lightheadedness, or have new or increased symptoms of heart failure such as shortness of breath, fatigue, confusion or nausea.

Health Canada was informed of this issue by the manufacturer on July 15, 2005. Health Canada is aware of one non-fatal device failure in Canada associated with the recent Guidant action and continues to monitor the effectiveness of the recall of these products. Approximately 28,000 of these pacemakers remain implanted worldwide. Fifty-two cases of malfunction have been confirmed worldwide. Health Canada is not aware of any deaths associated with the malfunctioning of these pacemakers.]]> Guidant May Face Senate Scrutiny http://www.yourlawyer.com/articles/read/10347 Sun, 31 Jul 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10347
Though a big-money business, defibrillators and pacemakers hardly seem the purview of one of Congress' most powerful bodies.

But no one in the medical technology industry was terribly surprised this month when Sen. Charles Grassley asked the Food and Drug Administration (FDA) for documents relating to the recent recall of some 150,000 heart defibrillators and pacemakers.

As Grassley pointed out in two recent letters to FDA Commissioner Lester Crawford, his committee has jurisdiction over Medicare and Medicaid programs, which provides health insurance for more than 80 million Americans and often pays for the sophisticated devices.

In the past year, Grassley, 72 and a farmer by trade, has emerged an ardent critic of the FDA, which regulates the drugs and devices approved for use in the United States.

The Iowa Republican began conducting oversight of the embattled regulatory agency after concerns surfaced about how it handled the suicide risks of teenagers using antidepressants and the cardiovascular risks associated with the painkiller Vioxx.

Now Grassley has requested copies of annual post-approval reports for the models of defibrillators and pacemakers that were the subject of Guidant safety alerts in recent weeks. These reports, he said, are not available to the public, even though they might contain important performance data about the devices.

He asked Crawford to explain why these reports are not posted on the FDA's website, and whether the agency is reconsidering procedures for surveillance of devices once they're approved and widely available to the public.

Indianapolis-based Guidant, which makes its heart devices in Arden Hills, came under fire after the death in March of a 21-year-old Grand Rapids college student, Joshua Oukrop, whose heart condition was treated in 2001 with one of the company's defibrillators. It was subsequently revealed that his model of defibrillator had an electrical flaw that was remedied in 2002 action that was reported to the FDA.

However, neither Oukrop nor his doctors were told that he was implanted with a potentially faulty device until it was too late. Other physicians and patients were not notified until May of this year when his doctors went public with their concerns about the device.

The controversy raises questions about when doctors should be told about device malfunctions, and to what extent. Fred McCoy, president of Guidant's cardiac rhythm management business, said this week that it's clear doctors want more information and that the company is more than willing to provide it.

Asked specifically about Grassley's questions for the FDA, McCoy said in an interview that "Guidant is an open book. We'll follow that process wherever it leads, it's certainly not something we're concerned about."

Grassley also asked Crawford to describe the agency's disclosure policy regarding post-approval documents for devices not only for defibrillators and pacemakers, but for all devices.

The dissemination of post-approval information about drugs and possible harmful side effects has long concerned the senator. He declined, through a spokeswoman, to be interviewed.

"The job for Congress, the FDA and consumer advocates is to get to the bottom of drug safety procedures and figure out, once and for all, what it'll take to make sure Americans can trust what's in our medicine cabinets," Grassley said in a speech to the Consumer Federation of America last March.

"Better-informed patients and doctors can make informed decisions about whether a drug is right for them," he said.

Grassley has also questioned whether the FDA is too cozy with the pharmaceutical industry, and has called for changes that he says would bring greater responsiveness and transparency to the agency.

In that vein, Grassley and Sen. Christopher Dodd, D-Conn., have introduced legislation creating a publicly accessible national data bank of clinical trial information. In addition, the two have introduced a measure to establish an independent office for drug safety within the FDA that would regulate drugs once they're on the market. Both bills are pending.

Grassley's efforts have gained support from several consumer groups including Ralph Nader's Public Citizen, which has battled the FDA for decades.

"The FDA is getting direct cash, over $200 million a year, from industries [it regulates] and it has a very detrimental effect of the ability of the FDA to protect the public," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

Whether Grassley's recent request for device-related documents will result in committee hearings or legislation is unclear at this point. His spokeswoman said a decision about whether hearings will be held "will be made as the process unfolds."

Wolfe supports the idea of a public forum to discuss these issues. "I'm sure there are a lot more things that the FDA knows or that the company knows about the Guidant or many of these other disasters that would only come out if there's a public hearing where pointed questions were asked and the people answering them fearing perjury if they lied or gave incomplete answers," he said.

