BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOMENTUM EL ICD DR

    MDR report key: 19516052 · Received June 11, 2024

    Report

    Report Number
    2124215-2024-35741
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    February 20, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526587726
    PMA / PMN Number
    P960040/S385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN A VALID RADIO FREQUENCY OVERUSE CONDITION (FOC). A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE REPORTED A MEDIUM RADIO FREQUENCY INTERFERENCE. AT THIS TIME THE FOC HAS CAUSED AN UNEXPECTED DECREASE IN BATTERY LIFE. VARIOUS PROCEDURAL AND PROGRAMMING OPTIONS WERE DISCUSSED FOR THIS ICD IN ORDER TO SAVE BATTERY LIFE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157901 MOMENTUM EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BOSTON SCIENTIFIC CORPORATION D121 233017 00802526587726

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male