WASHINGTON – Medtronic Inc. has suspended distribution of its Sprint Fidelis defibrillation leads after identifying five patient deaths in which a lead fracture may have been a contributing factor.
A defibrillator monitors a patient's heartbeat; if it senses an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart.
Medtronic said Monday it had discovered a "small chance of fractures in particular locations" on Sprint Fidelis models 6930, 6931, 6948 and 6949. The company is asking doctors to stop implanting the leads and return all unused leads to Medtronic.
A fractured lead "can cause the defibrillator to deliver unnecessary shocks or not operate at all," said Daniel Schultz, director of the Food and Drug Administration's Center for Devices and Radiological Health.
The company is not recommending that patients with such a lead have it removed, since they "are more likely to experience complications from removal." Instead, Medtronic said, doctors can reprogram the device to alert the patient that a fracture may have occurred. Possible indicators could include audible alerts or inappropriate shocks.
"We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect," Schultz said. "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."
More than 268,000 of the leads have been implanted. Medtronic and the FDA estimated that fractures have occurred in less than 1 percent of those leads.
Medtronic senior vice president Pat Mackin emphasized that the company's action does not apply to Medtronic pacemakers.
Medtronic advises patients with Sprint Fidelis leads to contact their doctor's office. Patients who are unsure about whether they have a Sprint Fidelis lead can contact Medtronic Patient Services at 1-800-551-5544, extension 41835, or visit http://www.medtronic.com/fidelis.