A company is suspending distribution of defibrillation leads used in heart patients because there's a risk they might fracture, with potentially serious consequences.
Defibrillation leads are implanted in patients and used to deliver an electric shock to the heart to correct any abnormal beating. Medtronic says fractures in some Sprint Fidelis models of its defibrillation leads may have contributed to the deaths of five patients.
The company is asking doctors to stop implanting the leads and to return any unused ones. But it isn't recommending that patients with such leads have them removed, since that could make them more likely to have complications.
Medtronic says doctors can reprogram the device to let a patient know that a fracture may have happened.
Medtronic and the FDA estimate that fractures have occurred in less than one percent of more than 268,000 leads that have been implanted.