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Medtronic could face 1,000+ lawsuits over recalled wires
Thursday, 18 October 2007
Financial experts say that Medtronic could face more than 1,000 lawsuits over the recall of a metal wire used with the company’s defibrillators. Carol Levenson, an analyst with the financial website Gimme Credit, predicts that the company could face even more lawsuits over the recalled Sprint Fidelis lead wire than the 1,000 that have been filed over a 2005 recall of Medtronic defibrillators. At least five Medtronic lawsuits have been filed against the company since the recall of the company's Sprint Fidelis leads was announced on October 14. These defibrillator lawsuits have alleged that broken lead wires in the patients’ defibrillators caused the devices to deliver repeated, unnecessary shocks to their hearts.

Medtronic says that it has received reports of five patients who have died after experiencing defibrillator wire problems due to broken Sprint Fidelis leads. The Food and Drug Administration has received at least 1,600 reports of injuries or malfunctions in Medtronic defibrillators due to fractured Sprint Fidelis lead wires; of this group, about one-third may have involved excessive shocks from the device.

Experts say that the Sprint Fidelis lead wire is prone to fracture about twice as often as other lead wire manufactured by Medtronic. Although the Medtronic recall for the lead wires was issued this week, the company has indicated that it was aware of potential problems with the device as early as March, but delaying in issuing a recall until now.