By LAURAN NEERGAARD. The Associated Press

09/17/2005 - Malfunctions in implanted heart defibrillators were on the rise even before this summer's massive recall by Guidant, government and Harvard University scientists reported yesterday.

About 20 of every 1,000 defibrillators implanted are malfunctioning, and defects led to 31 deaths between 1990 and 2002, concluded research sponsored by the Food and Drug Administration (FDA).

The deaths represent only a fraction of the more than 400,000 defibrillators implanted during those years, but a troubling number nonetheless as regulators try to figure out how to better ensure the safety of hard-to-replace devices.

Despite the defects, defibrillators "have saved many lives and the benefits of the devices clearly outweigh the risks," said Dr. Scott Gottlieb, an FDA deputy commissioner.

But, the study "does alert FDA that there is a trend that needs to be addressed," said Dr. Daniel Schultz, FDA's medical device chief.

The study came as the FDA and cardiac specialists opened a daylong meeting yesterday to discuss safety problems with implanted defibrillators and pacemakers, and how to decide which patients need to have the devices surgically replaced when manufacturers learn some parts might fail.

That can be a tough balancing act: Failures are rare, and ways to predict whose implant will fail don't always exist, while surgery to remove and replace the implant is risky.

Indeed, some physicians complained they don't have all the information they need to make those decisions. "We've gotten no real guidance from industry, the FDA or the academic community about when to [take the devices out]," said Eric Prystowsky, director of the Clinical Electrophysiology Laboratory at St. Vincent Hospital in Indianapolis. "We're told to use our judgment, but there's huge confusion."

The topic is of growing public concern, because since January, the nation's three leading defibrillator makers - Guidant, Medtronic and St. Jude Medical - have issued recalls or safety warnings affecting more than 200,000 defibrillators.

Guidant has come under fire after acknowledging that it waited three years before alerting doctors and patients about an electrical defect with one of its recalled models linked to two deaths. The company recalled 109,000 devices in June after finding they could develop an internal short-circuit without warning.

The study, conducted for the FDA by Dr. William Maisel, a Harvard Medical School professor, found that from 1990 to 2002, there were 2.25 million pacemakers and almost 416,000 implanted cardiac defibrillators, or ICDs, put in in the United States. More than 17,000 - 8,834 pacemakers and 8,489 ICDs - were surgically removed because of confirmed malfunctions, Maisel found.

Eighty percent were device hardware problems, such as with electrical connections.

More disconcerting than the number, the FDA said, was the trend: In the mid-1990s, some 7.9 ICDs per 1,000 implants were replaced because of malfunctions. That rose to a high of 38.6 per 1,000 implants in 2001 before dropping slightly to a rate of 20.7 the next year.

More than half of the malfunctions occurred during the study's last three years.