FDA Knew of Heart-Device Problems Before Releasing Alert: Report

September 12, 2005-- Posted at 2:45 PM CDT

The U.S. Food and Drug Administration received a report last February about problems with implanted heart defibrillators made by the Guidant Corp. but didn't issue a safety alert until June, The New York Times reported Monday.

The report from Guidant contained data showing that one of its most widely used defibrillator models -- the Ventak Prizm 2 DR -- was suffering a short-circuit rate of about one a month. A month after the FDA received the report, a U.S. college student who had this model defibrillator died of sudden cardiac arrest.

Defibrillators are designed to deliver electric jolts to the heart to control irregular heart rhythms.

The FDA didn't make the data public when it received it because the agency treats the information in such reports as confidential, the Times reported. The agency's policy is to review these reports within 90 days of receiving them. However, it's unclear whether the Guidant report was reviewed within this time frame or how FDA regulators first interpreted the data in the report, the newspaper said.

The Guidant controversy prompted a meeting of heart specialists that's scheduled for this Friday in Washington, D.C. One of the major issues expected to be discussed is how much medical device safety data should be disclosed to doctors and patients, the Times reported.

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