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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: Medtronic Recalls

On October 15, 2007, The U.S. Food and Drug Administration (FDA) issued a Class I Recall of Medtronic Sprint Fidelis defibrillator leads due to a fracture risk that can lead to unwanted shocks being applied to the implanted patients heart.

Medtronic advises patients who are implanted with this lead or do not know the model of their lead, to contact their physicians for further information as soon as possible.

A heart defibrillator is used to monitor the patient's heartbeat. If the monitor detects an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal heart beat. The defibrillation system consists of a device implanted near the shoulder with one or more leads that connect the device to the heart.

The leads are recalled due to small number of fractures detected. When the lead breaks, it can cause the defibrillator to malfunction and send inappropriate shocks to the patient's harts or result in loss of therapy.

Sprint Fidelis defibrillation leads included in the recall are Models: 6930, 6931, 6948, 6949