Guidant admits, three years down the line, to a fault with internal heart defibrillator

May 24 2005

In a very belated admission Guidant Corp., has now acknowledged that it's internal heart defibrillator has an electrical problem that caused a small fraction of the implanted devices to short-circuit.

The company has waited three years before telling some 24,000 patients and their doctors about the fault and the admission has only come about following the death of 21-year-old Joshua Oukrop, who had a genetic heart disease. The Minnesota college student died on a spring break bicycling trip in March.

Indianapolis-based Guidant Corp. has 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, but it did not, issue an alert to physicians until it learned the New York Times was preparing a story on the defibrillator.

Heart expert Dr. Douglas Zipes, of the Indiana University School of Medicine, says that even though the risk associated with the malfunction was small, the potential consequences were severe.

Zipes says the company should not be faulted for a design flaw they did not anticipate, but the issue is knowing such a defect exists, what was done about it?

Zipes is the editor of the journal that received the manuscript in which two doctors revealed the flaw.

The company Guidant is now recommending that the unit not be replaced.

A statement on Guidant's Web site says the unit "continues to exceed design expectations and ranks overall as one of the most reliable (defibrillator) products available."

According to Dr. Joseph M. Smith, a Guidant executive, because the malfunction rate was low and replacing the devices might pose greater patient risks they did not feel compelled to issue an alert to physicians.

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