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Medtronic Defibrillator Lead

On October 15, 2007 Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected in a number of patients. This voluntary defibrillator lead recall came after Medtronic identified five patients whose deaths may have been related to a fractured Sprint Fidelis defibrillator lead. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company, according to the Food and Drug Administration (FDA). While the FDA has not suggested or mandated the Sprint Fidelis lead me removed from the more than 268,000 patients who are implanted with the lead, those patients are encouraged to contact their physicians for further information.

Fast Facts

Device name: Sprint Fidelis Defibrillator Lead
Manufacturer: Medtronic
Approved uses: Approved for use in a defibrillator system with a device implanted near the shoulder and one or more leads, or wires, connecting the device to the heart for the purpose of defibrillation in the event of cardiac arrest in those at risk.
Malfunctions: There is a small chance of fractures in particular locations on the Sprint Fidelis lead, which can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life-saving one to a patient in need.
Related topics: Medtronic Defibrillator
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