BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 17233229 · Received June 29, 2023

    Report

    Report Number
    2124215-2023-34170
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    June 12, 2023
    Report Date
    June 29, 2023
    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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DELIVERED TWO SEPARATE INAPPROPRIATE SHOCKS ON TWO DIFFERENT DAYS DUE TO T-WAVE OVERSENSING. THE T-WAVE OVERSENSING WAS REPRODUCIBLE IN THE CLINIC BY HAVING THE PATIENT LYE ON THEIR LEFT SIDE WITH ARMS ABOVE THEIR HEAD IN THE SECONDARY SENSING VECTOR. SUBSEQUENTLY, THE S-ICD WAS REPROGRAMMED TO THE PRIMARY VECTOR WHICH HAD A CLEAN SUBCUTANEOUS ELECTROCARDIOGRAM (SECG) WHEN IN THE SAME POSITION. THE S-ICD SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758399 EMBLEM MRI S-ICD IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION A219 226419 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other