The FDA is boosting a recall effort from Boston Scientific regarding batteries potentially underpowering a number of the company’s implanted Accolade pacemakers, which may need to be replaced earlier than planned.
The medtech issued a notice (PDF) to healthcare providers this month saying that about 13% of the devices from the Accolade family are affected. That includes Proponent, Essentio and Altrua 2 standard- and extended-life, dual-chamber pacemakers as well as the Visionist and Valitude cardiac resynchronization therapy pacemakers, with all being manufactured before September 2018.
The company said certain battery production techniques previously used by a subset of manufacturers could lead to higher electrical impedance, raising the risk that the devices may be pushed into a limited safety mode following multiple system resets—triggered by transmitting data, for example, or performing other battery-draining operations.
Boston Scientific said it has seen two reported patient deaths linked to the issue. The devices continue to provide therapy while in the permanent safety mode, but under a set of backup parameters that may not match a particular user’s cardiac programming and heart rhythms, and battery reserves may not last as long as anticipated. The company said any implant that enters safety mode should be replaced.
The FDA said it is working with Boston Scientific to evaluate the potential risks in all Accolade pacemaker devices, and the agency has not yet issued a classification for the recall.
According to the company, about 70% of the safety mode events occurred during a patient’s clinic visit, while the device was connected to a Latitude programmer. Boston Scientific said it is currently developing a software update for its Accolade and Latitude hardware to help detect the onset of a high-impedance battery state, which will alert providers before the implant enters safety mode.