Update on EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) with an elevated likelihood for early replacement

A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd to update healthcare professionals that the approximate active implanted population size of the EMBLEM™ Subcutaneous Implantable Defibrillators (S-ICDs) (Models A209 and A219) with an elevated likelihood for early replacement has been expanded to 38,350, since the earlier communication in August 2019 which reported 400 affected EMBLEM™ S-ICDs. This issue is due to compromised electrical performance of a low voltage capacitor causing premature battery depletion. As Boston Scientific has transitioned S-ICDs to an alternative low voltage capacitor since August 2018 to resolve this issue, no more affected devices are available for implantation. Healthcare professionals are advised to conduct remote monitoring and three-monthly device follow-up to facilitate detection and timely replacement of affected devices. Healthcare professionals may refer to the recommendations in the letter to manage the potential battery depletion behaviour of the affected implanted devices. 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.