Last December, Boston Scientific issued a voluntary notice outlining issues with a subpopulation of Accolade, Proponent, Essentio and Altrua 2 dual-chamber standard life and dual-chamber extended life pacemakers and Visionist and Valitude cardiac resynchronization therapy pacemakers (CRT-Ps).
Affected devices have an increased potential to initiate “Safety Mode” during telemetry or other normal, high-power operations. This occurs because of high battery impedance, underpowering the device system. The company attributed this to a manufacturing issue.
Boston Scientific reported two deaths in pacemaker-dependent patients implanted with devices from the subpopulation of devices that initiated Safety Mode in an ambulatory setting. Today’s FDA notice disclosed 832 injuries related to the issue.
The FDA said the recall — the most serious type — may involve the need for device explant. Using affected devices may cause serious adverse health consequences. Those include slow heartbeats (bradycardia), fainting (syncope) and death.
More on the Boston Scientific recall
Safety mode, an intended feature, activates during critical component failures. If the affected device enters safety mode, early device replacement is required, the FDA notice said.
When the device experiences three power-on resets within 48 hours due to battery issues, it initiates safety mode. Once the device enters safety mode, it can’t be reversed and may cause the devices to provide only unipolar sensing and pacing. That can lead to serious injury or death due to interruption of pacing.
Boston Scientific previously said the potential for this issue increases when the device reaches approximately four years or less of remaining battery longevity. No devices within the advisory population remain available for implant. The company said in December that it plans to implement updated manufacturing work instructions for the process used to make cathodes for Accolade product batteries. It also intends to develop a software update to detect battery health in all Accolade pacemaker devices.
Users with Accolade devices should immediately have their device replaced if it enters safety mode and they’re at high risk of harm associated with interrupted pacing. The notice recommends non-urgent replacement for other patients. Users should not rely on battery life estimates in safety mode and should conduct system follow-ups (remote or in-office) at least once every 12 moths.
What the company said when it initially warned on the pacemakers
A company spokesperson issued the following statement to MassDevice via email in December 2024:
Boston Scientific voluntarily issued a product advisory involving a subset of specific types of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) because of the potential for these devices to transition to Safety Mode due to an elevated internal battery impedance. This behavior can occur later in device life and may require early replacement for some patients. No devices within the advisory population remain available for implant.
Physicians following patients with devices included in the advisory population have been given recommendations intended to mitigate the risk of the behavior and will reach out to patients directly if a separate appointment should be made to assess their device.
