In 2007, Medtronic Inc. agreed to remove Sprint Fidelis leads associated with defibrillators off the market. The recall included model numbers 6930, 6931, 6948 and 6949. Shortly after the technology entered the market in 2004, the manufacturer and the FDA began receiving complaints concerning the wires. However, the company withheld this information from the public. Other defibrillators also utilize the wires besides the device constructed by Medtronic.
An estimated 268,000 patients have received implanted defibrillator devices utilizing Sprint Fidelis leads. At least 150,000 patients continue life with these implanted and possibly defective wires. The device, technically known as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D), contains the life saving technology within a metallic box the size of a matchbox. Physicians surgically insert the unit under the skin towards a patient’s shoulder area. Surgeons carefully thread fine silicon coated leads from the device, through a vein, positioning the wires into the heart. When a cardiac patient develops an unnatural rhythm or suffers cardiac arrest the defibrillator detects the anomaly and delivers an electrical current to the heart, correcting or restarting the rhythm.
Sprint Fidelis Lead Malfunction
Physicians soon discovered a disturbing trend in which wire fractures occurred after two years. Studies indicate the lead failure rate increases with the age of the wires. The lead malfunction causes the defibrillator to respond in one of three ways:
- Device sends an audible signal alerting patients a system malfunction occurred.
- System incorrectly evaluates disconnected signals as a symptom of dysrhythmia and initiates unnecessary electric current to the heart.
- The disconnection drains the battery, rendering the defibrillator inactive, leaving patients unprotected.
Medtronic claims that 95.4% of the Sprint Fidelis leads had a life expectancy of three years and that the failure rate was 4.6%. Suspicions rose concerning the findings when information revealed researchers involved in the study received grants or consultation fees from Medtronic. Reputable medical facilities including the Mayo Clinic and the University of Rochester in New York found the failure rate to be at least twice that cited by Medtronic. Research conducted as recent as Feb. 2010 reveals failure rates exceeding 12%.
Patient Trauma and Surgical Revision
To date, over 100 deaths occurred because of lead malfunction. Fatalities resulted as patients received excessive amounts of unnecessary electrical current or defibrillators did not respond to a cardiac arrest. Patients receiving inappropriate electrical stimulation report the experience is extremely excruciating.
Cardiac surgeons are reluctant to remove defective leads due to increased surgical complications. Following lead insertion, the body naturally develops scar tissue around the wires. Physicians report this situation elevates surgical risks by over 19%. Lead extraction causes bleeding and tearing at the site of the scar tissue. In some instances, the bleeding proves to be fatal.
If you or someone you love was injured or killed because of a defective product such as the lead malfunctions in the Sprint Fidelis device, contact our office for a free evaluation. We will help you understand your rights and help you decide if you should pursue a claim for compensation because of the defective device.