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.