Issues with the leads was first noted in March and physicians were notified. Data accumulated since has prompted Medtronic to stop producing, selling, and distributing the Spring Fidelis leads. Products currently on shelves should be returned to Medtronic.

The defibrillator leads recall does not, however, necessitate the surgical removal of already implanted devices at this time; an adjustment of the defibrillator’s settings is recommended. While the rate of adverse effects is currently less than 1%, it is unknown if this rate will increase as more time passes and leads have been in place for longer.

Adverse effects may include major complications or even death. Medtronic has identified five cases in which the faulty leads may be responsible or a contributing factor in the death of the patient.

Patients currently implanted with affected devices–approximately 268,000 worldwide–should speak with their physicians. A small number of non-Medtronic defibrillators are also fitted with the Sprint Fidelis leads. Patients with another manufacturer’s device that utilize the faulty leads, or those unsure of their leads’ manufacturer, should contact their doctor.

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.

Background:

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.

The Sprint Fidelis leads are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy – Defibrillators (CRT-Ds). Approximately 268,000 Sprint Fidelis leads have been implanted worldwide. This action does not affect Medtronic pacemaker patients.

The U.S. Food and Drug Administration (FDA) intends to issue a public statement regarding Medtronic’s decision at www.fda.gov.

Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis.

This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Based on Medtronic’s extensive performance data, Sprint Fidelis lead viability is trending lower than Medtronic’s Sprint Quattro® lead at 30 months (97.7% Sprint Fidelis vs. 99.1% Sprint Quattro). 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.

Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output. Based on current information regarding the 268,000 implanted leads, Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.

“There is nothing more important to us than the safety and well-being of patients,” said Bill Hawkins, president and chief executive officer of Medtronic. “We take all matters of product quality very seriously and believe this action is the right thing to do given currently available information.”

Medtronic Outreach to Physicians and Patients

In conjunction with Medtronic’s Independent Physician Quality Panel, Medtronic today communicated, via letter and direct outreach with more than 13,000 physicians worldwide, the Sprint Fidelis lead performance data and updated patient management recommendations for patients who are implanted with Sprint Fidelis leads. These recommendations include device programming and patient management recommendations that will ensure a patient’s device is set to more effectively monitor for potential problems and provide an audible alert in the event of lead fractures.

“Medtronic has acted responsibly to address concerns about the possibility of lead fractures and to minimize harm to patients,” said Kevin Hackett, M.D. of Columbus Cardiology Consultants and member of Medtronic’s Independent Physician Quality Panel. “The Physician Panel has reviewed Medtronic’s data and believes they are taking the correct action.”

Information for Patients

Medtronic recommends that patients, who believe they may have a Fidelis lead, consult with their physicians. It is important to note that Medtronic pacemaker patients are not affected by this action. Medtronic will communicate directly to affected patients and encourage them to contact their physicians for more information. Medtronic has established the following website – www.medtronic.com/fidelis – and a toll-free number (1-800-551-5544 ext. 41835) for patients seeking information.