Medtronics Defibrillator Recall
Sprint Fidelis® Leads
Extent of the Problem: On October 15, 2007, Medtronic, a medical device manufacturer, ceased the production and sale of four Sprint Fidelis® implantable cardioverter defibrillator (ICD) leads (model numbers 6930, 6931, 6948 and 6949) in the United States and abroad due to technical problems. These problems include fractures of the leads, which can cause inappropriate electrical shocks and even death. To date, the leads have been implanted in 172,000 patients in the U.S. and 96,000 patients in foreign countries and have caused 5 reported deaths. More problems of a nonfatal nature have been reported in the medical literature as outlined below.
1) What does an implantable cardioverter defibrillator (ICD) do and how does it work? An ICD is a device placed under the skin primarily by a cardiologist who specializes in disorders of the electrical rhythm of the heart, or cardiac arrhythmias. It is used in those patients who develop life threatening ventricular fibrillation or ventricular tachycardia (fast heart rate). ICDs consist of 2 parts:
(a) Leads or thin wires that sense the cardiac rhythm and deliver electrical shocks as needed, often through overdrive pacing. These leads are attached to
(b) A pulse generator which is the palpable box implanted under the skin of the upper left chest in most patients. When the ICD detects life threatening ventricular fibrillation or pulseless ventricular tachycardia, the defibrillator shocks the heart back into a normal heart rhythm.
2) Why are Sprint Fidelis® leads being recalled? Five people have died due to fractures of Sprint Fidelis® leads, leading to unnecessary electrical discharges or defective sensing and capturing of electrical cardiac impulses. This problem is under current investigation by the FDA and appears to be more common than previously appreciated. As a result, Medtronic has undertaken a voluntary recall of these Sprint Fidelis® leads to limit the potential for further harm to patients.
This problem first came to light in the spring of 2007, when the Minneapolis Heart Institute determined that 6 out of 583 patients between 2004-07 had experienced fracture of Sprint Fidelis® lead 6949. This failure rate of over 1% is a ten-fold increase compared to historical controls using a different lead system. This observation has been borne out by investigators at Cornell University Medical Center. The most likely reason that the leads fracture is the small diameter of the coil and conductor within them leading to trauma or kinking during and after insertion. Internal Medtronic documents reveal over 1000 complaints regarding the Sprint Fidelis® lead system and most relate to lead fracture and inappropriate shocks. Medtronic first responded simply by sending out a "Dear Doctor Letter" to cardiologists and cardiac surgeons, advising them of a higher incidence of conductor fracture rates in Sprint Fidelis® leads but on October 15, 2007, Medtronic initiated a recall of all unimplanted Sprint Fidelis® leads and recommended close monitoring of all leads already implanted.
3) Who is Medtronic, Inc? Medtronic is a global medical product manufacturer which generates over $12 billion in annual revenue. They are the largest seller of heart devices such as defibrillators and pacemakers. Their products account for over half of the $6 billion defibrillator market.
4) What are Sprint Fidelis® leads? Leads are thin wires that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life threatening heart rhythms occur.
5) What is a medical device recall? 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.
6) Why are Sprint Fidelis® leads being recalled? According to Medtronic's own estimate, appoximately 4,000 to 5,000 people with a Sprint Fidelis® lead will experience fracture within 30 months of having a defibrillator implanted. If the lead wire fractures, three things can happen. The implanted defibrillator will beep, alerting the patient to seek immediate medical care. Or, the fracture can create a massive electric shock that causes the patient extreme and sudden chest pain. But most disturbingly, the fracture of a Sprint Fidelis® lead can deplete the defibrillator's battery. If this happens, the defibrillator can fail to deliver the necessary, life-saving shock.
7) How many people have had the Sprint Fidelis® lead implanted? As of October 4, 2007 there have been approximately 268,000 Sprint Fidelis® leads implanted worldwide, including 172,000 in the United States. The Sprint Fidelis® lead may have been used to connect devices manufactured by other companies such as Guidant and Boston Scientific, as well as, Medtronic's own devices.
8) How do I know if I have a Sprint Fidelis® lead? If you have been advised that your lead must be replaced, check your device identification card to determine if it is a Medtronic Sprint Fidelis® lead. If so, please contact our office, at no charge, to discuss your situation.
9) What should I do if I have a Sprint Fidelis® lead implanted? Patients who have had the Sprint Fidelis® lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Despite the risk of Sprint Fidelis® lead problems, experts are recommending that the wires not be removed. 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.
10) How big is the problem? As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis® leads implanted worldwide, including 172,000 Sprint Fidelis® leads implanted in the United States. According to Medtronic's own estimate, approximately 4,000 to 5,000 people with a Sprint Fidelis® lead will experience fracture within 30 months of having the defibrillator implanted. Those patients whose Sprint Fidelis® lead fractures will require a dangerous surgical procedure to have the wire replaced.