An FDA spokeswoman said Friday that the agency would "carefully consider" Grassley's request.]]> Parker & Waichman, LLP Investigating Claims of Victims Injured by Recently Recalled Guidant Pacemakers http://www.yourlawyer.com/articles/read/10321 Fri, 22 Jul 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10321
The FDA issued a press release earlier today announcing a Class I recall of the Guidant pacemakers. A Class I recall is the most serious recall that the FDA can issue and indicates a strong likelihood that the defective product can cause serious injury or death. All of the recalled pacemakers were manufactured between November 25, 1997 and October 26, 2000. Guidant has said that 78,000 of these pacemakers were originally distributed and that approximately 18,000 devices remain implanted in patients in the United States today. The company also warned that the likelihood of injury or death increases with time since implant and urged patients to visit their physicians as soon as possible.

The defective pacemaker models are listed below:
  --  PULSAR(r) MAX Models 1170, 1171, 1270
  --  PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
  --  DISCOVERY(r) Models 1174, 1175, 1273, 1274, 1275
  --  MERIDIAN(r) Models 0476, 0976, 1176, 1276
  --  PULSAR MAX II Models 1180, 1181, 1280
  --  DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283,
      1284, 1285, 1286
  --  CONTAK TR(r) Model 1241
  --  VIRTUS PLUS(r) II* Models 1380, 1480
  --  INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

The failure of the pacemaker to provide pacing output can cause sudden faintness or loss of consciousness and can result in death. The leakage defect can also cause a sustained rapid heart rate, which can cause heart failure and result in death. As of July 11, 2005, Guidant had received sixty-nine reports of pacemakers that may have failed because of the leakage. Twenty of these pacemakers were confirmed to have stopped providing pacing output, resulting in loss of consciousness in five patients. Guidant also received reports of two patients who had sustained pacing at a rapid rate; one patient was admitted to the hospital and later died. Unfortunately, there is no way to test if a pacemaker is defective or not, and the removal and replacement of a device can carry serious health risks.

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide, with offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. For more information on Parker & Waichman, LLP please visit: (http://www.yourlawyer.com) or call 1-800-LAW-INFO (1-800-529-4636).

CONTACT:  Parker & Waichman, LLP
          David Krangle, Esq.
          1 (800) LAW-INFO (800-529-4636) (toll free)
          dkrangle@yourlawyer.com
          http://www.yourlawyer.com]]> Guidant Issues Warning for 28,000 Pacemakers http://www.yourlawyer.com/articles/read/10253 Mon, 18 Jul 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10253
The Indianapolis-based company, which last month recalled almost 109,000 defibrillators, released a warning that says a sealing component in the pacemakers has degraded in some cases, resulting in higher-than-normal moisture in the devices and possible malfunction.

The company said about 78,000 of the devices were distributed, with about 18,000 of them remaining in U.S. patients.

Guidant said that it has identified 69 failures among the pacemakers - all after they had been used for at least 44 months. The models include: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, and Contak TR.

The company told physicians they should consider replacing the pacemakers for patients who are dependent on the devices, which send electrical pulses to the heart to regulate its rhythm.

Several patients have lost consciousness or developed possible heart failure, the company said. The statement reported the death of one person whose pacemaker may have failed, but Guidant said that the device was not returned for testing and that its role could not be confirmed.

Food and Drug Administration spokeswoman Julie Zawisza said the agency was evaluating Guidant's warning. Guidant said the FDA may classify the warning as a recall. The company issued two safety warnings last month for 11 models of defibrillators that were later classified by the FDA as recalls.

Defibrillators are also implanted devices; they shock the heart back into rhythm. Almost 88,000 of the Guidant devices that were recalled remain implanted worldwide.

The company said it would replace the pacemakers at no charge through the end of the year, even though the warranty on many has expired. Guidant will also reimburse patients up to $2,500 for medical expenses.]]> FDA Announces Guidants Class I Pacemaker Recall http://www.yourlawyer.com/articles/read/10365 Wed, 22 Jun 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10365
Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.

    * PULSAR® MAX Models 1170, 1171, 1270
    * PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
    * DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
    * MERIDIAN® Models 0476, 0976, 1176, 1276
    * PULSAR MAX II Models 1180, 1181, 1280
    * DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
    * CONTAK TR® Model 1241
    * VIRTUS PLUS® II* Models 1380, 1480
    * INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

* VIRTUS PLUS II and INTELIS II models available only outside the U.S.

Guidant announced the initiation of a voluntary recall on July 18, 2005. The recall action consisted of a letter to physicians that describes the problem and provides recommendations about how to minimize the risk of pacemaker failure.

The FDA has classified Guidant's action as a Class I recall. Recall classifications can fall into one of three categories, with Class I being the most serious. These numerical classifications are based on the probability that the device failure could lead to adverse health effects. In a Class I recall, there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.

"Pacemakers are complex medical devices that can extend and improve the lives of many people who have heart rate abnormalities. However, they are not perfect and can malfunction," said Daniel Schultz, M.D., Director, FDA's Center for Devices and Radiological Health. "We are notifying patients and physicians about this important safety matter so they can take prompt action to reduce the risk of serious health consequences."

