Heart Device Recall Lawsuit News

Medtronic of Canada Ltd. (Medtronic) in consultation with Health Canada

Thu, 10 Jan 2008 13:41:51 -0500

Medtronic of Canada Ltd. (Medtronic) in consultation with Health Canada is advising patients that it has voluntarily suspended the distribution of the Sprint Fidelis defibrillation leads (models 6930, 6931, 6948, 6949). Sprint Fidelis leads are thin wires that connect a defibrillator implanted near the shoulder to your heart.

Medtronic has informed your doctor that there is a small chance of fractures in particular locations on the lead and has advised doctors to stop implanting the leads and return the unused products to the firm.

Lead fractures could cause the defibrillator to deliver unnecessary shocks or, in very rare instances, to fail to deliver a shock. If you have one of the affected leads, your Patient ID card should contain one of the following four sets of numbers: 6930, 6931, 6948, and 6949, shown at the beginning of a longer set of numbers on your ID card. You will be contacted directly by your doctor for follow-up. Your doctor may choose to change the way your device is programmed to help reduce any potential problems.

The suspension of distribution does not require your Sprint Fidelis Lead to be removed and replaced, because the risk of removal in most patients exceeds the small risk of lead fractures. In consultation with your doctor, you can decide what is best for you.

Sprint Fidelis Leads have been available in Canada since July 2004. Medtronic's decision to suspend distribution of the Sprint Fidelis Leads was made following a review of recommendations by an Independent Physician Quality Panel. As of October 4, 2007, approximately 268,000 Sprint Fidelis Leads have been implanted worldwide.

Medtronic is aware of five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. None of these deaths are in Canada.

Sprint Fidelis Recall

Mon, 22 Oct 2007 08:40:24 -0500

See Medtronic's Web Site for important recall information on the Sprin Fidelis 6930, 6931, 6948, 6949 models.

To Recall or Not Recall Guidant Medical Devices

Thu, 12 Oct 2006 09:49:42 -0500

The Food and Drug Administration is considering not using the word recall to warn patients and doctors about defective pacemakers and defibrillators at the request of the Heart Rhythm Society, a physicians' group struggling to deal with a loss of public confidence in the safety of implantable heart devices.

The word "recall" creates too much anxiety among patients and physicians. Patients who learn they have a faulty device often assume they need to have it removed immediately, even though the surgical procedure to replace the device typically involves more risk than leaving it in.

The Heart Rhythm Society released guidelines asking the FDA to use safety advisory or safety alert when referring to Guidant medical device problems.

The FDA has issued safety alerts and recalls affecting more than 337,000 defibrillators since 1990. On average, less than 5 in 1,000 pacemakers and 21 in 1,000 defibrillators have had malfunctions resulting in replacement. (PE.com)

Protecting the Public: Guidant Medical Devices and Unsafe Drug Litigation Seminar

Thu, 12 Oct 2006 09:48:36 -0500

ATLA SEMINAR: Protecting the Public: Guidant Medical Devices and Unsafe Drug Litigation Seminar

Does a life saving medical device actually save lives or threaten lives? What unsafe drugs currently on the market will become the next Vioxx? As the number of drug recalls increases, having an understanding of the potential risk factors becomes more critical for attorneys who represent people injured by the products that claim to help.

The Association of Trial Lawyers of America (ATLA) hosts a seminar on November 17-18 at the Wynn Las Vegas. Program highlights include litigation updates on Guidant, Medtronic, Vioxx, Ortho Evra, Zyprexa, Fosamax, SSRIs, Hormone Therapy, and Bausch & Lomb.

Guidant Tries to Keep Prices Secret

Fri, 29 Sep 2006 13:42:19 -0500

In May 2006, a lawsuit was filed in Pennsylvania by Public Citizen on behalf of Emergency Care Research Institute (ECRI), the nation's leading independent medical product testing organization, the right to publish information about Guidant's medical devices. ECRI's guide is intended to assist hospitals, health care consultants, group purchasing organizations, health plans, and government agencies with making decisions about the cost-effectiveness of various competing medical devices.

