Boston Scientific S-ICD (SQ-RX S-ICD Model 1010, EMBLEM™ S-ICD Model A209 and EMBLEM™ MRI S-ICD Model A219) memory corruption advisory

Boston Scientific Asia Pacific Pte Ltd would like to inform healthcare professionals of a memory corruption incident of a Subcutaneous Implantable Defibrillator system (S-ICD), EMBLEM™ S-ICD Model A209, that led to atypical energy delivery preventing S-ICD arrhythmia detection/treatment and ultimately contributing to a patient death. The probability of corruption of the specific location in memory that produces this device behaviour within an S-ICD was determined to be approximately 1 in 300,000 over five years. Recurrence of this device behaviour is highly unlikely. Boston Scientific is currently developing an S-ICD software update to mitigate the issue. Healthcare professionals are recommended not to change clinical follow-ups due to this single event. Please refer to the letter for more 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.