BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 10331732 · Received July 28, 2020

    Report

    Report Number
    2124215-2020-15681
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 28, 2020
    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 Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT WAS IN VENTRICULAR TACHYCARDIA AND ALSO HAD T-WAVE OVERSENSING WHICH REQUIRED TWO SHOCK TO CONVERT THE PATIENT FROM THEIR ARRHYTHMIA. THESE SHOCKS ARE CONSIDERED INAPPROPRIATE SHOCKS AS THEY WERE A RESULT OF T-WAVE OVERSENSING. THE PATIENT WAS IN TRIGEMINY AND WAS HOSPITALIZED. IT WAS ALSO NOTED THAT THE PATIENT'S SYSTEM IS NOT FULLY OPTIMIZED BUT THAT IS CONSIDERED PHYSICIAN DISCRETION. SYSTEM REMAINS IN SERVICE AND THE FIELD REPRESENTATIVE DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THIS PATIENT. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795798 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 238876 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R