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Guidant Pacemakers

Guidant Pacemakers Side Effects Lawsuits | Side Effects: Heart Failure, Shortness of Breath, Fast Heart Rate, Injury, Death | Device Failure, Faulty Component

Guidant Pacemakers Side Effects Could Be Linked To Heart Failure Lawsuits

Guidant Pacemakers | Lawsuits, Lawyers | Side Effects: Heart Failure, Shortness of Breath, Fast Heart Rate, Injury, Death | Device Failure, Faulty Component

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.

Legal Help For Victims Affected By Guidant Pacemaker

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 or call us at 1-800-YOURLAWYER (1-800-968-7529).



 

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Changing ICD generator elevates risk factor for Sprint Fidelis lead failures

Jun 18, 2012 | Parker Waichman LLP
Patients relying on an implantable cardiac defibrillator (ICD) are more likely to experience malfunctions and failures with the Sprint Fidelis leads connecting it to the heart if they change the device's generator. According to a report at TheHeart.org, new research from Emory University identified changing the generator on an ICD device while keeping the Sprint Fidelis leads would likely lead to a device failure. The Sprint Fidelis lead was recalled in 2007 following scores of reports of its...

Defective Guidant Defibrillators Continue to Haunt Boston Scientific

Sep 11, 2006 | Newsinferno.com
According to recent SEC filings, Boston Scientific Corp. now faces about 477 individual and 72 class-action lawsuits over 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...

FDA Update Statement On Boston Scientific/Guidant Pacemakers And Defibrillators

Jul 17, 2006 | www.medicalnewstoday.co
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....

Boston Scientific Announces Physician Communication Related to Products in Its CRM Group

Jun 26, 2006 | www.fda.gov
Contact:Paul Donovan508-650-8541 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...

Replacing Heart Device Found Risky

Apr 26, 2006 | Los Angeles Times
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...

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