Two area residents have filed federal class-action lawsuits over malfunctions they said could occur in Medtronic Inc. heart defibrillators implanted in more than a quarter-million patients.

The lawsuits were filed against Minnesota-based Medtronic by Kenneth Carlile of Kansas City and Phillip S. Brown, a Johnson County resident.

The complainants contend that Medtronic was negligent in its design of electronic wires – known as SprintFidelis leads – that connect the defibrillators to patients’ hearts.

Medtronic in October voluntarily recalled the Sprint Fidelis wires because they can fracture, which causes them to give unnecessary shocks or not function at all. Medtronic said it had identified five patient deaths “in which a Sprint Fidelis lead may have been a possible or likely contributing factor.”

The Carlile lawsuit was filed in federal court in Kansas City and the Brown lawsuit was filed in federal court in Kansas City, Kan. Carlile received his implantation at the University of Kansas Hospital in November 2004, and Brown received his implantation at Menorah Medical Center in Overland Park in August. The hospitals are not defendants in the lawsuits.

Each lawsuit contains six counts, including allegations of negligence and failure to warn patients of problems with the Sprint Fidelis wires earlier.

Medtronic spokesman Rob Clark said the company did not comment on the specifics of litigation filed against it, adding that lawsuits could be expected when the company recalled products.

 



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