COURT CASES: "Kentucky Resident Files Lawsuit Against Medtronic For Faulty Defibrillator Lead Wire That Caused Devastating Electrical Shocks"
Kim Orange of Bowling Green, Kentucky, today filed a personal injury lawsuit against Medtronic Inc., for suffering devastating electrical shocks due to a defective lead wire system for her defibrillator. The lawsuit, filed in Minnesota state court where Medtronic is based, seeks damages for the physical pain and medical expenses Ms. Orange has incurred, as well as compensation for Ms. Orange future medical care and expenses due to the defective Medtronic device.
LOUISVILLE, Ky. (Business Wire EON) November 28, 2007 -- On August 12, 2007, the Sprint Fidelis lead, the wiring that connected her defibrillator to her heart, failed, causing three devastating lectrical shocks. Ms. Orange was transported by ambulance from Bowling Green to Vanderbilt University Medical Center in Nashville, Tennessee, suffering two additional shocks the same day. The failure of the Sprint Fidelis lead forced Ms. Orange to undergo complicated surgery on August 15, 2007, to remove the faulty device and implant a new lead system.
The early explant and implant of a new lead system, as well as a new defibrillator, scarred her already fragile heart. "I felt like I was being repeatedly shot or kicked in the chest by a horse," Ms. Orange stated. "The pain was intense and has the power to knock you down or out of a chair."
Ms. Orange's life has been substantially affected by the incident. Ms. Orange's physician instructed her to take off work. "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 explained. "Exertion such as bending over to make a bed, mowing the lawn and other everyday tasks have become frightening experiences."
Medtronic has not disclosed the precise mechanism of the Sprint Fidelis lead fracture failures. The complaint charges that a design defect was responsible for the failure of Ms. Orange's lead. It appears the defect is attributable to the small diameter of the coil and conductors used in the leads. Because of this, the leads are subject to stress damage both during and after the implant. Fracture eventually occurs when the conductors are critically overstressed.
"Manufacturers of medical devices have a duty to patients to produce safe products," stated H. Philip Grossman, of Louisville, Kentucky law firm of Grossman & Moore, counsel for Ms. Orange. "Medtronic failed to comply with this duty with regard to the recalled lead wires. The Medtronic Sprint Fidelis lead has a significantly higher than expected failure rate that appears in just the first two years after implantation."
"The defect is potentially fatal. Yet, Medtronic has not agreed to compensate patients for their extreme injuries and having to undergo invasive surgeries to replace the fractured leads," noted Mark P. Chalos of the Nashville office of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP, which is also representing Ms. Orange. "Only by filing a lawsuit or otherwise making a claim against Medtronic can injured patients obtain justice and compensation for their injuries."
