Medtronic Sprint Fidelis Defibrillator Leads
Motley Rice actively litigated cases involving Medtronic defibrillator patients who suffered from injury or complications involving the Sprint Fidelis® lead component. A fracture in the Sprint Fidelis lead can cause the device to misread heart rhythms, sending unnecessary, painful shocks to patients or worse, the failure to provide a vital life-saving shock.
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.
Sprint Fidelis Lead Defect Announced
On 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 Medtronic, approximately 268,000 patients were implanted with a Sprint Fidelis lead as part of a Medtronic defibrillator since 2004. Affected models of the Sprint Fidelis defibrillator leads are:
- Model 6930
- Model 6931
- Model 6948
- Model 6949
As part of the warning, Medtronic estimated that approximately 4,000 to 5,000 people with the defective Sprint Fidelis lead would experience a lead fracture within 30 months of implantation. 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.