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Dealing with a sudden onset of arrhythmia, or an irregular heartbeat, can be a frightening experience, especially when the condition can lead to a potentially fatal cardiac arrest. Implantable defibrillators are often used to monitor these fast, abnormal heartbeats by sending an electric shock to the heart when it detects irregular behavior.
Unfortunately, a number of Sprint Fidelis heart defibrillators made by Medronic, Inc. were found to have faulty electrodes—the small wires running to the heart that deliver the shock—that can either misfire at unnecessary times or fail to fire when needed most.
Motley Rice actively litigated cases involving Medtronic defibrillator patients who suffered from injury or complications involving the Sprint Fidelis® lead component.
Motley Rice is no longer accepting Sprint Fidelis cases. If you have a question about the Sprint Fidelis federal multidistrict litigation, contact attorney John Duane by email or call 1.800.768.4026. Fred Thompson, the leader of Motley Rice's Medical team, served on the Plaintiffs Steering Committee for the MDL.
Oct. 14, 2007
Medtronic, Inc., announced a defect in the Sprint Fidelis lead component of its heart defibrillator. The company identified a potentially high rate of fracture of the Sprint Fidelis electrical wires, which can alter the device's ability to accurately read heart rhythms. This defect may cause the device to misfire and shock the patient, or the device may fail to provide a critical, life-saving shock to the patient. The New York Times reported that the defect in this electrical wire has resulted in hundreds of malfunctions and may have played a role in the death of five Medtronic defibrillator patients.
According to the FDA, approximately 268,000 patients were implanted with a Sprint Fidelis lead as part of a Medtronic defibrillator as of 2007. Affected models of the Sprint Fidelis defibrillator leads are:
All patients who have received the Medtronic defibrillator since 2004 are urged to visit their doctor to check for potential fractures.
In conjunction with the announcement, Medtronic recommended that all doctors stop the use of Sprint Fidelis leads in patients using its defibrillators. In addition, Medtronic suspended worldwide distribution and recalled all leads not in use. The Food and Drug Administration (FDA) endorsed the recall.