BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 22460407 · Received July 9, 2025

    Report

    Report Number
    2124215-2025-45788
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    June 25, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526581519
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION. H6 FIELD: CODE ADDED: A070504.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS S-ICD WAS THOROUGHLY INSPECTED AND ANALYZED. A HIGH CURRENT DRAIN WAS DETECTED, BUT THE BATTERY STILL SUPPORTED FULL DEVICE FUNCTION. DETAILED ANALYSIS CONFIRMED THE IDENTIFIED HIGH CURRENT DRAIN WAS A RESULT OF A COMPROMISED CAPACITOR. THIS RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION. IT WAS DETERMINED THAT THE CAPACITOR WAS COMPROMISED DUE TO THE PRESENCE OF EXCESS HYDROGEN IN THE DEVICE CASE. BOSTON SCIENTIFIC ISSUED A FIELD SAFETY NOTICE REGARDING A SUBSET OF EMBLEM DEVICES THAT HAVE A POTENTIAL OF EXHIBITING THIS BEHAVIOR. THIS PARTICULAR DEVICE IS INCLUDED IN THE EMBLEM S-ICD ACCELERATED DEPLETION ADVISORY POPULATION. CORRECTION. H6 FIELD: CODE ADDED: A070504.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING EXPLANT PROCEDURE A BATTERY DEPLETION ERROR CODE WAS FOUND IN THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD). THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING EXPLANT PROCEDURE A BATTERY DEPLETION ERROR CODE WAS FOUND IN THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD). THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING EXPLANT PROCEDURE A BATTERY DEPLETION ERROR CODE WAS FOUND IN THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD). THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130068 EMBLEM MRI S-ICD SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) LWS BOSTON SCIENTIFIC CORPORATION A219 228977 00802526581519

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R