What is an example of a defective medical device?
A recent example of a defective medical device is the Guidant Defibrillator. Indianapolis-based Guidant Corp. alerted doctors that nine pacemaker models made from 1997 to 2000 might need to be replaced. An estimated 28,000 of the pacemakers remain implanted in patients worldwide, with about 18,000 of those in U.S. patients. The company said that a sealing component in the pacemakers has degraded in some cases, resulting in higher-than-normal moisture in the devices that could cause a malfunction. Several patients have lost consciousness or developed possible heart failure. The company reported the death of one person whose pacemaker might have failed, but it said the role of the device could not be confirmed as it was not returned for testing.
