FDAnews
www.fdanews.com/articles/73524-fda-warns-medtronic-over-lifepak-defibrillators

FDA WARNS MEDTRONIC OVER LIFEPAK DEFIBRILLATORS

June 21, 2005

The FDA has issued a warning letter to Medtronic over its manufacturing practices for its Lifepak 12 external defibrillator, saying the company's Medtronic Emergency Response Systems unit failed to properly correct broken pins in therapy cables for the devices.

The FDA said it first found manufacturing problems at the Seattle, Wash.-based unit in February and March. Medtronic took action to fix the cable problem in the devices, which are used by health professionals to try to restore normal heart rhythms, but the FDA said the problem still persists.

Medtronic said in April and May it would continue to investigate the problem, but it has failed to make any attempts to find out why the repair efforts were flawed, the warning letter states. Earlier this year, Medtronic recalled another version of the device, the Lifepak 500, because of an electrode connection issue.