FDA: Defibrillator Defects on the Rise

WASHINGTON - The Food and Drug Administration said Friday that reported malfunctions in implanted cardiac defibrillators have risen sharply over the past decade, even as the lifesaving devices have proliferated — and it urged the hundreds of thousands of patients who carry them not to panic.

In a new report, the FDA said malfunction reports on defibrillators and pacemakers together climbed to a combined 8,300 in the past reporting period — a rate that has grown roughly with the devices' surging popularity.

Implanted defibrillators, which are about the size of a stopwatch and sit under the collarbone, shock the heart back to life when it slips into a lethal rhythm. An estimated 140,000 are now implanted each year in the United States.

The issue burst into public view this year when Guidant Corp. recalled tens of thousands of devices and disclosed that some could short-circuit — and that it had known about one flaw for years while continuing to sell affected models.

Several patients died before their defective units could be replaced, and the disclosures triggered a wave of anxiety among implant recipients, congressional scrutiny and lawsuits.

The FDA emphasized that the overwhelming majority of devices work as designed, and that removing one carries its own surgical risk. "These devices save tens of thousands of lives," an agency official said. "For most patients the risk of removal far outweighs the risk of failure."

The agency is weighing tougher oversight, including mandatory reporting of all device malfunctions — much reporting is now voluntary — and clearer guidance on when a flaw requires a recall rather than a quiet correction.

Doctors say patients with questions should call their cardiologist, not the emergency room. "The right answer for nearly everyone is to keep the device and have it checked on schedule," one heart specialist said.