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FOLLOW-UP: GUIDANT CONTINUED TO SELL HEART DEFIBRILLATOR FOR IMPLANTATION IN PATIENTS EVEN AFTER BECOMING AWARE OF A DEFECT WHICH COULD CAUSE THE DEVICE TO SHORT-CIRCUIT AND FAIL

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Despite the fact that company officials were aware of an electrical defect which had caused some of its internal heart defibrillators to short-circuit and fail to operate, Guidant Corp. continued to sell the device even after making a manufacturing change to correct the problem. Eventually, 26 out of 37,000 devices malfunctioned. At least one of those failures occurred in a 21-year-old college student who died while on a bicycle trip during Spring Break.

Since the purpose of an electrical heart defibrillator is to shock an irregularly beating heart back into proper rhythm, any malfunction can be extremely serious. In fact, if normal heart rhythm is not restored, death will result within minutes. Guidant continues to maintain that the incidence of malfunction was so small that a recall was unwarranted. Patients relying on the device and their doctors are understandably not in agreement with Guidantís position.

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