Medtronic Recall News
Patients are continuing to suffer from a Medtronic Sprint Fidelis lead fracture following the 2007 Medtronic recall of defibrillator leads. If you or a loved one has suffered from fractured leads please contact us today for a free consultation and information how we can help.
Medtronics Sprint Fidelis Recall for Heart Defibrillator Leads
If you are one of a quarter of a million people using a Medtronic defibrillator, you may be at risk for a malfunction in the defibrillator leads.
Medtronic’s defibrillator contains a type of wire with the brand name of Sprint Fidelis. These wires (also called leads) attach the defibrillator to the heart in order to monitor the heartbeat and to provide an electrical jolt as necessary to regulate the heart beat.
In some patients, the Sprint Fidelis wires have broken, or fractured. As a result, the defibrillator may send a massive electrical jolt to the heart. Conversely, it may not give a jolt of electricity when necessary.
The Sprint Fidelis lead was first used with an implantable cardioverter defibrillator (ICD) in 2004, with the advantage of the lead being thinner than its predecessor. However, that thinness may make the lead more susceptible to breakage.
In 2007, after the deaths of five patients using this device, Medtronic recalled this product. To date, a total of 13 patients have died in association with the use of Sprint Fidelis leads.
Nevertheless, in 2009, estimates are that 150,000 patients still have the leads implanted. It has been reported that lead failed in 5% of the devices after 45 months of use, which means at least 7,500 people may be at risk.
Unfortunately, there is no definitive way to determine which leads may fracture and which may not. In addition, the process of removing the leads is risky. After the defibrillator has been implanted, the leads may become covered with tissue, which makes them difficult to extract. Surgeons must be extremely careful not to puncture the heart or surrounding veins, which could cause excessive bleeding. At least four of the 13 deaths associated with Sprint Fidelis were due to lead extraction.
Medtronic, the largest maker of electronic heart devices, recommends that patients with a Sprint Fidelis defibrillator see their doctor to determine the best course of action, and suggests that in some cases, it may be safer to let the leads remain in place.
Medtronic has said it will pay for the cost of replacing defective leads, however this is only for patients whose defibrillator leads have actually fractured. Extraction surgery is a complicated and expensive procedure.
Experts recommend that anyone considering having the Spring Fidelis leads replaced find a hospital with solid experience in removal of the leads. Patients should look for medical facilities that have successfully completed at least 50 removals.
If you are a patient with a Sprint Fidelis lead, we encourage you to call us for the latest status of filing a Medtronic lawsuit.
We represent all Sprint Fidelis lead fracture clients on a contingency basis, which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free or fill out our short online contact form and a Medtronic recall attorney will contact you to answer any of your questions regarding the ongoing litigation.