EMBLEMTM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) EMBLEMTM S-ICD Subcutaneous Electrode (Model 3501) User Manual

Important Medical Device Advisory Update

Boston Scientific is issuing a Field Safety Notice for EMBLEMTM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) and EMBLEMTM S-ICD Subcutaneous Electrode (Model 3501).

The notice addresses three separate and unrelated behaviors:

Elevated likelihood for early replacement due to accelerated battery depletion

This behavior affects a subset of approximately 38,350 active EMBLEM S-ICDs (Models A209 and A219) and can be detected by observing an unexpected decrease in Remaining Battery Life to ERI or an earlier than expected ERI/EOL battery status.

Potential for electrical overstress during delivery of high voltage therapy

Potential for electrode body fracture at a location distal to the proximal sense ring

Boston Scientific provides recommendations to manage these behaviors and is committed to the continual improvement of this important therapy in the interest of patient benefit and safety.

Manual:

Download: EMBLEMTM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) EMBLEMTM S-ICD Subcutaneous Electrode (Model 3501) User Manual

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