BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANT? X4 CRT-D

    MDR report key: 23712457 · Received December 4, 2025

    Report

    Report Number
    2124215-2025-89004
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    June 27, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589287
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING OF AN ATRIAL SIGNAL ON THE LEFT VENTRICULAR (LV) LEAD. THIS RESULTED IN THE INHIBITION OF THE LV PACE. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS AND RECOMMENDED TO HAVE AN X RAY REVISION OF THE LEAD. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802053 VIGILANT? X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) NIK BOSTON SCIENTIFIC CORPORATION G247 335691 00802526589287

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female