On October 15, 2007, the Medtronic Corporation announced the voluntary recall of all models of Medtronic Sprint Fidelis Defibrillator Leads. This recall consists of all serial numbers with the model numbers: 6949, 6948, 6931, and 6930.
In general, a lead is a wire that is attached to an implantable defibrillator and is connected to a patient’s artery. When the defibrillator detects that a patient needs to receive a shock, the defibrillator issues a charge which travels through the lead and shocks the artery thus pacing the heart correctly. Every heart defibrillator that is implanted in a patient has at least one lead. Medtronic has recalled these certain types of leads because the outer coating on these leads has been known to crack and therefore these leads have been malfunctioning. If a Medtronic lead has cracked and is not functioning, the defibrillator is rendered useless because it cannot deliver the proper charge to the artery. Failure of the defibrillator lead at a time needed may result in death. In addition, failed leads have delivered unnecessary shocks to patients. It is estimated that there are approximately 268,000 recalled leads that have already been implanted in patients.
Every individual who had a heart defibrillator implanted at one point was given a device identification card that will indicate the model and serial number of the defibrillator that was implanted as well as the model and serial number of each lead that was also implanted. Usually, the top model and serial number on the identification card represents the actual type of defibrillator implanted and the bottom two numbers represent the type of each lead that was implanted. When identifying if one of these leads has been recalled, only look at the first four (4) digits of the model number to see if they match those model numbers that were previously listed as recalls. The first four (4) numbers on the identification card gives the model number of the lead and the last two (2) digits represent the length of that lead.
FDA Statement on Medtronic’s Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads
Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health:
Medtronic’s decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.
These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.
Defibrillators are life-saving products for patients with a heart rhythm abnormality. We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect. However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.
Today, Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.
Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today’s action.
Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.
When a defibrillator lead is slightly more prone to fracture, it doesn’t mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or “fractures,” the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don’t know if this rate of adverse events will remain constant or increase over the life of these leads.
FDA considers Medtronic’s action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. We recognize that some patients and health care professionals might inappropriately interpret the word “recall” to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.
The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic’s recommendation that defibrillator settings be adjusted at the patient’s next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed.
Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and 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.
Patients should recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.
FDA will continue to monitor information on these devices and will take whatever other actions may be necessary.
Questions and Answers for Consumers
What are Sprint Fidelis Leads?
Manufactured by Medtronic, Inc., Sprint Fidelis Leads are specific models of cardiac electrodes (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.
How do defibrillators work?
Defibrillators monitor heart rhythms. They deliver an electrical shock or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected. These devices keep the heart from going too fast. They are surgically implanted for patients who are at risk of sudden cardiac arrest.
What is Medtronic announcing about the Sprint Fidelis Leads?
Medtronic, Inc., is announcing that it is voluntarily suspending worldwide distribution of the Sprint Fidelis family of defibrillation leads. This includes four Sprint Fidelis Models: 6930, 6931, 6948, and 6949. FDA considers this removal action to be a medical device recall. Medtronic is advising physicians to stop implanting the leads and to return unused products to the firm.
How do I know if I have a Sprint Fidelis lead?
You may have a patient card that identifies the implanted devices you have. If you have any uncertainty about your devices, you should contact your physician.
Does this action affect other Medtronic devices?
This action does not affect patients who have Medtronic devices that are pacemakers. While defibrillators keep the heart from going too fast, pacemakers keep the heart from going too slowly. This action also does not affect patients who have Medtronic ICDs or CRT-Ds without a Sprint Fidelis lead.
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.
Why are the Sprint Fidelis Leads being recalled?
The devices are being recalled because of the potential for lead fractures. These electronic wires are prone to fracture in a small number of patients. This could cause the defibrillator to deliver unnecessary shock or to not operate at all. Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis lead may have been a possible or likely contributing factor.
How many people have had this device implanted?
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.
What should patients do if they have had 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.
- Patients should not routinely seek removal of the device. The risks of removal in most patients exceed the small risk of lead fractures. Therefore, 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.
- Patients can call Medtronic at this toll-free number: 1-800-551-5544, ext. 41835.
What additional advice has been given to protect patient health?
Medtronic has 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 patient management recommendations are available at http://www.medtronic.com/fidelis/