BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 13262055 · Received January 14, 2022

    Report

    Report Number
    2124215-2021-39875
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    November 18, 2021
    Report Date
    March 9, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Removal / Correction Number
    Z-0936-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 AN ADVISORY COMMUNICATION IN AUGUST 2019 REGARDING A SUBSET OF EMBLEM DEVICES THAT HAS AN ELEVATED POTENTIAL OF EXHIBITING THIS BEHAVIOR; THE POPULATION OF DEVICES THAT MAY BE IMPACTED WAS EXPANDED IN DECEMBER 2020. THIS PARTICULAR DEVICE IS INCLUDED IN THE EMBLEM S-ICD ACCELERATED DEPLETION ADVISORY POPULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE A219/203737 WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION (PBD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE A219/(B)(6) WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION (PBD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017893 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BOSTON SCIENTIFIC CORPORATION A219 203737 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention| H