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Medtronic Suspends Trials of Heart Device.(Originated from Saint Paul Pioneer Press, Minn.)
Knight Ridder/Tribune Business News, September, 1997 by Wieffering, Eric
Sep. 18--Medtronic Inc. has temporarily suspended implanting its next generation heart device because of quality control problems with an electrical component.
The Gem DR was in clinical trials in Europe and had been implanted in fewer than 10 people, none of whom has reported problems with the device, said Medtronic spokesman Dick Reid.
Medtronic discovered the problem when a component in a charging circuit failed during routine production testing. "One device came along that failed the test, so we shut down production and suspended the trials," Reid said.
Medtronic said it is fixing the problem and expects to resume clinical trials in mid-November.
The decision whether to remove the implanted devices has been left...
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