October 15, 2007—Medtronic announced a recall of its Sprint Fidelis defibrillator leads after numerous reports of device failures leading to serious injuries and at least five deaths. An estimated 235,000 people have been implanted with the Medtronic Sprint Fidelis leads.
Leads are used to link a defibrillator or pacemaker to the patient's heart. Medtronic reports that the device can fracture after implantation, delivering a painful and potentially deadly electrical jolt to the patient.
Medtronic estimates that 2.3% of patients with these affected leads will experience failure within 30 months of implantation. Those people whose devices fail face a risk surgical procedure to remove the defective leads. Most patients who received Medtronic defibrillators since 2004 have the defective Sprint Fidelis leads.
Patients with Medtronic defibrillators should refer to their Patient ID card to determine whether the leads for their device are affected by the recall. The recall includes the following models:
- Model 6930
- Model 6931
- Model 6948
- Model 6949