Some patients are very dependent on pacemakers to maintain an adequate heart rate. For these patients, failure of the device to provide pacing output can cause sudden faintness or loss of consciousness, and can result in death. The leakage defect can also cause a sustained rapid heart rate, which can cause heart failure and result in death.

While the failures can occur without warning, sometimes a leak-related malfunction can be detected by a physician before the malfunction causes serious problems. Guidant has provided information to physicians about ways to identify a leak-related malfunction. However, Guidant is not aware of any test that will show if a normally functioning pacemaker is likely to fail in the future.

As of July 11, 2005, Guidant had received reports that 69 pacemakers may have failed because of the leakage. Twenty of the devices were confirmed to have stopped providing pacing output, resulting in loss of consciousness in five patients. Guidant also received reports of two patients who had sustained pacing at a rapid rate. A patient whose device exhibited sustained pacing at a rapid rate was admitted to the hospital and later died. The device problem could not be confirmed as leakage since the device was not returned.

Approximately 18,000 of the affected devices remain in service in the United States and an additional 10,000 are in service in other countries. Guidant estimates that the failure rate from the leakage defect will be between 0.17% and 0.51% (i.e., between 1.7 per one thousand and 5.1 per one thousand) over the remaining lifetime of the devices. It is possible that the actual failure rate will be greater than this, in part, because some past failures may not have been reported to Guidant.

The FDA is not making a recommendation about whether a patient who has one of the Guidant pacemakers affected by this recall should have it replaced. This is a decision that should be made by the patient in consultation with his or her physician, based on the patient's history and medical condition. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.

The FDA concurs with Guidant's proposed recommendation to patients, which are consistent with the physician recommendations previously set forth in Guidant's July 18 letter:

    * If you believe you are pacemaker dependent, contact your physician soon to discuss your treatment options.
    * Continue your normal doctor appointments.
    * If you experience symptoms of shortness of breath, dizziness, lightheadedness, loss of consciousness, or a prolonged fast heart rate, you should consult with your physician or go to the emergency room immediately.
    * If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.
    * If you know your device's model and serial number and want to find out if it is affected by the leakage problem, you can check www.guidant.com/webapp/emarketing/lookup.jsp or contact Guidant Technical Services at 1-866-GUIDANT (1-866-484-3268).

If you are a physician or a patient who has experienced a problem with any of these pacemakers, please send a report to FDA's MedWatch program and to Guidant. See http://www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).

Guidant has posted information for physicians on its web site at www.guidant.com. Information for patients will be posted soon. If you have further questions, you may contact Guidant at 1-866-GUIDANT (1-866-484-3268).
]]> Guidant Pacemakers Heart Failure Death Injury Attormey http://www.yourlawyer.com/topics/overview/Guidant_Pacemakers Wed, 22 Jun 2005 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/Guidant_Pacemakers Guidant Pacemakers
2005 Recall
Guidant Corp. informed doctors about a new round of safety problems with its implantable heart devices. Guidant, recently recalled many of its heart devices because of safety concerns, said as of July 11, 2005; it had identified 69 of its older pacemakers that may have failed. Approximately 78,000 of the devices were distributed, and close to 28,000 remain implanted in patients. Guidant said the devices have not been sold or implanted for the past four years.

The problem involves a hermetic sealing component that may degrade over time, resulting in higher-than-normal moisture within the pacemaker that could cause "serious health complications. The U.S. Food and Drug Administration may classify this action a recall, Guidant said. Although no failures have been reported prior to 44 months of service, the likelihood increases with time. Guidant's modeling predicts the rate of failure in the remaining implanted devices to be between 0.17% and 0.51% over the rest of the device's life.

The pacemaker brand names involved are Pulsar, Pulsar Max, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, and Contak TR. Guidant recommended that physicians consider replacing the devices for pacemaker-dependent patients, and it advised patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate. Guidant has confirmed 20 reports of loss of pacing output, including five patients experiencing syncope (temporary loss of consciousness and posture).

Loss of pacing output has also been associated with reports of presyncope (lightheadedness), requiring hospitalization. Additionally, Guidant has two reports of sustained maximum sensor rate pacing in which heart failure may have developed. In one report, a patient whose device exhibited sustained MSR pacing was admitted to the hospital with multiple health issues and later died.

2006 Recall
On June 26, 2005, Guidant in conjunction with the FDA notified patients and medical professional that the INSIGNIA and NEXUS implantable pacemakers and the Guidant CONTAK RENEWAL TR/TR2 Cardiac Resynchronization Therapy Pacemakers have been linked to five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Individuals with these pacemakers may suffer irregular or permanent loss of output, telemetry, and or premature battery depletion.

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