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Medtronic Recall: Heart Lead / Defibrillator Wires Recalled: Emerging Class Action Lawsuit

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Medtronic Recall: Heart Lead / Defibrillator Wires Recalled:	SPREAD THE WORD

| 158 |      LEAD PLAINTIFF:       Case Filed: 2008-03-17

Case Summary: In lawsuits against Medtronic the plaintiff allege that Medtronic misrepresented the safety of the Sprint Fidelis leads and they suffered massive, unnecessary electrical shocks. Hundreds of injuries linked to Sprint Fidelis heart defibrillator wires were reported to the Food and Drug Administration last year. The FDA had received 599 reports of malfunctions and injuries associated with the Fidelis leads as of January 10, 2007, including 204 where patients had been inappropriately shocked. The high and early failure rate of Medtronic Sprint Fidelis leads was also reported in a medical journal in 2006. Yet, Medtronic failed to issue a recall and instead continued to sell the devices. Medtronic has not disclosed the precise mechanism of the Sprint Fidelis lead fracture failures. The complaints allege that the defect is attributable to the small diameter of the coil and conductors in the lead which make it prone to stress damage both during and after implant surgery. Fracture eventually occurs when the conductor is critically overstressed. Case Detail: On October 15, 2007, due to reports of at least five patient deaths associated with the defibrillator leads, Medtronic issued a recall of the product. The recalled leads have been implanted in over 200,000 patients since 2004.

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