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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.
According to a recent Boston Scientific/Guidant announcement, several models of its pacemakers and implantable defibrillators may be susceptible to malfunction as the result of defective capacitators. The company subsequently recalled nearly 30,000 of devices.
Problems with the faulty pacemakers and defibrillators may include premature battery depletion and intermittent or permanent loss of therapy, among other things. Recalled models include certain Insignia and Nexus pacemakers, Contak Renewal pacemakers, and Ventak Prizm and Vitality defibrillators.
These devices were implanted into patients between December 2005 and June 2006. Thus far, there have been five confirmed reports of malfunctioning devices in patients. Two of these patients lost consciousness and four required replacement surgery.
“We encourage patients who have been contacted by their physicians because they may have one of the affected devices to follow their recommendation and make an appointment to have the device checked as soon as possible,” said Daniel Schultz, M.D., and Director of the FDA''s Center for Devices and Radiological Health.
The company is currently investigating the rate of failure in the devices and will report its findings to the FDA as soon as they are available. The FDA is encouraging those who experience problems with the devices, to submit a report to its MedWatch program.
To learn more about your legal rights if you or someone you love has suffered injury because of a defective pacemaker or defibrillator, please click here .