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Guidant delayed disclosing device defect -NY Times
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Roman Bystrianyk
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Joined: 02 May 2005
Posts: 454

PostPosted: Tue May 24, 2005 7:51 am    Post subject: Guidant delayed disclosing device defect -NY Times Reply with quote

"Guidant delayed disclosing device defect -NY Times", Reuters, May 24,
2005,
Link:
http://www.reuters.com/newsArticle.jhtml;jsessionid=EP02I0RJZHAUQCRBAE0CFEY?type=healthNews&storyID=8583492

Guidant Corp. failed to inform doctors or patients for three years that
one of its defibrillators implanted in an estimated 24,000 patients had
a defect that caused some of the devices to short-circuit and
malfunction, the New York Times reported on Tuesday.

A defibrillator uses an electrical charge to shock a dangerously racing
heart back into its normal rhythm.

The defect came to light after the sudden death in March of a
21-year-old college student with heart disease who had the Guidant
defibrillator implanted in his chest, the report said.

Guidant, which is being acquired by Johnson & Johnson, acknowledged
that Joshua Oukrop's defibrillator had short-circuited, the Times said.

Oukrop was on a bicycling trip in Utah when he got off his bike,
complaining of fatigue. He fell to the ground and died of cardiac
arrest.

His is the only known death involving the device -- a unit known as the
Ventak Prizm 2 Model 1861, the newspaper said.

Following Oukrop's death, Guidant told his doctors that it was aware of
25 other cases in which the defibrillator had been affected by the same
flaw, the report said.

Guidant said it had changed its manufacturing processes three years ago
to fix the problem. The physicians said that had they known of the
problem earlier, they would have replaced Oukrop's unit because he was
at high risk of sudden death, the Times reported.

Guidant officials were not immediately available to comment on the
newspaper account.

But the newspaper cited a Guidant executive, Dr. Joseph Smith, as
saying the medical device maker had not seen a compelling reason to
issue an alert to physicians because the unit's failure rate was very
low and replacing the devices might pose greater patient risks.

The newspaper account said that only after learning that the Times was
about to publish an article about problems with the device did Guidant
issue an advisory to doctors. In that advisory, which physicians could
receive on Tuesday, Guidant recommends that the unit not be replaced
because of the electrical problem.
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