In January 2004, Medtronic Inc. announced the first implant of the Sprint Fidelis defibrillation lead family by Dr. Raymond Yee at the London Health Sciences Center in London, Ontario, Canada, on a 51-year-old man with a primary indication for an implantable cardioverter-defibrillator (ICD) for ventricular fibrillation. With only 6.6 French in body diameter, the Sprint Fidelis lead was the smallest in the industry, allowing insertion with a 7-French introducer. Marketers proclaimed that the lead’s small body was designed to minimize venous obstruction and reduce tissue growth around the defibrillation coils.
The Sprint Fidelis lead was first marketed in the US on September 2, 2004. Ironically, promotional materials indicated that the slim body facilitated lead removal in the rare cases when that is necessary. As it turns out, more than a few patients are requiring extraction or the placement of additional leads due to fractures at conductor sites.
Many pediatric cardiac electrophysiologists have used the Sprint Fidelis leads in children and young adults because of their small diameter.
Leads included in Medtronic’s October 15, 2007 recall include model numbers 6930, 6931, 6948, and 6949 manufactured from September 2004 through October 15, 2007. Patients are generally given implant cards which contain the model and serial numbers of their generators and leads. The recall includes only Sprint Fidelis leads – not implantable cardioverter-defibrillators (ICDs), cardiac resynchroniation therapy defibrillators (CRT-Ds) or pacemakers. Leads comprise cardiac electrodes (thin wires) that connect heart devices directly to the heart. Sprint Fidelis leads were used in conjunction with ICDs and CRT-Ds – not pacemakers.
Patients who are implanted with this lead or who do not know the model of their lead should contact their physicians for further information. Medtronic has advised doctors to stop using these leads and to return unused products to the company.
The devices are being recalled because of the potential for lead fractures. These electronic wires are prone to fracture, causing the defibrillator to deliver unnecessary and massive shocks, emit a beeping sound, or to not operate at all.
In a Consumer Updated dated October 15, 2007, the US FDA advises patients with the Sprint Fidelis lead to contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.
FDA cautions that patients should not routinely seek removal of the device in that the risks of removal in most patients exceed the small risk of lead fractures: “it is generally recommended to leave functioning leads in place. There are two alternatives to removing the lead. One is to continue using the lead while monitoring closely for signs of fracture. A second is to surgically add a replacement lead. Adding a replacement lead does not require removing the Sprint Fidelis lead. If the Sprint Fidelis is left in a patient without being used, it must be “capped”, which means covering the tip with a small plastic insulation.”
Doctors disagree as to whether lead extraction or adding a new lead threaded through the same vein is better. Many patients will have to have the lead removed if their vein will not accommodate a new lead. Medtronic states that it will pay for a new lead and up to $800 for unreimbursed medical expenses if a Sprint Fidelis lead is fractured.
Should patients require removal of their Sprint Fidelis lead, they are advised to seek a physician with extensive lead extraction experience. It has been reported that limited physician experience (less than 50 procedures) may significantly increase the risk of complications from extraction.
FDA adds that Medtronic provided guidance to physicians on how to reduce the risks in affected patients and ensure that devices are set to more effectively monitor for potential fractures. These recommendations include specific programming instructions and review of the lead’s performance trends, but not more frequent follow-up. Reprogramming may detect whether the wire is tearing, minimize or eliminate inappropriate shocks, and cause a beeping sound to emit from the device if there’s a problem.
Some doctors are also recommending that patients sign up for Medtronic’s monitoring system, known as CareLink, which could alert patients that a lead is beginning to fracture.
On October 15, 2007 Medtronic Inc. initiated a Class I recall of Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
Sprint Fidelis leads were manufactured in a Medtronic facility in Puerto Rico, while the company’s headquarters are located in Minneapolis, Minnesota. Medtronic’s Cardiac Rhythm Disease Management segment offers implantable devices, leads, ablation products, electrophysiology catheters, and information systems for cardiac rhythm diseases. Company sales over the past 12 months total 12.53 billion.
Sprint Fidelis Lawsuit From Defibrillator Leads Recall No Surprise
News of the recall came as no surprise to physicians as many had already stopped using Sprint Fidelis leads. Dr. Robert Hauser, of the Minneapolis Heart Institute, had discontinued using Sprint Fidelis leads in January 2007 and contacted Medtronic in early February about the device problems. Dr. Hauser published a review of injury cases in the April 13, 2007 issue of Heart Rhythm.
