Everything Science Forum

Guidant Didn't Disclose a Flaw in Defibrillator for 3 Years

By BARRY MEIER (NY Times)
Published: May 24, 2005

A medical device maker, the Guidant Corporation, did not tell doctors or patients for three years that a unit implanted in an estimated 24,000 people that is designed to shock a faltering heart contains a flaw that has caused a small number of those units to short-circuit and malfunction.

The matter has come to light after the death of a 21-year-old college student from Minnesota, Joshua Oukrop, with a genetic heart disease. Guidant acknowledges that his device, known as a defibrillator, short-circuited. The young man was in Moab, Utah, on a spring break bicycling trip in March with his girlfriend when he complained of fatigue. He then fell to the ground and died of cardiac arrest.

Guidant subsequently told his doctors that it was aware of 25 other cases in which the defibrillator, a Ventak Prizm 2 Model 1861, had been affected by the same flaw. Guidant said it had changed its manufacturing processes three years ago to fix the problem. The physicians say that had they known earlier, they would have replaced the unit in their patient because he was at high risk of sudden death. His death is the only one known.

more . . .  (http://www.nytimes.com/2005/05/24/business/24heart.html?th&emc=th)

Hubby has Guidant installed in his person ...gulp !  Not that model...but, thanks for the info...I think...(seems to have been working ok for past...10 months ...ALREADY 10 months ?...!!!). :o

For what it's worth, in 13 years in Medical Electronics, I'd never heard of (major) problems with any Guidant products.  And unlike most industries, Medical Device Technology is regulated and scrutinized heavily (by the AMA, FDA, and an agency known as "ECRI," which is the industry equivalent of UL).

Which makes me wonder how this one slipped by.