BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOMENTUM CRT-D

    MDR report key: 21405982 · Received February 18, 2025

    Report

    Report Number
    2124215-2025-09641
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    February 5, 2025
    Report Date
    February 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589102
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED IN FOR REVIEW OF DEVICE DATA FOR THIS PATIENT WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES (TS) REVIEWED THE PRESENTING ELECTROGRAM (EGM) AND FOUND THERE IS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). IN WHICH THE LEFT VENTRICULAR (LV) IS OVERSENSING THE AF AND IS INHIBITING PACING. ADDITIONALLY, TS REVIEWED A STORED VENTRICULAR EPISODE IN WHICH THERE WAS OVERSENSING AND UNDERSENSING DUE TO LOW R WAVES RESULTING IN AN INAPPROPRIATE PACE. TECHNICAL SERVICES PROVIDED PROGRAMMING RECOMMENDATIONS. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED IN FOR REVIEW OF DEVICE DATA FOR THIS PATIENT WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES (TS) REVIEWED THE PRESENTING ELECTROGRAM (EGM) AND FOUND THERE IS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). IN WHICH THE LEFT VENTRICULAR (LV) IS OVERSENSING THE AF AND IS INHIBITING PACING. ADDITIONALLY, TS REVIEWED A STORED VENTRICULAR EPISODE IN WHICH THERE WAS OVERSENSING AND UNDERSENSING DUE TO LOW R WAVES RESULTING IN AN INAPPROPRIATE PACE. TECHNICAL SERVICES PROVIDED PROGRAMMING RECOMMENDATIONS. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59112 MOMENTUM CRT-D IMPLANTABLE DEVICE NIK BOSTON SCIENTIFIC CORPORATION G124 504682 00802526589102

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male