Medtronic Sprint Fidelis recall: Defibrillator lead could fracture
Medtronic, a global manufacturer of heart devices, suspended sales of their Sprint Fidelis defibrillator lead wire this week. The leads could be a part of any defibrillator system implanted since 2004. Defects could cause the wire to fracture or break, resulting in a severe shock or preventing the device from working when it is needed.
>>INFORMATION: Medtronic Sprint Fidelis Recall Lawsuits
Approximately 268,000 Medtronic Sprint Fidelis leads have been implanted in people throughout the world. According to reports, if the current failure rate of 2.3% continues, approximately 4,000 to 5,000 people could experience a lead fracture during the first 30 months after the device is implanted.
A defibrillator is a small device implanted into the chest of people who are at risk for a cardiac arrest. If the heart beats improperly, the device delivers an electrical shock designed to restore heartbeat to a normal rhythm. The Medtronic Sprint Fidelis lead is attached to the defribillator and carries the current from the device through the patient’s veins to the heart.
Defibrillator leads are very fragile, and the Medtronic Sprint Fidelis which has been recalled is a newer type of lead which is designed to be very thin for easy insertion. Serious and potentially fatal injuries could be caused by a fractured lead. Three potential events could occur if the lead fails:
- Audible Alert: device could make an audible alert of a potential failure
- Sudden Shock: a severe and painful electrical jolt could be delivered even though it is not needed
- Battery Depletion: the battery could die, causing a potential failure if the life saving electrical shock is needed to restore the normal heart rhythm.
The Medtronic Sprint Fidelis recall applies to the following model numbers which will appear on the patient card given after the defibrillator is implanted:
- 6930
- 6931
- 6948
- 6949
Doctors are not recommending the removal of the leads, as risks associated with opening the chest and attempting to replace the wires or add second leads would carry more substantial likelihood for injury than leaving the potentially faulty wires in place. The FDA and Medtronic have recommended that anyone who has a Medtronic Sprint Fidelis contact their doctors.
MEDTRONIC DEFIBRILLATOR LAWYERS
The lawyers at Saiontz, Kirk & Miles, P.A. are reviewing potential Medtronic Sprint Fidelis lawsuits nationwide for individuals who received a defibrillator since 2004. To help determine if you, a friend or family member may have the Fidelis lead and if financial compensation may be available, request a free claim evaluation.
