Guidant Confirms It's Working Qith FDA on Defibrillator ProblemMay 25, 2005 | AP
Medical device maker Guidant Corp. confirmed Wednesday that it is cooperating with the Food and Drug Administration as the agency looks into why Guidant waited three years before disclosing a problem with one of its heart defibrillators.
In a statement, Guidant said it "will continue working with the FDA on this issue, including any subsequent communication that may be helpful for patients or physicians."
The FDA is investigating why Guidant did not issue an alert to some 24,000 patients and their doctors about its Ventak Prizm 2 Model 1861 until three years after learning of an electrical problem that caused a tiny fraction of the devices to short-circuit.
Guidant did not issue the alert until Tuesday after learning that The New York Times was preparing a story on the problem with the implantable device.
Implanted defibrillators shock the heart back into a normal rhythm when it starts beating irregularly.
The Times reported Tuesday that a Minnesota college student who received the implant for a congenital heart problem died on a bicycling trip in March after it short-circuited.
Although Indianapolis-based Guidant told 21-year-old Joshua Oukrop's doctors about the flaw and about 25 other cases in which the defibrillator had malfunctioned, it did not issue an alert to physicians until learning of The Times' report.
None of the 25 other known short-circuits resulted in a patient's death.
Guidant had identified one similar failure in 2002 and reported it to the FDA, said company spokeswoman Annette Ruzicka.
FDA spokeswoman Julie Zawisza said Wednesday the agency has discussed the problem with Guidant, but would not elaborate or say how long the review would take.
Zawisza said the FDA helped Guidant draft the statement it released Wednesday.
"We typically tell the company that it's a good idea for them to prepare this kind of communication, and we encourage them to do that because if they don't, we also have the option to do it," she said.
"In this case we did offer our assistance and we did provide some help to them for the press release they wrote."
Ruzicka said the statement contains no new information.
"It just confirms that we're working with the FDA on the issue," she said.
Guidant, which is not recommending that the devices be replaced, said Tuesday the defibrillator "continues to exceed design expectations" and ranks overall as one of the most reliable defibrillators available.