FDAnews Device Daily Bulletin

FDA SAYS EXAMS FOR PATIENTS IMPLANTED WITH GUIDANT CARDIAC DEVICES A GOOD IDEA

July 13, 2006
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The FDA July 11 said it supports Boston Scientific's recommendation for physicians to conduct follow-up examinations on patients implanted with potentially faulty Guidant defibrillators and pacemakers.

The firm recently recalled certain models of Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators.

Boston Scientific discussed device-related safety issues in a letter to physicians dated June 23, saying the devices should be removed from hospital inventories because they have the potential to malfunction due to failure of the capacitor.

The FDA announcement can be viewed at www.fda.gov/bbs/topics/NEWS/2006/NEW01407.html (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01407.html).