The company issued the recall after it received several reports of fractures in the Sprint Fidelis leads. The fractures can cause the lead to send false signals to the defibrillator; this can cause the defibrillator to deliver unnecessary shocks or to not to pace or shock when needed. In some cases, the fractures can cause the defibrillator to stop operating. This puts the patient at risk of injury and wrongful death.
Medtronic has reported that at least 13 patient deaths from the defective medical device and other major complications have occurred after the leads have fractured. However, as many as 3 times more deaths are alleged to be associated with a Medtronic Sprint Fidelis defibrillator leads. In addition, the extra shocks are very painful even when there is no lasting harm.
The following models of Sprint Fidelis Leads have been recalled because they are at risk or fracture:
• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949
These leads were implanted in more than 268,000 patients. While Medtronic has asked doctors to stop implanting the leads and return all unused leads to Medtronic, they will not pay for procedures to replace functioning leads that patients want taken out to head off potential problems. This means that thousands of patients may still experience a lead fracture.
Patients are advised to consult their doctors regarding their defibrillator leads; if a Sprint Fidelis defibrillator lead was used, they should discuss the best course of action to protect their health.
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