BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 18576579 · Received January 24, 2024

    Report

    Report Number
    2124215-2024-03798
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    January 26, 2023
    Report Date
    January 24, 2024
    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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DELIVERED AN INAPPROPRIATE SHOCK DUE TO LOW SIGNAL AMPLITUDE AND OVERSENSED NOISE. TECHNICAL SERVICES (TS) WAS CONTACTED, AND TS DISCUSSED POSSIBLE CAUSES SUCH AS ELECTROMAGNETIC INTERFERENCE (EMI). THE S-ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING NOISE WAS REPRODUCED WITH ISOMETRICS AND HAVING THE PATIENT LYE ON THEIR STOMACH, BUT IN NO OTHER TESTS. IT WAS NOTED THE NOISE WAS APPROPRIATELY MARKED AND APPEARED DIFFERENT THAN THE PREVIOUSLY REPORTED NOISE. TS DISCUSSED PROGRAMMING OPTIONS, BUT NOT CHANGES WERE MADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE S-ICD DELIVERED ANOTHER INAPPROPRIATE SHOCK DUE TO NOISE AND T-WAVE OVERSENSING. TS AGAIN DISCUSSED PROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247435 EMBLEM MRI S-ICD IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION A219 152662 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other