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Health Sciences Authority
Dear Healthcare Professional Letters

High battery impedance may initiate Safety Mode in a subset of ACCOLADE™ family of pacemakers and cardiac resynchronisation therapy pacemakers

Audiences

Healthcare professional

Industry member

Product type

Medical devices

26 December 2024

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Boston Scientific to inform healthcare professionals about a subset of pacemakers from the ACCOLADE™ family with an increased potential to initiate Safety Mode during telemetry or, in rare instances, other normal, higher-power operations due to latent, high battery impedance.  Unanticipated concentration of lithium salts resulting from variability of battery assembly techniques may lead to a lack of available electrolyte between the battery anode and cathode, resulting in high battery impedance. The affected devices were produced prior to September 2018 and are from a subpopulation of the ACCOLADE™, PROPONENT™, ESSENTIO™, and ALTRUA™ 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST™ and VALITUDE™ cardiac resynchronization therapy pacemakers (CRT-Ps). Boston Scientific will update all healthcare professionals when a software update to detect the onset of a high impedance battery state is available. Healthcare professionals are advised to promptly identify patients with likelihood of high battery impedance-induced Safety Mode and follow the recommended actions for device replacement and system follow-up. General prophylactic replacement is not recommended. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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