Boston Scientific Issues Battery Depletion Warning for ICDs
April 10, 2007 —Boston Scientific Corp. has begun notifying physicians some of its implantable heart defibrillators contain batteries that could deplete early, shortening the life span of the devices, Reuters reported.
In an April 5 letter to doctors posted on Web site of its Guidant unit, the company stated that there have been no patient deaths or serious injuries associated with the battery voltage problem.
Accelerated battery depletion was found to have occurred in 19 of about 73,000 devices in the Vitality family of implantable cardioverter defibrillators (ICDs) that restore heart rhythms and Contak Renewal line of cardiac resynchronization therapy devices, the company's most sophisticated devices to treat heart failure.
Boston Scientific (Charts) bought Guidant last year for $27 billion to acquire its portfolio of heart rhythm management devices. But high-profile recalls of some of the devices have depressed sales. More than 100,000 Guidant heart rhythm devices were recalled between 2005 and 2006.
Boston Scientific estimated that less than two percent of the devices identified are at risk for early battery depletion. The average ICD lasts five to seven years.
The letter provides guidelines for identifying which patients have devices with faulty batteries and recommends monitoring them every month instead of the usual every three months.
JP Morgan analyst Michael Weinstein said FDA would likely classify Boston Scientific's notification as a Class II recall.
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