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The leads, which connect defibrillators to the heart can short circuit resulting in death. Analysis of the U.S. Food and Drug Administration’s safety database linked about 133 deaths to lead malfunctions. Short circuits in St. Jude’s Riata leads are linked to 22 deaths.
Silicone insulation, used on older Riata wires, has been known to cause failure at a rate of 3 to 10 percent. St. Jude stopped selling the leads in December 2010. According St. Jude spokeswoman Amy Jo Meyer, “We continue to study the performance of our older generation silicone leads through the Riata Lead Evaluation Study that was initiated at the end of last year and will communicate the findings from this study as soon as they become available”. The wires remain in about 79,000 patients.
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