On Monday, Medtronic voluntarily suspended worldwide distribution of its Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis models: 6930, 6931, 6948 and 6949). In response, two former users of the Sprint Fidelis cardiac leads initiated a lawsuit for injuries sustained through the implantation of this device.
The Sprint Fidelis leads are used to deliver therapy in defibrillators, including implantable cardioverter defibrillators and cardiac resynchronization therapy–defibrillators. Approximately 268,000 Sprint Fidelis leads have been implanted worldwide. The Minneapolis-based Medtronic said the current decision does not affect its pacemaker patients.
According to a Medtronic release, the decision to suspend distribution of the leads is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Based on Medtronic’s extensive performance data, its Sprint Fidelis lead viability is trending lower than Medtronic’s Sprint Quattro defibrillation lead at 30 months (97.7 percent Sprint Fidelis vs. 99.1 percent Sprint Quattro). Medtronic believes that given the performance trend and its ability to identify the primary fracture locations, this action is in patients’ best interest, according to the company.
“Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety,” according to Daniel Schultz, MC, FDA director of the Center for Devices and Radiological Health.
Schultz also said that the electronic wires used in defibrillators “are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.”
The lawsuit was filed in the federal court in Minnesota, and the plaintiffs are suing for their own damages and as representatives of a class of all users of the device.
The plaintiffs, Leonard Stavish and Kelly Liusi, allege that the lead wire portion of the defibrillator was defective, due to cracks that develop in the wire. As a result, users of the device either received jolting shocks when it falsely detected, or that the device failed, so that when they actually needed defibrillation they could not get it.
The suits allege that Medtronic was aware of the fault in the Sprint Fidelis, but did not issue warnings that the lead was defectively designed. It is also alleged that the device violated consumer protection laws in the states where the plaintiffs reside.
Based on current information regarding the 268,000 implanted leads, Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.