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Recall of Defective Medtronic Sprint Fidelis Defibrillator Leads

Recall of Defective Medtronic Sprint Fidelis Defibrillator Leads

[Introduction: If you or a loved one has experienced an injury as a result of a lead fracture in a Medtronic Sprint Fidelis defibrillator lead, you may have a lawsuit that should be pursued. Although our Medtronic Sprint Fidelis defibrillator lead lawyers are located in Maryland (MD), Virginia (VA) and Washington, D.C. (DC), our medical product liability litigation is national in scope, and our Medtronic Sprint Fidelis defibrillator lead lawyers are prepared to file lawsuits and litigate Medtronic Sprint Fidelis defibrillator lead cases around the country. Therefore, regardless of what state you're from, please fill out our inquiry form on this web site or email us so that Ashcraft & Gerel, LLP can have a Medtronic Sprint Fidelis defibrillator lead lawyer contact you to discuss your claim and the potential of a lawsuit.]

Defibrillators are medical devices designed to monitor heart rhythms. They produce an electrical shock or rapid pacing to return the heart to normal rhythm when irregular heart beats are detected. These medical devices keep the heart from beating too fast. They are implanted in patients who are at risk of sudden cardiac arrest. 

On October 15, 2007, Medtronic, Inc., a manufacturer of defibrillators, voluntarily suspended worldwide sales and distribution of its Sprint Fidelis defibrillation leads because of the increased risk of lead fractures. Sprint Fidelis Leads are cardiac electrodes (thin wires) that connect the defibrillator to the heart. 

It has been reported that Medtronic knew about the defective leads prior to the October 15, 2007, recall. Medtronic began selling the Sprint Fidelis lead in 2004, which replaced an earlier, larger version, the Sprint Quattro, which was released in 2001. 

The fracture in the lead could cause the defibrillator to deliver an unnecessary and painful shock or jolt to the patient or to not operate at all. The Sprint Fidelis lead, implanted in a vein, connects the heart of a patient to the defibrillator, including the Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy - Defibrillators (CRT-Ds). The Medtronic Sprint Fidelis lead can also be used with defibrillators made by manufacturers other than Medtronic. 

Not included in the recall are Medtronic pacemakers. While defibrillators keep the heart from going too fast, pacemakers keep the heart from going too slowly. Also not included in the recall are Medtronic ICDs or CRT-Ds without a Sprint Fidelis lead.

The affected leads bear Model Numbers: 6930, 6931, 6948, & 6949. In connection with the recall, Medtronic noted that the failed lead wires caused by a fracture in a sensor conductor or coil caused and/or contributed to the death of at least 5 patients. Medtronic estimates that about 5,000 people will experience a lead fracture within 30 months of having the Sprint Fidelis implanted. Thousands of patients are at risk for failure and there is no test to predict which leads will fail. It is estimated that over 280,000 patients worldwide who have received a defibrillator since 2004 are left with the option of leaving the defective device in their bodies or proceed with potential life- threatening, high risk, replacement surgery of the defective lead.

Although the FDA considers Medtronic's action a recall of the Sprint Fidelis lead, the FDA is not recommending removal of the recalled leads given the heightened risk of the surgery. The FDA states: "A recall is an action taken when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A recall for an implantable medical device does not always mean that the device has to be removed." The FDA recommends that doctors weigh the risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.

However, younger patients are at a greater risk of experiencing a lead fracture. According to a report in the Wall Street Journal, the leads that attach to the defibrillator tend to "come under greater stress in more active people, including children, adolescents and younger adults" because the heart beats faster in younger adults and children.

If you would like to identify whether or not you have a Sprint Fidelis lead, you may have been given a card that identifies the devices implanted in you. If you have any uncertainty about your devices, you should contact your physician.

If you or a loved one has has been injured by a defective Medtronic Sprint Fidelis defibrillator lead, you owe it to yourself to speak to an experienced pharmaceutical and medical product liability attorney to see if you have a case and to discuss the possibility of bringing a lawsuit to recover for your damages and injuries. The attorney will be able to ascertain if you have a claim for which a lawsuit can be pursued and whether the case and lawsuit can be brought to a successful settlement, verdict, award or other recovery. The experienced lawyer will also be able to advise you on any deadlines for bringing your legal claim for damages. Please contact the law firm of Ashcraft and Gerel, LLP to discuss your lawsuit with an experienced medical product liability lawyer in our Drug and Medical Product Liability Litigation Department. 

The law of most states provides several grounds for lawyers to bring personal injury claims for persons who have been seriously injured by a defective medical device. The lawyer bringing such a case may include in his theory of recovery legal doctrines imposing strict liability for a defective product, breach of warranty, and negligence. For persons who have died, the attorney representing their surviving spouse or other family members can bring a wrongful death law suit. Ashcraft & Gerel's attorneys are now reviewing Medtronic Sprint Fidelis defibrillator lead claims. Our attorneys have been leaders in mass tort and medical product liability cases and settlements, including asbestos, breast implants and tainted blood. Our lawyers have been at the forefront of the Fen Phen diet drug claims. Although some of these claims and lawsuits resulted in class action settlements, a class action is not the only way these cases can be handled. The courts have devised methods to deal with mass torts so that each lawsuit can benefit from information and evidence gathered in other lawsuits nationwide and yet be handled on an individual basis. 

We have a toll free number for an attorney to answer your questions with regard to your specific claim. That number is 1-800-725-6470. If you would prefer that one of our lawyers contact you, please feel free to email us or complete the help inquiry form on this web site, and a lawyer will respond to your case inquiry within 24 hours.