Two former users of the Sprint Fidelis cardiac leads from Medtronic, a Minneapolis- based medical device maker, filed a lawsuit yesterday for injuries sustained through the implantation of this device.
The suit was filed in the federal court in Minnesota and the plaintiffs, Leonard Stavish and Kelly Liusi, are suing for their own damages and as representatives of a class of all users of the device.
The plaintiffs 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 unnecessarily, or the device failed when it was supposed to provide defibrillation.
The suit alleges that Medtronic was aware of the fault in the Sprint Fidelis, but did not issue warnings that the lead wires were defectively designed. It is also alleged that the device violated consumer protection laws in the states where the plaintiffs reside.
Medtronic announced Monday that it was suspending all sales of its Sprint Fidelis line, and encouraged patients who had the device implanted to see their doctors. The specific model numbers are 6930, 6931, 6948 and 6949. Some 160,000 such devices have been implanted to date.