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.