BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 20753640 · Received November 21, 2024

    Report

    Report Number
    2124215-2024-73665
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 31, 2024
    Report Date
    November 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TESTING OF A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) IMPLANT, THE DEFIBRILLATION THRESHOLD TEST (DFT) FAILED. A SECOND DFT WAS THEN PERFORMED AND WAS SUCCESSFUL. A THIRD DFT WAS PERFORMED AND AGAIN FAILED. IT WAS NOTED THAT THE ELECTRODE APPEARED TO BE IN GOOD POSITION. THE S-ICD WAS FLUSH WITH THE RIBS. THE PHYSICIAN DECIDED TO MOVE THE S-ICD SLIGHTLY SUPERIORLY. A DFT WAS SUCCESSFULLY PERFORMED IN THE NEW POSITION. THE S-ICD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777313 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BOSTON SCIENTIFIC CORPORATION A219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other