INDIANAPOLIS, May 24 (UPI) -- Indianapolis-based Guidant Corp. waited three years before revealing its defibrillator had a design flaw, the New York Times reported Tuesday.
The small devices called Ventak Prizm 2 Model 1861s are implanted in the chests of about 24,000 people to electrically shock an erratically beating heart. The problem came to light when a 21-year-old Minnesota college student died of cardiac arrest while on spring break when his defibrillator short-circuited.
Guidant later told doctors it was aware of 25 other cases in which the defibrillator had been affected by the same flaw, and said it had changed its manufacturing processes three years ago to fix the problem. Doctors said had they known earlier, they would have replaced the unit because the student was at high risk of sudden death.
Guidant's Dr. Joseph Smith told the Times the company had not seen a compelling reason to issue an alert to physicians about the defibrillators because the failure rate was very low and replacing the devices might pose greater patient risks.
