"Implanted cardioverter defibrillators, or ICDs, and pacemakers were "directly responsible" for 61 deaths out of nearly 3 million implants between 1990 and 2002, according to a Food and Drug Administration report released on Friday.

Those deaths were ones that had been linked to a malfunctioning device that was removed and checked by the manufacturer, it said.

Defibrillator malfunctions dipped in the mid-1990s but rose since 1999, after which more than half occurred, it also found.

"The results demonstrate a marked increase," William Maisel, a Boston-based cardiologist and an FDA consultant, said at a Washington meeting of cardiologists.

The study said the reasons for the increase were unclear, but could be due to the devices' growing complexity, or more physician reports.

The event, sponsored by the Heart Rhythm Society, focused on how to better monitor and report problems. The group represents doctors who deal with irregular heartbeats, which can be treated with devices that shock the heart to normal rhythms.

It will eventually make formal recommendations for change, but said the process could take months or longer.

The last two years has seen thousands of recalled heart devices. Current makers include Guidant Corp., Medtronic Inc. and St. Jude Medical, Inc..

A debate erupted earlier this year after it was disclosed that Guidant did not make public for three years a potential problem with some ICDs.

FDA officials said their review, which analyzed yearly reports submitted by companies from 1990 through 2002, was an attempt to be more forthcoming.

Pacemaker problems since 1990 have dropped, they also found, to a mean annual rate of 4.6 replacements per 1,000 implants compared with 20.7 per 1,000 for defibrillators.

Irregular heartbeats, or arrhythmias, are common, and medication are also used as treatments. A procedure using radio frequency to destroy problematic heart tissue also may help.

Daniel Schultz, head of the FDA's device center, said it was "too soon" to determine the agency's specific next steps.

At the meeting, experts debated how much information device makers and the FDA should release and when.

"Public communication of advisories has an adverse impact on unaffected and potential patients," said Tim Samsel, head of regulatory affairs for Medtronic's cardiac rhythm unit who argued information should come from doctors.

Advocate Lisa Salberg said patients should also hear about problems directly from companies and the FDA.

Some questioned if the agency had enough resources.

"I think the FDA can do a better job," said Thomas Gross, head of post-market device surveillance at the agency. "There are gaps in the system."

One such gap is getting devices returned when there is a problem, or even death. Some called for a new system requiring all such devices to be registered.

Many panelists recognized the industry's tarnished image but argued that the devices' benefits outweighed any risks." Reuters.co.uk