Defibrillator-Maker Kept Silent About DefectMay 25, 2005 | AP
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 devices to short-circuit.
The admission by Indianapolis-based Guidant Corp., reported Tuesday by The New York Times, came after a Minnesota college student died on a spring-break bicycling trip in March.
The death of Joshua Oukrop, 21, 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 Times 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.
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."
"I don't think Guidant can be faulted for a design flaw they did not anticipate," said Dr. Douglas Zipes, a heart expert at the Indiana University School of Medicine. Zipes 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.
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.
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.
Guidant is one of the largest makers of medical devices, with $3.8 billion in sales last year, almost half coming from implantable defibrillators.