Ed Kensik05.17.06
Natick, MA-based Boston Scientific announced that it sent product advisories to physicians warning them that some products from recently acquired heart device company Guidant could have batteries that expire prematurely, according to the Associated Press.
After conducting a product performance review, Boston Scientific said that a defect causing batteries in implantable heart defibrillators to lose their charge was limited to one lot of the devices because of a single batch of electronic components from a certain manufacturer.
Less than one percent, or 996 devices implanted worldwide, have these components and have a higher risk for battery failure.
Boston Scientific acquired Guidant of Indianapolis, IN on April 21 to form the company's Cardiac Rhythm Management Group.
As of May 8, the company confirmed battery failure in 30 devices that had been returned, and received 46 reports of implanted devices that show signs of early battery depletion. Boston Scientific said no deaths or injuries have been reported from devices covered in the advisory.
The company also told doctors to be wary of implanting Renewal 3, Renewal 4, and Vitality HE defibrillators under the muscle rather than under the skin since repetitive stress could damage the devices case.