Urgent Field Safety Notice
Boston Scientific has released programmer software version 4.04 to address two previous Field Safety Notices.
S-ICD Behaviors Addressed
The version 4.04 S-ICD Programmer software addresses two behaviors:
- Unintended programmer command behavior due to RF interference.
- Memory corruption behavior leading to repeated atypical energy delivery.
Recommendations include upgrading Model 3200 S-ICD programmers with version 4.04 software and performing standard in-clinic S-ICD follow-up for all patients implanted with an S-ICD.
Boston Scientific emphasizes patient safety as its highest priority and provides contact information for additional questions or to report clinical events.
Manual:
Download: Boston Scientific S-ICD Programmer Software Version 4.04 User Manual
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