On November 28, 2007, a second lawsuit was filed against the manufacturer of the recalled Spring Fidelis lead, Medtronic Inc.

On August 12, 2007, in Bowling Green, Kentucky, Kim Orange’s defibrillator failed and caused her to receive three electrical shocks. Orange was transported from Bowling Green to Vanderbilt University Medical Center in Nashville, Tennessee, by ambulance. She suffered two more shocks the same day.

Orange alleges the shocks from a defective Spring Fidelis lead connecting her defibrillator to her heart forced her to undergo complicated surgery to remove the faulty device and implant a new lead system. Orange contends surgery further damaged her heart.

Approximately 235,000 people are potentially affected by Medtronic’s recall of the Spring Fidelis lead wires on October 15, 2007. The recall came following five reports of death in which the Spring Fidelis lead fracture was a contributing factor. Orange’s complaint claims a design defect in the small diameter of coil and conductors used in the leads attributed to Orange’s lead failures. The combination of design defect and stress damage occurring during and after the implantation can cause the conductors to become overstressed, thus creating a fracture in the wires.

“You fear that you have a ticking time bomb inside your body that could unexpectedly explode or be triggered by a quick movement or vibration,” Ms. Orange said. “Exertion such as bending over to make a bed, mowing the lawn and other everyday tasks have become frightening experiences.”

Orange’s lawsuit was filed in Minnesota, where Medtronic Inc is based. The lawsuit seeks damages for physical pain, medical expenses, and compensation for Orange’s future medical care and expenses.

Source: “Kentucky Resident Files Lawsuit against Medtronic for Faulty Defibrillator Lead Wire That Caused Devastating Electrical Shocks,” Newswire, November 28, 2007.