The leads were implanted into hundreds of thousands of patients who are now at risk of serious injury if their Sprint Fidelis Lead malfunctions. All unused leads were recalled by Medtronic on October 15, although Medtronic is actually referring to the recall as a "voluntary market suspension." Leads that have been suspended contain the model numbers 6930, 6931, 6948 and 6949 either by themselves or at the beginning of a longer model number. Patients who have defibrillators manufactured by Guidant and St. Jude may also have the Medtronic Sprint Fidelis Lead implanted in them and should consult their physicians to discuss their options.
Sprint Fidelis Leads that have already been implanted are not being removed because surgery to remove a fractured lead wire is risky and can cause tearing or scarring of the heart tissue and veins that house the lead. There is currently no test to predict whether or not a lead will fracture and malfunction, meaning that patients have no way of knowing whether their lead could stop working in the future.
Lawsuits have been filed against Medtronic alleging the company is responsible for causing injury to defibrillator patients. A class action lawsuit was filed on October 15 in Minnesota, seeking compensatory, injunctive, equitable and declaratory relief. The plaintiffs claim that Medtronic misrepresented and concealed the safety and possible defects of its Sprint Fidelis Leads in order to protect profits. The suit also seeks relief for unjust enrichment and medical monitoring.
According to a letter from Dr. Sidney M. Wolfe of Public Citizen to the US Food and Drug Administration (FDA), more than 1,600 injury reports were filed over the past two years, with more than 750 reports listing "inappropriate shocks" as being received by the patient. One of the patients in the Minnesota lawsuit alleges he received 47 unnecessary shocks from his defibrillator because of the faulty wires, resulting in surgery to remove the defective lead.
The letter also notes that the Minneapolis Heart Institute contacted Medtronic in February 2007 about problems related to malfunctioning leads. An article by researchers at the Minneapolis Heart Institute compared lead failures in Medtronic's Sprint Fidelis and Sprint Quattro models. The study found that the Sprint Fidelis Lead had a higher risk of fracturing than the Sprint Quattro. In fact the Heart Institute was so concerned about defective lead wires that it stopped implanting them in January 2007.
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There is some concern that young adults and children are at a greater risk of lead fracture because the Sprint Fidelis leads are a smaller diameter than other products and were used frequently in younger patients. Patients who are more active may put additional stress on the Fidelis leads.
If you are concerned that you have been implanted with a Sprint Fidelis Lead, check your patient card that identifies which implanted devices you have. If you do not have a patient card, or are still uncertain as to what devices were used, contact your doctor for more information.