NYTpg1: FDA Had Report of Short Circuit in Heart Devices (delayed release)

[DeepModem Mom]

F.D.A. Had Report of Short Circuit in Heart Devices
By BARRY MEIER
Published: September 12, 2005


Months before the Food and Drug Administration issued a safety alert in June about problems with Guidant Corporation heart devices, the agency received a report from the company showing that some of those units were short-circuiting, agency records obtained by The New York Times show.

But the agency did not make that data public at the time because it treats the information it receives in such reports as confidential. While the agency has a policy of reviewing the reports within 90 days, it is unclear when regulators did so within that time frame or how they first interpreted the information.

As part of a lengthy annual report that Guidant submitted to the F.D.A. in February, the company disclosed data showing that one of its widely used defibrillators, the Ventak Prizm 2 DR, was short-circuiting at the rate of about one a month, a rate that some doctors say was troubling. A month later, a college student who had one of those units implanted in his chest died of sudden cardiac arrest.

In June, the F.D.A. issued an alert about the model, later updating it to say that the short circuits, while rare, posed a significant risk because they could render the device useless just when it was needed most. Defibrillators use jolts of electricity to stop erratic heart rhythms, which can be fatal.

Guidant, which knew about the model's flaw for three years but did not tell physicians about it until May, has recently found itself in the spotlight. But the disclosure that the F.D.A. also had data that might have alerted doctors is likely to increase scrutiny of the agency's policy of not releasing the information it requires heart device makers to submit, as well as how quickly it reviews such reports....


http://www.nytimes.com/2005/09/12/business/12fda.html