Medtronic Defibrillator Leads
Medtronic Inc. has removed its Sprint Fidelis defibrillation leads from the market after five patient deaths have been linked to the devices. Medtronic said that the defibrillator lead can fracture and may have been a contributing factor in the deaths. A fracture in the defibrillator lead can cause a defibrillator to deliver unnecessary shocks to the heart or not operate at all.
Defibrillators are used to regulate a persons heartbeat. The device can sense an abnormal heart rhythm and then deliver an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart. Medtronic has begun asking doctors to stop implanting the leads and return all unused leads to Medtronic.
The Following Medtronic Sprint Fidelis Leads were recalled:
Sprint Fidelis 6930
Sprint Fidelis 6931
Sprint Fidelis 6948
Sprint Fidelis 6949
On October 14, 2007, Medtronic, the nation’s largest heart implant device manufacturer, announced a defect in the critical electrical “lead” component of its heart defibrillator. The New York Times reported on October 15, 2007, that the defect in this electrical wire, called the Sprint Fidelis, has resulted in hundreds of malfunctions and may have played a role in the death of five Medtronic defibrillator patients.
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