Guidant recently developed a business model requiring all of its customers to keep its product prices confidential. ECRI and others members was unaware of this new business model or consent to be bound by confidentiality clauses in Guidant's contracts. Guidant insists that the public is bound to obey its contracts with customers and therefore ECRI should not be allowed to publish Guidant's product prices.

Guidant's attempt to suppress publication of product prices also contravenes the strong public policy favoring price transparency. Under Guidant's business model, even pacemaker patients and implanting physicians are forbidden from knowing the price of the device. The exclusion of the data from ECRI's publication puts consumers at a disadvantage and is a detriment to the healthcare system. (Public Citizen)

FDA: Guidant pacemakers and implantable defibrillators

Fri, 22 Sep 2006 13:43:45 -0500

In July 2006, FDA met with 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. The capacitor controls how the device holds its power supply. The FDA fully supports Guidant's recommendation that physicians perform follow-up exams of patients with devices that may be susceptible to this malfunction.
Guidant's problems may include intermittent or permanent loss of therapy, premature battery depletion, or other malfunctions. The FDA is closely monitoring the situation and met with Guidant to discuss their plans to investigation the problem, inform physicians, and resolve the problem as quickly as possible. (FDA)

Trauma from Recalls of Guidant Implanted Devices

Thu, 14 Sep 2006 19:22:29 -0500

Imagine having an implanted pacemaker or defibrillator. Imagine thinking that these lifesaving devices are going to save your life. If only it was that simple. Hundreds of thousands of Guidant implanted pacemakers and defibrillators are being recalled which means that hundreds of thousands of patients have to go to the hospital to have the Guidant heart devices removed and have new heart devices replanted. This sets up patients for anxiety, trauma, infection, expense, death, and cause for alarm as to question the safety of the newly implanted devices.

Within the past 18 months the Food and Drug Administration recall notices have targeted more than 300,000 implantable heart devices, a majority from Guidant Corporation. Problems with devices have ranged from minor flaws to premature battery depletion. In some instances, a malfunction allowed moisture to seep into the device. A recall last year of a Guidant defibrillator has prompted by at least two deaths. (Red Orbit)

Wikipedia Infromation on heart defibrillators

Wed, 13 Sep 2006 19:25:05 -0500

What is a heart defibrillator?

An implantable cardioverter-defibrillator (ICD) is a device that is implanted under the skin of patients that are at risk of sudden cardiac death. The defibrillator was designed primarily to deal with ventricular fibrillation or coordination of the heart muscle to pump blood. The process of implanting an ICD is similar to that of a pacemaker. ICDs constantly monitor the rate and rhythm of the heart and are programmed to deliver an electrical shock when the ventricles of the heart go faster than the set rate.

Defibrillator Safety Alerts Occur Frequently

Sun, 10 Sep 2006 11:02:50 -0500

The FDA frequently issues safety advisories for automated external defibrillators (AEDs) or portable electronic device used to restore regular heart beat in patients with cardiac arrest. Successful resuscitation of persons with cardiac arrest depends on prompt emergency care, with early defibrillation a key component to improved survival.

Automated external defibrillators are easy to use, but are technically complex devices that occasionally malfunction. Automated external defibrillators were recalled in 9 of the 10 study years, and AED accessories were recalled in 7 of the 10 years studied. No year was advisory free. As the prevalence of AEDs continues to increase, the number of devices affected by advisories can also be expected to increase. Efforts should be directed at developing a reliable system to locate and repair potentially defective devices in a timely fashion. (Medical News Today)

Guidant letter about risks never sent

Sun, 3 Sep 2006 11:02:00 -0500

In June 2006, new unsealed court documents show that Guidant Corp. drafted a letter warning doctors of a dangerous electrical malfunction in some of its defibrillators designed to restore a normal heartbeat, however, the letter was never sent. Instead, a toned down letter was sent about a rare malfunction. Guidant officials worried about creating undue alarm.

Guidant executives told regulators that they believed there was a low risk of further problems from the flaw, despite two patient deaths at that point. Guidant ultimately ended up recalling 88,000 defibrillators including the two models at issue in the warning that was never sent to doctors. Guidant also has recalled or issued safety warnings for more than 200,000 pacemakers. At least seven deaths have been linked to the devices. (CBS)