BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 8505885 · Received April 11, 2019

    Report

    Report Number
    2124215-2019-05736
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    January 22, 2019
    Report Date
    April 11, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. DEVICE EVALUATED BY MFR: NO ANALYSIS AND NO PRR REQUIRED PER PIP # (B)(4) CRM AS-REPORTED ALLEGATIONS OF INFECTION, EROSION, AND MIGRATION

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS SYSTEM WAS REMOVED FROM SERVICE DUE TO EROSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299918 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 236234 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R