Defective Lead Wires in Implantable Defibrillators have been Linked to Five Deaths and Hundreds of Injuries
In October 2007, the medical technology company Medtronic voluntarily suspended distribution of its Sprint Fidelis leads. The thin lead wires are a vital part of implantable defibrillators, a lifesaving device that helps regulate patients’ heart rhythms. But a defect in the leads has been linked to at least five deaths and hundreds of injuries.
Even worse, the manufacturer apparently knew about the problem for months before it stopped selling the defective product.
If you are one of the 268,000 patients who may have defective Sprint Fidelis leads, contact your doctor immediately to discuss your medical options.
The MEDLaw Legal Team of Janet, Jenner & Suggs is representing patients and families who have been harmed by the malfunctioning Sprint Fidelis leads. We encourage you to contact our lawyers today for an immediate free claim evaluation. Call 1-888-4-MEDLAW or complete our online claim evaluation form.
The Fidelis lead is a thin wire that runs from the defibrillator to the heart. It allows the defibrillator to monitor the patient’s heartbeat and deliver a lifesaving electrical shock if necessary.
If a fracture or break occurs in the lead, the signal is interrupted. The fractured lead can cause the defibrillator device to release an unneeded and painful shock. The fracture can also drain the defibrillator’s battery and keep it from delivering a shock during a cardiac event. That means at the very moment when the patient’s life depends on the reliability of the leads, the device may malfunction.
The Fidelis leads were introduced into the marketplace in September 2004. By early 2007, about 90 percent of new Medtronic defibrillators used Fidelis leads. However, by January of that year, Medtronic had received 679 reports of injuries caused by fractures in the Fidelis leads.
Medtronic initially attributed the failures to surgical error or variables during the implant procedure, but it soon became apparent that the problem was with the product itself. By June 30, 2007, the number of lead failures resulting in an injury had grown to 1,053. That prompted the company to halt distribution of the product in October 2007.
The Sprint Fidelis lead has been implanted in an estimated 268,000 patients. The lead was used for other defibrillators besides the Medtronic brand, including defibrillators made by Guidant and St. Jude.
Based on information regarding the 268,000 implanted Sprint Fidelis leads, Medtronic said it had identified five patient deaths in which a lead fracture may have been a possible or likely contributing factor. By the company’s own estimates, 2.3% of the patients with Sprint Fidelis leads -- or about 4,000 to 5,000 patients -- will likely experience fractures in the leads.
The Food and Drug Administration has urged anyone with a Sprint Fidelis lead to visit their doctor immediately, especially if they experience palpitations, multiple shocks, fainting or lightheadedness.
Medtronic stated that that the risk of complications was higher for removing defibrillators with the leads than leaving them in place. The company advised patients to have the defibrillators removed only if the Sprint Fidelis leads fractured.
The company also advised patients with Sprint Fidelis leads to see their doctor and have their defibrillators reprogrammed to better monitor any problems.
The MEDLaw Legal Team of Janet, Jenner & Suggs is a nationally recognized law firm dedicated to representing victims of negligently manufactured medical devices like the Sprint Fidelis leads. Our team of seasoned litigators includes physician / attorneys and nurse / attorneys. As reported in national media such as USA Today, Jet Magazine, the Washington Post, and Dateline NBC,
our lawyers have won substantial legal compensation for patients and victims in nationwide lawsuits.
We encourage you to contact our lawyers today. Call 1-888-4-MEDLAW or complete our online claim evaluation form.
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