Defibrillators have made it possible for those suffering from heart conditions to experience a longer, healthier life. There are many different types by many different manufacturers. These internal defibrillators are implanted near the shoulder and contain wires than run to and from the heart. These wires are called leads, and they carry information from the heart to the pacemaker, which will then send a tiny electric shock back to the heart. By doing so, the defibrillator can regulate the rhythm of the patient’s heart without any discomfort or inconvenience.
Medtronic introduced the Sprint Fidelis leads, which offered a more slender lead wire, making them easier to implant during the surgical procedure. These smaller lead wires were approved by the Food and Drug Administration in 2004, and hundreds of thousands of patients have received pacemakers with these leads.
Spring Fidelis Leads Present Complications
Though the thinner wires made implantation of defibrillators easier on the doctors and the patients, the Sprint Fidelis lead wires are prone to fracture. Patients with a defibrillator that has fractured leads report that they receive repeated and unnecessary shocks, or that the defibrillator does not function when a jolt is needed, which interrupts the rhythm of the heartbeat. This can lead to severe complications, including heart attacks. At least five patients have died as a result of the fractured lead wires.
The manufacturer for the Sprint Fidelis leads, Medtronic, estimates that up to 5,000 people may experience fractured lead wires for their Sprint Fidelis pacemakers within thirty months of implantation. Even those that have not yet suffered from fractured lead wires may still find themselves victims of these complications.
Medtronic Lawsuits
There is currently no class action lawsuit pending against Medtronic, and patients are seeking legal representation on an individual basis. The lawsuits have been consolidated in Minnesota, where the headquarters for Medtronic are located. Patients that suffered illness or repeated electric shocks due to the fractured lead wires are seeking compensation for damages that include emotional distress and financial impact.
The lawsuit claims that Medtronic released the Sprint Fidelis lead wires without adequate testing, that the marketing materials contained insufficient warnings about possible malfunction even after several cases were reported, and that patients were not contacted about the possible complications with their pacemakers, though doctors did receive a letter about the possibility of fractured lead wires.
What to Do If You Have a Medtronic Pacemaker
If you were the recipient of the Medtronic Sprint Fidelis leads, but you have not experienced any complications, then potentially you never will. There is still a possibility, however, so it is a good idea to visit your physician to have your defibrillator monitored. With this you and your physician can receive advance warning if anything changed with the lead wires. It is not recommended to remove the lead wires if no problems have been experienced. The longer a patient has had the leads implanted, the more likely those lead wires will be surrounded by tissue, which makes them even more difficult to extract.
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