Long-term studies for pacemaker leads

FDA Consumer, Sept, 1992

Manufacturers, distributors and importers of all implanted pacemaker leads marketed in the United States since Jan. 1, 1982, are being required by FDA to conduct long-term performance studies, because of concern that leads may wear out prematurely, necessitating their replacement.

A pacemaker is a device surgically implanted in the chest that can sense the onset of abnormal rhythm and sends electrical pulses to the heart to maintain a normal heartbeat. The leads are insulated wires that connect the pacemaker with the heart.

The lifespans of the pacemaker leads vary widely. Some last as long as five years, but others wear out sooner.

"These studies will show whether some pacemaker leads have a tendency to wear out prematurely, needlessly exposing patients to the risk of early replacement," said FDA Commissioner David A. Kessler, M.D. "If this is the case, we will ask the manufacturers to take appropriate aCtiOn."

The agency announced this requirement on July 1, 1992. FDA is requiting the studies under a provision of the Safe Medical Devices Act of 1990 that allows the agency to require manufacturers to conduct studies of devices already on the market when necessary to protect public health or to provide needed safety or effectiveness data. About 15 ruins will be involved in the studies.