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Health Sciences Authority
Dear Healthcare Professional Letters

Potential risk of electrical overstress during delivery of high voltage therapy with EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (Models A209 and A219)

Audiences

Healthcare professional

Industry member

Product type

Medical devices

8 December 2020

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 Asia Pacific Pte Ltd to inform healthcare professionals of the potential for a specific subset of approximately 3,350 EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) to experience malfunction during high voltage therapy delivery, necessitating device replacement due to electrical overstress. The most common clinical harm associated with this malfunction is additional intervention required for early replacement of the implanted device. No serious injuries have been reported and no affected S-ICDs remain available for implant. Prompt replacement of any affected EMBLEM™ S-ICD suspected of exhibiting electrical overstress is recommended. While prophylactic device replacement is not required routinely, it may be considered in cases of high risk for life-threatening harm or other relevant considerations, after taking individual patient preferences and circumstances into account through a process of shared decision-making. Healthcare professionals are advised to follow-up with their patients and monitor them through the LATITUDE NXT Remote Patient Management System to facilitate prompt detection of accelerated battery depletion or device-related alert conditions during the interval between in-office device checks. 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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