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FDA Update Statement On Boston Scientific/Guidant Pacemakers And Defibrillators

Mon, 17 Jul 2006 00:00:00 -0700

The FDA met last week with Boston Scientific/Guidant to discuss the firm's recent announcement that several models of pacemakers and implantable defibrillators should be removed from hospital inventories because they have the potential to malfunction due to failure of the capacitor, which controls how the device holds its power supply. FDA fully supports the company's recommendation that physicians perform follow-up exams of patients with devices that may be susceptible to this malfunction. Problems may include intermittent or permanent loss of therapy, premature battery depletion or other malfunctions. FDA is closely monitoring the situation and met with Boston Scientific/Guidant to discuss their plans to investigation the problem, inform physicians and resolve the problem as quickly as possible.

"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.

Studies show implanted heart device can malfunction, but removal's risky

Wed, 26 Apr 2006 00:00:00 -0700

Implantable defibrillators, which can deliver a life-saving shock to people with damaged hearts, have had a roller-coaster record of reliability, as the rate of malfunctions fell in the early years, rose in the late 1990s and recently declined again.

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

Wed, 26 Apr 2006 00:00:00 -0700

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

Tue, 25 Apr 2006 00:00:00 -0700

A new study suggests that for some patients with implanted heart defibrillators that have been recalled by the manufacturer, replacing the device might be riskier than leaving it in.

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.

Guidants Troubles Continue to Grow

Thu, 29 Sep 2005 00:00:00 -0700

Criminal investigators at the U.S. Food and Drug Administration have joined the agency’s probe into how Guidant Corporation handled problems with its heart devices, according to Thursday’s New York Times.

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

Mon, 26 Sep 2005 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) has released its review of implantable cardioverter defibrillator (ICD) and pacemaker (PM) malfunctions for the period from 1990-2002.

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

Fri, 23 Sep 2005 00:00:00 -0700

Guidant Corp. issued recalls Thursday for some of its best-selling pacemakers. Citing problems with the Insignia and Nexus families of implantable pacemakers, Guidant informed physicians that the devices may fail because of problems discovered by the U.S Food and Drug Administration (FDA).

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.

Guidant Initiates Voluntary Physician Advisory on Certain Pacemakers

Thu, 22 Sep 2005 00:00:00 -0700

Guidant Corporation said today that it is informing physicians about two separate failure modes, each occurring at a low rate, being monitored within the INSIGNIA(R) and NEXUS(R) families of Guidant implantable pacemakers. Physicians should use this information to decide how best to treat their patients.

These failure modes may result in one or more of the following device behaviors:

Intermittent or permanent loss of pacing output without warning

Intermittent or permanent loss of telemetry

Appearance of a reset warning message upon interrogation

The clinical behaviors associated with these failure modes can result in serious health complications. There have been no reported deaths resulting from these failure modes. Loss of pacing output associated with these failure modes has resulted in syncope as well as presyncope requiring hospitalization.

For the first failure mode, as of September 6, 2005, Guidant has confirmed thirty-six (36) failures out of 49,500 implanted devices (0.073%). Seven (7) of these devices exhibited no output during the implant procedures. For devices successfully implanted, the majority of failures occurred early in life, with a mean implant time of seven (7) months. This failure mode demonstrates a failure rate that decreases with implant time. No failures have been reported beyond twenty-two (22) months of service. Guidant has received three (3) reports of syncope, and six (6) reports of bradycardia or heart block associated with this failure mode which required emergency hospitalization. One device was determined to have failed briefly and resumed functioning with no indication to the physician detectable during routine follow-up.

Guidant's modeling based on field experience and statistical analysis, predicts the failure rate for the active device population of 41,000 to be between 0.017% to 0.037% over the remaining device lifetime, or approximately seven (7) to fifteen (15) additional failures. An estimated 24,000 are active in the United States. Root cause has been identified as foreign material within a crystal timing component. The supplier of the crystal timing component used in this subset has eliminated foreign material within the crystal chamber, and no such failures have been observed in any devices shipped after March 12, 2004.

The United States Food and Drug Administration (FDA) has determined this communication action to be a recall. Physicians should consider the projected low and declining failure rate in addition to the unique needs of individual patients in their medical decisions regarding patient management. Guidant recommends normal device monitoring, as per device labeling. As always, Guidant advises patients to seek medical attention immediately if they experience syncope or lightheadedness.

As of September 6, 2005, sixteen (16) failures associated with a second failure mode have been confirmed out of 341,000 INSIGNIA and NEXUS devices distributed worldwide (0.0047%). For all sixteen devices, a "no output" condition was exhibited at the implant procedure or pre-implant testing. Guidant has received one (1) report of a pacemaker-dependent patient experiencing syncope and resuscitated cardiac arrest that occurred in association with loss of pacing output during an elective pulse generator replacement procedure. Root cause analysis is ongoing; a specific root cause for this observation has not yet been determined. An estimated 145,000 of these devices are active in the United States.

