Medtronic
Medtronic Defibrillator may experience rapid batter depletion.
Medtronic, Inc., has voluntarily advised physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models.
In a letter to physicians, Medtronic reported that nine batteries (0.01 percent or approximately 1 in 10,000) have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths.
Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Potentially affected models are the Marquis VR/DR and Maximo VR/DR ICDs and the InSync I/II/III Marquis and InSync III Protect CRT-D devices.
Approximately 75 percent of these devices were implanted in the United States. Patients with other models of Medtronic devices or these device models with batteries manufactured after December 2003 are not affected.
As part of the company's program to analyze products returned from physicians, Medtronic identified nine of 87,000 implanted devices (0.01 percent) with a battery design that exhibited this shorting mechanism. Based on highly accelerated company testing, Medtronic estimates that this rate may increase up to between 0.2 percent and 1.5 percent over the second half of device life.
For more information see the Medtronic web site at
http://www.medtronicinfo.com/overview.asp
|
