FDA Was Warned About Heart Devices

Months before the US 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. Citing agency records, The New York Times reported that the federal agency did not make that data public at the time because it treats the information it receives in such reports as confidential. While the FDA 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, the report said Monday. As part of a lengthy annual report that Guidant submitted to the FDA 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, according to The Times. A month later, a college student who had one of those units implanted in his chest died of sudden cardiac arrest, the paper said. In June, the FDA issued an alert about the model, later updating it to say that the short circuits posed a significant risk because they could render the device useless just when it was needed most, according to the report. Defibrillators use jolts of electricity to stop erratic heart rhythms, which can be fatal.