The Food and Drug Administration said the rate at which implantable cardioverter defibrillators were removed from patients because of malfunctions increased between 1990 and 2002, but the rate of pacemaker removals fell.
Over half of the ICD removals occurred in the last three years of the study. The FDA said the higher rate of ICD malfunctions could reflect the increased complexity of the devices or better reporting by doctors. The agency concluded that careful monitoring of device performance is needed, as well as better ways for doctors to return removed devices and report adverse events.
Physicians reported removing 8,834 faulty pacemakers out of about 2.25 million pacemakers implanted in the U.S. during the 12-year period and 8,489 ICDs out of about 416,000 implanted.
Pacemaker or ICD malfunctions were responsible for 61 confirmed deaths during the period, the FDA said.