This month, Boston Scientific issued a notice to customers saying that it identified 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. This is attributed to a manufacturing issue.
The company reports two deaths in pacemaker-dependent patients implanted with devices from the subpopulation of devices that initiated Safety Mode in an ambulatory setting.
Boston Scientific 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.
Safety Mode has limited functionality and can lead to a pacemaker failing to properly regulate the heart’s rhythm and rate in some patients. Devices that enter Safety Mode need replacing, the FDA said. Boston Scientific 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.
The company said the issue affects a subset of approximately 13% of devices from the Accolade family, built before September 2018.
A notice to customers said: “Patient safety remains Boston Scientific’s highest priority, and we are committed to communicating up-to-date information with physicians and healthcare professionals to ensure you have timely, relevant information for managing your patients.”
A statement from Boston Scientific
A company spokesperson issued the following statement to MassDevice via email:
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.
