BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOMENTUM CRT-D

    MDR report key: 24052891 · Received January 13, 2026

    Report

    Report Number
    2124215-2026-02088
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589119
    PMA / PMN Number
    P010012/S436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPROGRAMMED FROM DDDR TO VVIR DURING AN IN CLINIC FOLLOW UP. SUBSEQUENTLY, THE BIV PACING PERCENTAGE WAS NOTED TO HAVE DECREASED. TECHNICAL SERVICES (TS) REVIEWED A COPY OF STORED DEVICE DATA FROM THE REMOTE HOME MONITORING SYSTEM AND NOTED THAT ON THE INTERVALS ABOVE THE LOWER RATE LIMIT (LRL) OF 60, THE LEFT VENTRICULAR (LV) SENSE WAS PRECEDING THE RIGHT VENTRICULAR (RV) SENSE. THIS RESULTED IN LV PACING BEING INHIBITED FOLLOWED BY AN RV PACE. TS DISCUSSED THE POTENTIAL OF TRYING A DIFFERENT LV SENSING VECTOR, TURNING LV SENSING OFF, OR INCREASING THE LRL. NO FURTHER ASSISTANCE WAS REQUESTED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119035 MOMENTUM CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G124 525664 00802526589119

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male