MEDTRONIC DEFIBRILLATOR LEAD RECALL: MEDTRONIC RECALL INFORMATION

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Medtronic Recall

Medtronic has removed its Sprint Fidelis defibrillator leads from the market because they may fracture, which can cause the defibrillator to deliver unnecessary shocks or not operate at all. This is considered a Medtronic recall. Some deaths, at least 13, and major complications have occurred after the leads have fractured (Medtronic is reporting 13 deaths, but at least 46 deaths have been alleged to be associated with a Medtronic Sprint Fidelis defibrillator lead.)

A defibrillator lead connects the defibrillator, which is implanted near the shoulder, to the heart. If a lead fractures, it may send false signals to the defibrillator, causing the defibrillator to deliver unnecessary shocks or, in some cases, not to pace or shock when needed. Our clients have explained that the shocks are quite painful and that the fear of experiencing additional shocks is intense.

More than 268,000 recalled Medtronic leads were used with various defibrillators. Patients should consult their doctors regarding their defibrillator leads, and if a Sprint Fidelis defibrillator lead is involved, they should discuss what course of action to take.

The FDA has provided the following explanation of the defect and recommendations regarding the Sprint Fidelis defibrillator leads:

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.

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