Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: TUESDAY, February 14, 1995                   TAG: 9502150008
SECTION: EXTRA                    PAGE: 6   EDITION: METRO 
SOURCE: SALLY SQUIRES THE WASHINGTON POST
DATELINE:                                 LENGTH: Medium

WARNING ISSUED ON PACEMAKERS

The faulty pacemaker wires, or leads, have been linked to two patient deaths and has caused medical problems in seven others.

The faulty pacemakers are equipped with Accufix atrial ``J'' wires (models 330-801 and 329-701), according to the FDA. They were implanted in patients in the United States from 1988 to 1994. An estimated 12 percent of the wires may be defective, said Larry Wettlaufer, a spokesman for the manufacturer, Telectronics Pacing Systems of Englewood, Colo. About 40,000 patients have received the pacemakers with these wires.

Last month, the company sent letters to physicians recommending that all their patients who had the pacemaker lead wires undergo fluoroscopy, a type of X-ray that enables doctors to view the beating heart.

At the same time, the FDA issued a talk paper advising physicians and patients about the problem. People who are believed to have the faulty lead should receive letters this month from Telectronics. Those notices will warn of the possible problem and urge that patients get in contact with their physicians for follow-up.

Testing will be paid for by Telectronics. Company officials also said that if the wire leads are found to be defective, Telectronics will pick up any cost of replacement not covered by health insurance or Medicare.

FDA officials emphasized, however, that most of the more than 1 million people with pacemakers will be unaffected. ``This really affects a small percentage of people, about one of 40 who have pacemakers,'' said Susan Alpert, director of the agency's division that reviews new medical devices.

The defect does not disable the pacemaker itself, but involves fracture of a wire used for holding another wire that goes into the heart. In some cases, the fractured wire has been able to work through a protective polyurethane coating, enabling the wire to flail around and perforate the heart. This in turn can cause great damage and, in the worst case, death.

``If a fractured wire is detected, doctors can decide to replace it or leave it in place and monitor it on fluoroscope or X-ray,'' the FDA advised in a statement released last week. ``Most fractured wires are not medical emergencies.''

Replacement is done under local anesthesia and generally involves an overnight stay in the hospital.

People who are uncertain whether they may have the pacemaker lead wire can pursue two options, FDA officials said. One is to check the card that every pacemaker patient is given when the devices are implanted, which shows which kind of pacemaker they have, Alpert said. ``But if they are unsure or concerned,'' she said, ``they ought to call their own doctors to be sure.''