Medical Device:

St Jude Defibrillators

In November 2007 reports surfaced that St. Jude Riata Defibrillator Lead wires had punctured the hearts of some patients. In one case, the defective wire nearly broke through the patient’s skin.

When a defibrillator lead wire detaches from the heart, the medical device fails to emit electrical shocks to the heart, putting the patient at risk for death. If the detached St. Jude Defibrillator Lead pierces heart tissue, it can bleed into the pericardial sac around the organ. This may lead to a potentially life-threatening condition where pressure builds around the heart, preventing the organ from beating correctly.