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Texas woman files Sprint Fidelis lawsuit over 'frightening episodes'
Thursday, 13 August 2009
A Texas woman has filed a lawsuit against the manufacturers of the defibrillator lead wires that she alleges caused her to receive painful, unnecessary shocks to her heart. Cheryl Fisk’s Sprint Fidelis lawsuit against Medtronic Inc. and its affiliated companies alleges that the lead wires are “unreasonably dangerous” because of an increased risk of breaking after they are surgically implanted.

Sprint Fidelis lead wires are attached to a defibrillator that is implanted internally in patients with certain heart problems. The defibrillator sends electrical shocks through the Sprint Fidelis leads in order to restore the heart’s normal rhythm.

Medtronic issued a recall of the Sprint Fidelis lead wires in October 2007 after reports emerged that the wires could fracture after they are implanted, causing a defibrillator to deliver repeated shocks to the heart. According to the consumer advocacy group Public Citizen, the Food and Drug Administration received nearly 600 reports of side effects or injuries concerning the Sprint Fidelis leads before the recall notice was issued. More than 200 of these reports involved patients who had received unnecessary shocks to the heart.

According to her lawsuit, Fisk was implanted with a defibrillator that used the Sprint Fidelis leads in January 2006. She alleges that her defibrillator delivered several shocks to her heart during several “frightening episodes” which required her to undergo additional medical care.