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
LOUISVILLE, Ky. (PRWEB) November 28, 2007
On August 12, 2007, the Sprint Fidelis lead, the wiring that connected her defibrillator to her heart, failed, causing three devastating electrical 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, 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."
Information for Heart Patients
On October 15, 2007, due to reports of adverse events and at least five patient deaths with defibrillator leads sold under the brand name Sprint Fidelis, Medtronic issued a recall of the product.
Leads are the thin insulated wires connected to a defibrillator that carry electric impulses to the heart. Your wallet card will specify the manufacturer of your defibrillator leads
If you would like to learn more about the Medtronic recall and your legal rights, please visit http://www.medtronicheartleadrecall.com/
Patients that have had to undergo surgery to replace a faulty lead or have been advised by a physician their lead may be defective are also welcome to call counsel toll free at 1-800-541-7358 and ask to speak to attorney Heather A. Foster of Lieff Cabraser Heimann & Bernstein, LLP.
Resources for Reporters
Reporters that wish to receive a copy of the complaint are welcome to contact Brandan de Coteau of Lieff Cabraser at email@example.com or (415) 956-1000.