Advisory subset of approximate 400 EMBLEM S-ICDs (Model A209 and A219) with elevated likelihood for early replacement
Healthcare professional
Medical devices
2 September 2019
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A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd to inform healthcare professionals (HCPs) of the performance of approximately 400 active worldwide EMBLEM™ S-ICDs that may result in a need for device replacement (ERI/EOL) earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion. These affected devices were not supplied locally. However, as the specific cause of the issue has not been identified, the occurrence of accelerated battery depletion in all other EMBLEM S-ICDs cannot be ruled out. HCPs are advised on the measures for managing patients implanted with the affected devices, which include 3-monthly device checks and device replacement within 21 days of ERI. HCPs are also reminded on the labelled recommendations for device monitoring and premature battery depletion mitigations for all EMBLEM S-ICDs. 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.
