Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: WEDNESDAY, August 23, 1995 TAG: 9508230067
SECTION: NATIONAL/INTERNATIONAL PAGE: A-9 EDITION: METRO
SOURCE: Associated Press
DATELINE: WASHINGTON LENGTH: Medium
Recommendations from the manufacturer will be going out to the doctors of 25,000 Americans who had the wires implanted in their chests and now must decide what to do about it.
According to the Food and Drug Administration, 1,717 Americans have had the wires surgically removed since the risk was announced in January. Four died from the procedure. Twenty-six others suffered injuries but recovered, some after emergency open-heart surgery, FDA figures show.
The manufacturer, Telectronics Pacing Systems, studied patients with the potentially faulty Accufix ``J'' lead to determine who needs the wire removed and who should leave the part alone. Telectronics has promised the FDA it will release the information in a few weeks.
The FDA says removing the wire should be a last resort.
The agency cannot tell how many of the extractions already performed were medically necessary. But ``most of the patients who died while having extractions actually had normal leads,'' said medical officer Dr. Stuart Portnoy.
The Accufix wire is a J-shaped hook used to implant an electrical coil that sends shocks to a pacemaker to keep a diseased heart beating regularly. Once the pacemaker is implanted, this hook is no longer important to the device's functioning.
But the hook can break, popping out of its plastic coating and puncturing the heart wall. That has killed at least two people. The Accufix was recalled last year, and in January the FDA recommended that patients who already have the wire undergo special X-rays to see if theirs appear ready to break. Only those at high risk were advised to have the wire removed.
by CNB