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France Pulls U.S.-Made Pacemakers Off the Market

January 27, 1996

PARIS (AP) _ French pacemaker users filed a lawsuit Friday against Telectronics, an American company they contend made defective devices, and health officials pulled the products off the market.

Three pacemaker users and an association of others are suing Telectronics, alleging its pacemakers have metal wiring that can come out of protective casings and pierce the heart.

In October 1993, Telectronics was implicated in a separate lawsuit over allegations that its pacemakers were defective, French government officials said.

The company’s French representatives say as many as 42,121 potentially defective pacemakers have been sold worldwide, but each carries only a 14 percent risk of a malfunction.

There have been 18 cases in which the pacemaker was confirmed to have been defective. More may have gone undetected because pacemaker users who die do not undergo routine autopsies, French media reports said.

As of mid-January 1996, 342 people have had Telectronics pacemakers removed, the company said. It estimates that 4,900 people in France are fitted with its devices.

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