The Sprint Fidelis® Defibrillator Lead is subject to a Class 1 recall by the FDA. Class 1 recalls are the most serious type of recalls and involve situations in which there is a reasonable probability that use of product will cause serious injury or death.
Medtronic, Inc. (Medtronic), on October 15, 2007, announced that it would stop selling and recall all Sprint Fidelis® Defibrillator Leads not yet implanted. The FDA classified this recall as a Class 1 recall. Class 1 recalls are the most serious type of recalls and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. Medtronic and the FDA have urged patients implanted with this device, to immediately contact their physicians, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.
What Is A Sprint Fidelis Lead and Why Is It Used?
Manufactured by Medtronic, Inc., Sprint Fidelis® Leads are specific models of cardiac electrodes (thin wires) that connect to an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. This connection allows ICDs and CRT-Ds to monitor heart rhythms and deliver electric shocks or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected.
The Sprint Fidelis® Leads were first introduced by Medtronic in 2004, and have been used with most implantable defibrillators since then. The wires in these leads are thinner than Medtronic’s older Sprint Quattro® Leads, which were introduced in 2001. Medtronic believed the thinner wire would make the leads easier to install. To date, Sprint Fidelis® Leads have been implanted in over quarter million patients.
What Is the Danger With Sprint Fidelis Leads?
Medtronic provided the basis of the recall on October 15, 2007 when it announced that Sprint Fidelis Leads® are prone to fracturing within patients’ blood vessels, causing defibrillators to misread heart rhythms. This can cause defibrillators to either deliver unnecessary shocks or fail to deliver life-sustaining shocks when necessary.
According to Medtronic’s own estimate, approximately 2.3%, or 4,000 to 5,000 people with Sprint Fidelis® leads will experience lead fracture within 30 months of having a defibrillator implanted. At least five patient deaths have been attributed to defective Sprint Fidelis® leads.
The Wall Street Journal reported, on October 19, 2007, that the recalled Sprint Fidelis® Leads may pose an even higher risk of fracture in younger adults and children, a group for whom the devices were often used because of their smaller diameter. “Preliminary data from physicians at 32 institutions who specialize in treating pediatric patients and adults with congenital heart disease showed a fracture rate of 6.7% among 569 patients with Sprint Fidelis® leads over 30 months.”
Those patients whose Sprint Fidelis® leads fracture may have to undergo invasive surgical procedure to have the leads replaced or capped. Regarding this procedure, George Van Hare, a professor at Stanford Medical School, states, “To remove one of these things is not just difficult, but can be dangerous.” The procedure can lead to what some doctors estimate as a 1% possibility of a tear in the vein or the heart itself, and the possibility of dangerous or lethal bleeding. In 2004, a Dutch study found that major complications occurred in six out of 82 lead-extraction cases, including two patients who died. We urge you to discuss the risks and benefits of this procedure with your physician.
The Sprint Fidelis Defect
Medtronic has not disclosed the precise mechanism of the Sprint Fidelis® Lead fracture failures. But there is growing speculation that the thin design of Sprint Fidelis® Leads might not be durable enough to survive either the pressure of implantation or the stresses exerted on them once they are in the body. At least one top medical officer at Medtronic has defined the lead fractures as “classic fatigue failures,” a term that typically describes a weakening of metal exposed to repeated stress.
Medtronic Knew of Risk of Fracture Yet Failed To Warn Consumers
Medtronic was aware of the defective nature of the Sprint Fidelis® Leads long before the recall was issued.
Dr. Robert G. Hauser, a senior cardiologist at the Minneapolis Heart Institute published an analysis in early 2007 that found, among other things, a significant number of patients were experiencing “inappropriate” shocks because their defibrillators were firing when not needed. Dr. Hauser discussed his findings with Medtronic officials in 2007, but Medtronic did not suspend sales of the leads until October 2007.
Further, hundreds of injuries linked to Sprint Fidelis® Leads were reported to the Food and Drug Administration last year. The FDA had received 599 reports of malfunctions and injuries associated with the Fidelis leads as of January 10, 2007, including 204 where patients had been inappropriately shocked.
Despite being aware of the early and high failure rate of the Sprint Fidelis® Leads, as mentioned above, Medtronic failed to issue a recall and instead continued to sell the devices.
On October 18, 2007, it was reported that U.S. Senator Charles Grassley has called on officials at Medtronic and the Food and Drug Administration (FDA) to explain why “Medtronic took months to stop the sales of the faulty lead, even though the problem had been reported in a peer-reviewed journal months prior.”
How Lopez McHugh, LLP Can Help
The attorneys of Lopez McHugh LLP have earned a national reputation in litigation involving defective drugs and medical devices, including leadership roles in cases such as fen-phen, Baycol®, Rezulin®, Zyprexa®, Propulsid®, Ephedra, Vioxx®, Sulzer Hip and Knee implants, Guidant and Medtronic defibrillators and the Ortho Evra® birth control patch.
Currently, Lopez McHugh is at the forefront of the litigation now developing around the country against the manufacturers of these defibrillator leads. We are cooperating with other consumer advocate firms; we are consulting with medical experts, conducting extensive investigation, monitoring hearings and developments at the FDA and planning our litigation strategy against these medical device giants.
If you have been implanted with a Sprint Fidelis® Lead you may qualify to seek compensation for your losses. Please contact us today for a FREE case evaluation with an experienced product liability attorney who can inform you of your legal rights and ensure you get the compensation you deserve for your injuries and suffering.