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

[DeepModem Mom]

Guidant Didn't Disclose a Flaw in Defibrillator for 3 Years
By BARRY MEIER
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....

***

In interviews in recent days, a top Guidant executive, Dr. Joseph M. Smith, said that 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.

But late yesterday, when told that The New York Times was preparing an article about the device, the company issued an advisory to doctors about it. Guidant is recommending that the unit not be replaced because of the electrical problem.

The episode highlights an important issue: Doctors and patients are not always told when a medical device maker has data indicating that its product has a flaw that, while rare, poses potential dangers. Also, companies are not required to report immediately all safety modifications to the Food and Drug Administration....


http://www.nytimes.com/2005/05/24/business/24heart.html?hp

[riverwalker]

1. there is no risk in replacement

"replacing the devices might pose greater patient risks."
This is BS. Guidant is outright lying. This is a very, very safe procedure, you don't even need general anesthesia and can go home the next day. The only "risk" was to their bottom line.

[jaysunb]

2. I had mine removed in 2002

and I definitely didn't go home the "next day" or for the next 14 either !

I'll be waiting for the lawsuit to commence :evilgrin:

[DeepModem Mom]

3. Thanks for posting your personal experience, j --

and it does sound like a lawsuit should be in the works.