In the past year, hundreds of injuries linked to the Medtronic's Sprint Fidelis leads were reported to the Food and Drug Administration (FDA). Manufactured by Medtronic, Inc., Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur. Despite reports of injuries and unnecessary electric shocks caused by the Spring Fidelis leads, Medronic did not recall the dangerous product until October of 2007, when approximate 268,000 people had Sprint Fidelis leads implanted and there were 5 deaths reported. The recalled models of the Sprint Fidelis lead are :
The reason for the recall, according to the FDA is "because of the potential for lead fractures. These electronic wires are prone to fracture in a small number of patients. This could cause the defibrillator to deliver unnecessary shock or to not operate at all. Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis lead may have been a possible or likely contributing factor."
It should be noted that patients who already have the Sprint Fidelis lead are not advised to undergo surgery to remove the fractured lead, but rather to have it monitored closely, or to have the lead capped and another model implanted. Patients who do not know if they have the Medtronic Sprint Fidelis lead should contact their physician. It must be noted that the dangerous leads were also used in defibrillators that were not manufactured by Medtronic.
It is estimated that 2% of patients with the lead with experience lead fracture within 30 months. Consequently, Medtronic will cover the cost of defective leads and will provide up to $800 for medical expenses not covered by insurance. However, as of yet, the company refuses to pay to replace leads that have not yet malfunctioned, so patients worried about their safety, due to the potential danger of the Sprint Fidelis Lead, will have to pay for their own surgery or hope that their lead does not malfunction.
Medtronic Spring Fidelis lead cases allege that the safety of the leads was misrepresented by Medtronic, who manufactured and marketed a defective medical product that lead to shocks, injury, and in some cases, death.