The FDA has issued a safety alert for some Boston Scientific Accolade pacemakers after reports of a battery-related manufacturing issue causing the devices to initiate safety mode. The devices have limited functionality when in safety mode and may be unable to provide optimal cardiac support.
Patients using Accolade, Proponent, Essentio, Altrua 2 Standard Life and Altrua 2 Extended Life pacemakers, as well as Visionist and Valitude cardiac resynchronization therapy pacemakers, may need to have their devices replaced earlier than anticipated, according to the FDA's Dec. 16 alert.
Two deaths have been reported in association with these devices, according to Boston Scientific.
The FDA recommends providers monitor patients using these pacemakers. If a patient exhibits symptoms that suggest the device may have initiated safety mode, surgery should be scheduled to replace the device.