FDA: Heart defibrillator maker has failed to address device flaw

06/22/2005 | NYTimes.com

The U.S. Food and Drug Administration has warned medical device maker Medtronic that it has not completed requirements to correct flaws in its best-selling Lifepak 12 external defibrillator. The device has had problems with a cable running to paddles designed to deliver life-saving shocks to the people whose hearts have suddenly stopped, and, in a warning letter, the FDA said Medtronic had failed to follow up on reports of continued problems.

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