San Francisco Chronicle, "FDA: Defibrillator Defects on the Rise"

          Malfunctions in implanted heart defibrillators were on the rise even before this summer's massive recall by Guidant Corp., government and Harvard University scientists reported Friday.
          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. The deaths represent only a fraction of the more than 400,000 defibrillators implanted during those years, but a troubling number nonetheless as regulators grapple with 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, and points out the need for our agency to improve the way it regulates these products, and we are doing just that," said Dr. Daniel Schultz, FDA's medical device chief.