Medtronic Defibrillators

In October, 2007, the FDA issued a statement regarding Medtronic's voluntary recall of their Sprint Fidelis Defibrillator Leads. This statement, issued by Daniel Shultz, M.D., Director of the Center for Devices and Radiological Health, said "Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety."

Defibrillators are implanted devices in patients with abnormal heart rhythms that can cause the heart to suddenly stop. These defibrillators deliver shocks to get the patient's heart back to a normal rhythm through pulses of energy through the leads (electronic wires.)

The Medtronic Sprint Fidelis defibrillation leads can cause the defibrillator to malfunction and give random shocks, or not function at all. At least five deaths have been reported due to these leads. Additionally, in 2005, Medtronic issued a press release warning physicians of a potential battery shorting mechanism that may occur in some of its models. The press release stated

• "If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function."
• "Potentially affected models are the MarquisT VR/DR and MaximoT VR/DR ICDs and the InSync I/II/III MarquisT and InSync III ProtectT CRT-D devices. Approximately 75 percent of these devices were implanted in the United States."

If you or someone you care about has used Medtronic Defibrillators and suffered a serious injury or death, please fill out our Case Review Contact Form to the right on this page to find out what your case is worth.

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