In January 2009 the United States District Court ruled the Sprint Fidelis Medtronic Lawsuit Dismissed. This ruling is currently under appeal and attorneys representing patients and families affected by the Medtronic lead recall continue to fight for their rights. The Medtronic recall involves only the Sprint Fidelis leads 6930, 6931, 6948, 6949 and not the implanted heart device.
Hundreds of thousands of people experience heart arrhythmia and require pacemakers to keep their heartbeat steady. The choices between different pacemakers are varied, but you can be certain that they will all have defibrillator lead wires that connect the pacemaker to the heart through the heart valves. These lead wires collect data from the heart and transfer it to the pacemaker, which will then release electric shocks to the heart to keep the heart’s rhythm steady.
Medtronic introduced revolutionary heart leads that had thinner lead wires, which made it easier to implant during the surgical process. Physicians were pleased with the ease with which these lead wires could be inserted, and therefore recommended them to many of their patients. The Food and Drug Administration approved these lead wires for use in 2004, and hundreds of thousands of patients use these Sprint Fidelis lead wires.
Complications with Sprint Fidelis Lead Wires
The thinner lead wires that made implantation easier on physicians are prone to tearing and fracture. When Sprint Fidelis Medtronic lead fracture occurs, the patient can receive unnecessary repeated electrical shocks to the heart, or they may receive no electric stimulus at all. Either condition can lead to serious heart arrhythmia that could result in heart attack and death. Research shows that there have been at least five deaths linked to the Sprint Fidelis leads. Medtronic, Inc., the manufacturer of the Sprint Fidelis pacemaker, estimates that up to 5,000 patients that received the pacemaker with faulty lead wires could experience tearing and fracture within the first thirty months after the implantation of the defibrillator. Patients that have a Sprint Fidelis pacemaker, but have not yet experienced any defects, could still suffer the complications at some point in the future.
Medtronics lawsuit
Many patients that have experienced the complications with Medtronic Sprint Fidelis lead wires are currently involved in a multi-district lawsuit against the medical device company, while hundreds of other patients are seeking legal representation daily. The Sprint Fidelis Medtronics lawsuit is centered in Minnesota, where the headquarters for Medtronic are located.
Claimants are seeking damages for lost wages, medical bills, and emotional distress. The lawsuit claims that the Medtronic Sprint Fidelis was released before adequate testing could be completed. Claimants also believe that the risks of using the Sprint Fidelis were not detailed in the marketing materials. An open letter was sent to doctors after the problems with the lead wires were discovered, but Medtronic continued to manufacture the defective lead wires and distribute them to new patients.
Next Steps for Patients with Sprint Fidelis Leads
It is not recommended to have any lead wires removed if you are not already experiencing problems with the lead wires. The lead wires that are implanted in the heart valves can become embedded in the tissue, which makes removal a very dangerous and complicated surgery. You can, however, have your physician recalibrate your device so that you can receive early warnings for any possible malfunction.