Faulty Batteries in Defibrillators
Reported January 21, 2005
(Ivanhoe Newswire) –The medical device maker Medtronic, Inc., has begun warning physicians about faulty batteries in a line of its implantable defibrillators.
Batteries in the Marquis line of implantable cardioverter-defibrillators (ICDs) made before December 2003 lost power after just a few days in nine reported cases out of 87,000 devices used worldwide. These batteries should last several years.
Although none of the patients was harmed by the problem, cardiac electrophysiologist Ted Chow, M.D., of The Ohio Heart and Vascular Center in Cincinnati, tells Ivanhoe, “There are some patients for whom if the device were to stop working abruptly, they would suffer immediate and serious consequences. Those patients would include those who have very, very slow heart rates that actually require the device in order to keep their heart rates up through pacing. Most patients, fortunately, are not in that category. Most patients have a stable underlying heart rhythm, and the device is merely meant to be a seat belt or insurance policy against dangerous arrhythmias that may or may not ever occur.”
Dr. Chow says patients should contact their physician if they think they have a potentially affected device. If so, he says there are two possible measures to take. The first and more conservative option is replacing the generator, which is the box under the skin. He says it is a quick and easy procedure.
Patients can also opt to test the batteries themselves by placing a special magnet from their physician over the device. However, since the battery can become discharged in such a short period of time, patients would have to do this daily.
Philip Adamson, M.D., a cardiologist at the University of Oklahoma Health Sciences Center, tells Ivanhoe patients should mainly focus on being followed up regularly enough to know if the battery is about to run out. He says, “Medtronic is typically very conservative about problems with their devices.” He does not see the problem as much of a threat to his patients.
Steve Mahle, president of Medtronic Cardiac Rhythm Management, says, “Even though the potential for rapid battery depletion is extremely low, we see it as our obligation to alert all implanting physicians to the potential issue and provide ways to help them and their affected patients successfully manage the situation.”
SOURCE: Medtronic, Inc., Feb. 11, 2005, Ivanhoe interviews with Ted Chow, M.D., and Philip Anderson, M.D.
