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Guidant Heart Defibrillators
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Internal Cardiac Defibrillator
On June 17, 2005, Guidant announced the recall of seven defective internal cardiac defibrillator models for wiring problems that have caused serious patient injury and death. These internal cardiac defibrillator defects have already resulted in two patient deaths and at least 45 potentially fatal device failures. The Guidant internal cardiac defibrillator recall includes 50,000 devices that are currently in use, at least 20,000 of which are implanted into American patients.
An internal cardiac defibrillator is a device that is implanted into the body to monitor, detect, and correct certain types of heart arrhythmias. Ventricular tachycardia and ventricular fibrillation, both specific types of heart arrhythmias, are conditions where the heart beats rapidly and/or irregularly. These potentially fatal conditions tend to develop in people with coronary artery or heart muscle diseases. The risk of fainting or suffering a heart attack is increased in patients with heart arrhythmias.
In order to correct these potentially life threatening heart conditions, a internal cardiac defibrillator detects abnormalities and corrects them by delivering precise, calibrated, and timed electrical shocks which restore a normal heart beat. Thousands of Americans depend on their internal cardiac defibrillator to correct these arrhythmias and prevent fatal complications. When an internal cardiac defibrillator fails, they pose a serious threat to patients’ lives.
The Guidant recall has left thousands of Americans worried and wondering what to do about their internal cardiac defibrillator. Neither the FDA nor Guidant have recommended removing or replacing Guidant internal cardiac defibrillators or allowing them to remain in place. The manufacturer has announced that they will pay to replace 28,900 internal cardiac defibrillators, which cannot be fixed without removing the mini-cassette sized medical device. The internal cardiac defibrillator models that must be removed to be fixed include: Ventak Prism DR, Contak Renewal and Renewal 2, and Contact Renewal 3 AVT and 4 AVT. Internal cardiac defibrillator models Ventak Prism AVT and Vitality AVT are able to be fixed with non-invasive external reprogramming. View the full list of the defibrillators affected.
If you or a loved one has a Guidant internal cardiac defibrillator and you are worried about these serious risks, it is important to speak with your physician or cardiac specialist who can determine what actions are in your best interest. For some patients, surgical removal of their internal cardiac defibrillator may be best, while allowing the device to remain in place may be better for other patients.
Guidant was once affiliated with pharmaceutical giant Eli Lilly. Due to economic turmoil and other problems, Guidant’s shareholders voted in April 2005 to allow Johnson and Johnson to acquire the company. The Guidant internal cardiac defibrillator recall is expected to affect this acquisition, though Johnson and Johnson has made no public announcement regarding this massive recall.
If you or a loved one has been injured by a Guidant internal cardiac defibrillator or you have questions about these defective devices, please contact us to speak with a reputable and highly qualified attorney.
Product Liability Breaking News
"Guidant Heart Defibrillator Claims"
Boston Scientific Corp. has amended a settlement agreement involving faulty Guidant defibrillator claims to include an additional $45 million, bringing the total settlement amount to $2...
"FDA Urges Patients to Schedule Exam"
A statement released yesterday by the U.S. Food and Drug Administration urged patients with potentially defective models of Boston Scientific/Guidant pacemakers and defibrillators to schedule an exam with their physicians as soon as possible.
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"Defibrillators May fail 10 times more than projected"
A U.S. Food and Drug Administration analysis found that Guidant defibrillators may fail as much as 10 times more than the company projected last year.
Guidant defibrillators have been implanted into thousands of cardiac patients and are used t...
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