Update on high battery impedance which may initiate Safety Mode in INGENIO™ family of DR EL pacemakers and CRT-Ps
Healthcare professional
Industry member
Medical devices
13 December 2023
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Update on high battery impedance which may initiate Safety Mode in INGENIO™ family of DR EL pacemakers and CRT-Ps
A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd as a follow-up to their earlier communication in June 2021, to update healthcare professionals on the additional information available and new patient management recommendations for all users of the remaining INGENIO™ family of dual chamber extended life (DR EL) pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). As shared previously, the INGENIO™ family of DR EL pacemakers and CRT-Ps may enter Safety Mode later in device life due to increased battery impedance. Additional post-market surveillance data from the affected device population has revealed other possible causes of safety mode initiation and patient management recommendations have been updated. 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.