The United States Food and Drug Administration (FDA) may determine this communication action to be a recall. Guidant recommends verifying pacemaker operation in the packaging prior to the implant procedure. Devices exhibiting intermittent or permanent loss of output and/or telemetry should not be implanted. Physicians should consider both the very low occurrence rate and that no failures have been observed after successful confirmation of pacing at implant, in addition to the unique needs of individual patients, in their medical decisions regarding patient management.

The following model numbers are affected by this communication(a):

         Guidant Pacemakers           Guidant Intermedics Pacemakers
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Device Family      Model Numbers     Device Family   Model Numbers
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INSIGNIA Entra SSI 0484, 0485        NEXUS Entra SSI 1325, 1326
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INSIGNIA Entra DDD 0985, 0986        NEXUS Entra DDD 1425, 1426
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INSIGNIA Entra SR 1195, 1198        NEXUS Entra SR 1395, 1398
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INSIGNIA Entra DR 1294, 1295, 1296 NEXUS Entra DR 1466, 1494, 1495
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INSIGNIA Ultra SR 1190              NEXUS Ultra SR 1390
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INSIGNIA Ultra DR 1290, 1291        NEXUS Ultra DR 1490, 1491
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INSIGNIA Plus SR   1194              NEXUS Plus SR   1394
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INSIGNIA Plus DR   1297, 1298        NEXUS Plus DR   1467, 1468
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INSIGNIA AVT SSI   482               NEXUS AVT SSI   1328
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INSIGNIA AVT VDD   882               NEXUS AVT VDD   1428
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INSIGNIA AVT DDD   982               NEXUS AVT DDD   1432
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INSIGNIA AVT SR    1192              NEXUS AVT SR    1392
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INSIGNIA AVT DR    1292              NEXUS AVT DR    1492
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(a) Not all models are available in all geographies.

Thu, 22 Sep 2005 00:00:00 -0700

Guidant INSIGNIA and NEXUS Implantable Pacemakers

2005 Recall
Guidant Corporation on September 22, 2005 informed physicians about two isolated failure modes, for the INSIGNIA and NEXUS families of Guidant implantable pacemakers. The failure modes can result in one or more of the following device behaviors: a) Irregular or permanent loss of telemetry; b) Appearance of a reset warning message upon interrogation; and c) Sporadic or permanent loss of pacing output without warning. The FDA has determined this communication action to be a recall.

The clinical behaviors connected with these failure modes can cause serious health complications. Loss of pacing output related to these failure modes has resulted in syncope as well as presyncope requiring hospitalization. For the first failure mode, as of September 6, 2005, Guidant has confirmed 36 failures out of 49,500 implanted devices (0.073%). Seven of these devices exhibited no output during the implant procedures. For devices successfully implanted, the majority of failures occurred early in life, with a mean implant time of seven months.

Guidant has received three reports of syncope, and six reports of bradycardia or heart block associated with this failure mode which required emergency hospitalization. One device was determined to have failed briefly and resumed functioning with no indication to the physician detectable during routine follow-up.

Guidant's modeling based on field experience and statistical analysis, predicts the failure rate for the active device population of 41,000 to be between 0.017% to 0.037% over the remaining device lifetime, or approximately seven to fifteen additional failures. An estimated 24,000 are active in the United States. As of September 6, 2005, sixteen (16) failures associated with a second failure mode have been confirmed out of 341,000 INSIGNIA and NEXUS devices distributed worldwide (0.0047%). For all sixteen devices, a "no output" condition was exhibited at the implant procedure or pre-implant testing. Guidant has received one (1) report of a pacemaker-dependent patient experiencing syncope and resuscitated cardiac arrest that occurred in association with loss of pacing output during an elective pulse generator replacement procedure.

The following model numbers are affected:

Guidant Pacemakers
INSIGNIA Entra SSI 0484, 0485; DDD 0985, 0986; SR 1195, 1198; DR 1294, 1295, 1296; Ultra SR 1190; DR 1290, 1291; Plus SR 1194 INSIGNIA Plus DR 1297, 1298 NEXUS Plus DR 1467, 1468; AVT SSI 482 NEXUS AVT SSI 1328; AVT VDD 882; AVT DDD 982; AVT SR 1192; AVT DR 1292.

Guidant Intermedics Pacemakers
NEXUS Entra SSI 1325, 1326; DDD 1425, 1426; SR 1395, 1398; DR 1466, 1494, 1495; Ultra SR 1390; DR 1490, 1491; Plus SR 1394; DR 1467, 1468, AVT SSI 1328; VDD 1428, DDD 1432, SR 1392, DR 1492.

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.