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Boston Scientific tells doctors of battery risk in defibrillators

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From Reuters

Boston Scientific Corp. has notified doctors that some of its implantable heart defibrillators contain batteries that could deplete early, shortening the life span of the devices.

There have been no patient deaths or serious injuries associated with the battery voltage problem, the company said in a letter to doctors dated Thursday and posted on the website of its Guidant unit.

Accelerated battery depletion was found to have occurred in 19 of about 73,000 devices in the Vitality family of implantable cardioverter defibrillators, which restore heart rhythms, and the Contak Renewal line of cardiac resynchronization therapy devices, the company’s most sophisticated devices to treat heart failure.

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Boston Scientific 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.

Wall Street analysts called the latest safety advisory yet another setback for a company that has fought to improve quality controls and regain market share after the series of recalls.

In its letter to doctors, Boston Scientific estimated that fewer than 2% of the devices identified were at risk for early battery depletion. The average implantable defibrillator lasts five to seven years.

The firm provided guidelines for identifying which patients have devices with faulty batteries and recommended monitoring them every month instead of the usual three months.

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