Dr. Hauser reported that Sprint Fidelis 6949 leads implanted at the Minneapolis Heart Institute were significantly less reliable than Medtronic’s Sprint Quattro Secure 6947. Six of 583 patients presented with Sprint Fidelis lead failure from four to 23 months after implant. Five of the six patients experienced multiple inappropriate shocks; the sixth patient had a fixation mechanism failure. None of the six device failures resulted in a serious injury, and all were replaced without incident. Medtronic admits that inappropriate shocks are frightening and uncomfortable, but adds that they are not life threatening. However, Dr. Hauser reports that he learned of a young man in London who died after “inappropriate shocks” altered his heart rhythm.
On March 21, 2007 Medtronic sent a letter to physicians about the problems leads on the advice of an independent panel of doctors. Medtronic described two lead locations where chronic conductor fractures have occurred: 1.) the distal portion of the lead, affecting the anode (ring electrode); and 2.) near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor. Anode or cathode conductor fractures at either location may cause increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output. High voltage conductor fractures could result in the inability to deliver defibrillation therapy.
Dr. Hauser and his colleagues analyzed FDA’s adverse event database, MAUDE, and found reports for 679 Sprint Fidelis leads. The most frequent complaints or observations were inappropriate shocks (33%); high impedance (33%); and fracture (35%). Then, of 125 leads evaluated by Medtronic, 62 involved fracture of the pace-sense conductor or coil and high-voltage (defibrillation) conductor.
Dr. Hauser and his colleagues concluded that use of the Sprint Fidelis leads should be limited until the failure mechanism is identified and corrected. Dr. Hauser speculated that the thinner lead was weaker.
In July 2007, an article published in the Minneapolis-St. Paul Star Tribune revealed that most key cardiologist in that area had stopped using Sprint Fidelis.
Medtronic reported that, as of October 4, 2007, there were approximately 268,000 Sprint Fidelis leads implanted worldwide, including 172,000 in the United States. Of the 268,000, about 235,000 patients still have the leads. Medtronic revealed that lead fractures may have been a possible or likely contributing factor in five patient deaths. Of 665 confirmed chronic fractures in returned leads, approximately 90% of the fractures occurred in the anode or cathode conductors, while 10% occurred in the high voltage conductors.
Finally, on October 15, 2007 Medtronic sent letters to more than 13,000 doctors worldwide, as well as to patients with the device. Medtronic explained that it based its decision on a variety of factors, including extensive performance data which shows that Sprint Fidelis lead reliability was less than that of Sprint Quattro at 30 months, 97.7% vs. 99.1%, respectively. Medtronic stated: “This difference is not statistically significant; however, if the current lead fracture rates remain constant, it will become so over time. Medtronic believes that given this performance trend and its ability to identify the primary fracture locations, this action is in patients’ best interest.”
In his October 16, 2007 letter to FDA Commissioner Andrew von Eschenbach, MD, Commissioner, Sidney M. Wolfe, M.D., Director of Public Citizen’s Health Research Group, an independent, nonprofit consumer-advocacy organization, called for an investigation of the Sprint Fidelis recall. Dr. Wolfe wrote: “Medtronic and the FDA already were aware of an escalating number of reports of injury in patients with this Fidelis lead. By Jan. 10, the cumulative number of injury reports associated with this lead reported to the FDA database was 599, including 204 cases in which patients got inappropriate electric shocks from their defective defibrillators. Despite this strong warning signal about these defective components, in the same month, January, Medtronic launched a massive direct-to-consumer advertising campaign to lure patients to seek advice from their doctors as to whether they could benefit from having a defibrillator implanted.”
Dr. Wolfe suggests that Medtronic may not have considered the problem’s significance or the interests of those patients’ with defibrillators implanted after January 10, 2007 since “it is likely that the 1,030 injuries reported to the FDA after Jan. 10 included many patients with defibrillators implanted after this date. Had the recall and further implantations stopped then – instead of nine months later (this week) – many patients would have been spared the injuries and anxiety that occurred with these recent implantations.”
Sprint Fidelis leads may pose a higher risk of fracture in children, adolescents and younger adults because they come under greater stress in more-active people. Medtronic reported that of the 268,000 Sprint leads implanted, 2,085 were in patients under the age of 21.
According to the Wall Street Journal, “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. The “vast majority” of the patients are likely to be under the age of 21, given the physicians involved, says Wayne H. Franklin, an associate professor at Northwestern University’s Feinberg School of Medicine, who gathered the physician reports.
“Medtronic has reported a lower failure rate, 2.3% after 30 months, for all patients implanted with one particular Sprint Fidelis model. For that same model, Dr. Franklin saw a fracture rate of 4.9% among 304 patients in his survey. The real difference may be slightly greater, because the failure rate from Medtronic includes more than just fractures.”
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