Device Information
The S-ICD system is designed to detect and treat life-threatening ventricular tachyarrhythmias.
Models Affected
EMBLEM S-ICD Model A209 and A219, SQ-RX S-ICD Pulse Generator Model 1010.
Software Update
Boston Scientific is developing software updates (V4.04 or higher) to mitigate the effects of memory corruption and prevent atypical energy delivery.
Recommendations
Continue using the S-ICD system as prescribed, and follow precautions identified in the user manual when radiation therapy is prescribed. No changes to clinical follow-up are recommended.
Additional Information
Patient safety is the highest priority. Boston Scientific is committed to transparent communication about matters of patient safety.
Manual:
Download: Important Medical Device Information: Subcutaneous Implantable Defibrillator (S-ICD) System
Chat: Powered By VoiceSphere