Medtronic Cardiac Device Under Investigation

February 2007

The Food and Drug Administration (FDA) is reviewing claims made by a former Medtronic Inc. engineer that the company didn’t properly test its new Concerto cardiac device. The device is used to resynchronize the heartbeat of patients and provide backup “defibrillator” capabilities during cardiac arrest.

The former engineer claims that Medtronic did not do enough testing on the device’s wireless capabilities, and the tests that were done showed instabilities. The engineer felt these instabilities would prevent other circuits from behaving properly and lead to battery depletion, or burn up other circuits in the device.

In the U.S. alone, 11,000 Concerto devices have been implanted in heart patients. To date, Medtronic has not received any reports of adverse events due to the wireless features of the device.

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