On May 23, 2005, Guidant Corporation, a medical device maker, issued a safety advisory to physicians concerning its heart defibrillator, the Ventak Prizm Model 1861.
The advisory was issued reportedly after Guidant learned an article was being prepared on the device. The New York Times reported that Guidant did not tell doctors or patients for three years that the device contains a flaw that has caused a small number of defibrillators to short-circuit and stop working.
Guidant's one-page "Dear Doctor" advisory, which arrived in doctors' offices Tuesday, reveals that one patient has died and 25 others required replacement implants as a result of the flaw in the Prizm 2 defibrillator. About 37,000 of the devices that might contain the flaw were implanted in heart patients worldwide. Guidant's letter does not call for early replacement of the Prizm 2 models with new units. Battery-powered defibrillators are used to shock an erratically beating heart back into normal rhythm. The devices typically are replaced about every five years.
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