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Implanted defibrillator maker stands by device despite electrical problem

Wednesday, May 25, 2005

INDIANAPOLIS -- The maker of an internal heart defibrillator is acknowledging it waited three years before telling some 24,000 patients and their doctors about an electrical problem that caused a small fraction of the implanted devices to short-circuit.

The admission by Indianapolis-based Guidant Corp., first reported Tuesday by The New York Times, came about after a Minnesota college student died on a spring break bicycling trip in March.

The death of 21-year-old Joshua Oukrop, who had a genetic heart disease, is the only one known.

Guidant disclosed the flaw in its Ventak Prizm 2 Model 1861 to Oukrop's doctors and told them about 25 other cases in which the defibrillator had malfunctioned, the newspaper reported. It did not, however, issue an alert to physicians until it learned the newspaper was preparing a story on the defibrillator.

Company officials did not return calls seeking comment Tuesday from The Associated Press.

Dr. Douglas Zipes, a heart expert at the Indiana University School of Medicine, said Tuesday even though the risk associated with the malfunction was small, the potential consequences were severe.

Flawed design

"I don't think Guidant can be faulted for a design flaw they did not anticipate," said Zipes, who edits the journal that received the manuscript in which two doctors revealed the flaw. "The issue is, knowing such a defect exists, what do you do about it?"

The company is recommending that the unit not be replaced.

A statement posted Tuesday on Guidant's Web site said the unit "continues to exceed design expectations and ranks overall as one of the most reliable [defibrillator] products available."

Guidant had not seen a compelling reason to issue an alert to physicians because the malfunction rate was low and replacing the devices might pose greater patient risks, Dr. Joseph M. Smith, a Guidant executive, told the Times.

"We choose to extraordinarily communicate when we have a product that does not live up to our expectations," Smith said, adding issues that could improve patient outcomes would also warrant an alert to doctors. "In this case, neither condition was met."

Electrical malfunctions involving the model occurred in units produced during a two-year period before mid-2002, when the company fixed the flaw, the Times reported. The problem has not happened in any devices made since.

In February, Medtronic Inc. told doctors that the battery used in one of its defibrillators was draining too fast. No deaths or injuries have been associated with the Medtronic model.

Oukrop's father, Lee Oukrop, who has the same genetic heart disease, had the same defibrillator until last week, when he underwent a replacement procedure.

"Whoever made this decision at Guidant, I pray he doesn't have a son who this happens to," Lee Oukrop told the Times.

Shares of Guidant were down 50 cents, or 0.67 percent, at $73.73 in late morning trading Wednesday on the New York Stock Exchange.

John Putnam, an analyst and senior vice president with Stanford Financial Group in Boca Raton, Fla., said he did not think the news would have a major impact on Guidant's stock or its pending $25.4 billion merger with Johnson & Johnson.

Putnam said it was "unfortunate" Guidant had not disclosed the problem to patients previously. But, he said, "All companies have problems from time to time. That's kind of the nature of the beast."

Guidant is one of the largest makers of medical devices, with $3.8 billion in sales last year, almost half coming from implantable defibrillators.


On the Net:

http://www.guidant.com/


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