BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 11735764 · Received April 27, 2021

    Report

    Report Number
    2124215-2021-10409
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DID NOT CONVERT THE ARRHYTHMIA DURING DEFIBRILLATION THRESHOLD (DFT) TESTING AT IMPLANT AND IMPEDANCE MEASUREMENTS WERE HIGH AROUND 180 OHMS. DURING THE PROCEDURE THE ELECTRODE WAS REPOSITIONED AND THE IMPEDANCE DECREASED TO 130 OHMS. HOWEVER, THE ARRHYTHMIA STILL WAS NOT CONVERTED WITH ANOTHER DFT TEST. ONE MONTH LATER THE PATIENT WAS BROUGHT BACK INTO THE OFFICE TO DISCUSS HAVING AN ADDITIONAL DFT TEST. TECHNICAL SERVICES (TS) WAS CONSULTED AGAIN AND DISCUSSED THE POSITION OF THE DEVICE AND ELECTRODE. IT WAS NOTED THAT IF DFT TESTING DID NOT CONVERT THE ARRHYTHMIA DURING THE NEXT DFT TEST, THE PHYSICIAN WOULD CONSIDER REVISING THE ELECTRODE. TS DISCUSSED THE OPTION OF REPOSITIONING THE S-ICD AT THE SAME TIME AS BASED UPON IMAGING, IT APPEARED TO BE IMPLANTED MID-LINE AND MAY HAVE BETTER CONVERSION IF POSITIONED SLIGHTLY MORE POSTERIOR. THE FIELD REPRESENTATIVE REACHED OUT THE CLINIC AND DETERMINED THE PATIENT HAS NOT YET UNDER GONE A SECOND DFT TEST AT THIS TIME DUE TO PERSONAL CHOICE. THE S-ICD AND ELECTRODE REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626316 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 133494 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR