Internal Defibrillator



             


Saturday, June 7, 2008

Defective Defibrillators and Pacemakers

Cardiac defibrillators are small devices implanted into the body used for regulating the heartbeats of those with heart problems. A small computer is used to detect an irregular heartbeat and shock the heart into the proper rhythm. Boston Scientific/Guidant is one of the nation’s largest manufacturers of defibrillators and pacemakers.

Just recently, Boston Scientific/Guidant and the FDA recalled a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families. This new recall includes about 73,000 implantable cardiac resynchronization therapy defibrillators and cardiac defibrillators due to faulty capacitors. While this recall is similar to the recall of 2006, this time the failure modes and patient outcomes differ. The capacitors have been causing accelerated battery depletion and reducing the time between the elective replacement indicators and end of life to less than three months.

The original recall from Guidant came in June of 2005 when defibrillators implanted in over 50,000 patients worldwide started malfunctioning. In the US alone, there were 38,000 defibrillators implanted during that time and at least 45 of them had failed, resulting in at least 2 deaths. The defibrillator models recalled in 2005 were

• Prizm 2 DR
• Contak Renewal and Contak Renewal 2
• Ventak Prizm AVT
• Vitality AVT
• Renewal 3 AVT and Renewal 4 AVT ICDs

In addition to the defibrillators, Guidant admitted that up to 18,000 pacemakers had a potential defective moisture seal that lead to dysfunction. These pacemakers were next on the recall list. The pacemaker models include

• Pulsar Max
• Pulsar
• Discovery II
• Discovery
• Meridian
• Virtus Plus II
• Intelis II
• Contak TR
• Pulsar Max II

If you or a loved one has been injured by a defective pacemaker or defibrillator you need to seek legal help immediately. You may be entitled to financial compensation for your suffering.

To learn more about the Guidant recall or how to hire a defibrillator lawyer, please visit our website at http://www.resource4guidantrecall.com This article may be freely reprinted as long as this resource box is included and all links stay intact as hyperlinks.

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