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Guidant Implantable Pacemakers
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Guidant Implantable Pacemakers

Guidant Implantable Pacemakers Side Effects Lawsuits | Side Effects: Bradycardia, Heart Blockage, Injury  | Irregular Telemetry, Defective Medical Equipment

Guidant Implantable Pacemakers Side Effects May Be Linked To Bradycardia Lawsuits

Guidant Implantable Pacemakers | Lawsuits, Lawyers | Side Effects: Bradycardia, Heart Blockage, Injury | Irregular Telemetry, Defective Medical Equipment

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.

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...

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....

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...

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

Apr 26, 2006 | Washington Post
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...

Risk cited in replacing heart device

Apr 25, 2006 | AP
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...

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