For people suffering from cardiac dysrhythmias and ventricular fibrillation, defibrillators can be lifesaving tools. However, the men and women who received defibrillators with Sprint Fidelis leads are at risk of experiencing painful shocks due to potentially deadly malfunctions. As a result, many have filed suit against Medtronic, Inc. (MDT).
What Is the Sprint Fidelis?
MDT's Sprint Fidelis family of heart leads are thin insulated wires that were previously used for patients with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) designed to stop deadly heart rhythm disruptions. They were not used in pacemakers, which are designed to maintain proper heart rhythm by providing lower voltage stimulation.
About 268,000 of the Sprint Fidelis leads were implanted in patients around the world. However, the Sprint Fidelis leads were formally recalled on October 15, 2007.
Problems Associated With the Sprint Fidelis
Sprint Fidelis leads were recalled because of the potential for a lead fracture that would result in the defibrillator either failing to operate at all or delivering an unnecessary shock to the patient. At the time of the recall, it was estimated that 2 percent of patients would experience a lead fracture within 30 months of receiving the Sprint Fidelis lead. However, according to research published in the US National Library of Medicine, younger and healthier patients were at the greatest risk of a malfunction simply because they’d require the devices for the longest period of time. After five years, 20 to 30 percent of patients reported lead-related complications.
Patients who have experienced unnecessary shocks after a Sprint Fidelis lead fracture have compared the experience to being kicked in the chest by a horse or hit by a car. One man reported the force of the shocks he received from the malfunctioning device was strong enough to throw him across the room of his home. The shocks from malfunctioning leads happen irregularly but can occur 50 times an hour.
In addition to the physical pain of being shocked, patients with malfunctioning Sprint Fidelis leads have reported depression, anxiety, and fear. Many claim they are so afraid of unnecessary shocks, they're unable to fully enjoy the activities of daily living.
There have been 13 confirmed patient deaths from Sprint Fidelis heart leads. Four of these patients died as a result of the risky surgical procedure used to remove the leads from the chest. As a result, doctors advise patients with the Sprint Fidelis leads to avoid surgical removal of leads that aren't malfunctioning. However, a number of patients have had new leads implanted when their defibrillators were being replaced or had additional leads added while leaving the Sprint Fidelis leads in place.
What Settlements Have Been Reached?
Plaintiffs pursuing litigation against Medtronic claim the company was negligent in manufacturing and marketing a defective medical device. They allege the company knew of the potential for serious injuries or death from the Sprint Fidelis leads several months before issuing the recall.
In 2010, MDT reached an agreement to settle over 8,000 personal injury cases for $268 million. The settlement covered both state and federal court cases. Plaintiffs were compensated based on the severity of their injuries, with plaintiffs representing deceased patients or those who had major complications after having the device removed receiving the largest sums. However, MDT did not admit any liability for injuries caused by the devices, and plaintiffs in the case did not acknowledge that the company had any valid defense to their Sprint Fidelis-related injury claims.
Am I Eligible for Compensation?
The affected patients in the MDT litigation were implanted with Sprint Fidelis model numbers 6930, 6931, 6948, and 6948. To be potentially eligible for compensation, you must have been implanted with one of these models and experienced a lead fracture, capped wire, or wire replacement.
Neblett, Beard & Arsenault is committed to helping those who experienced Sprint Fidelis lead malfunctions protect their legal rights. To learn more, schedule a free consultation at one of our six office locations.