BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANT? X4 CRT-D

    MDR report key: 24100641 · Received January 16, 2026

    Report

    Report Number
    2124215-2026-03287
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589287
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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) APPROPRIATELY BLANKED A PREMATURE VENTRICULAR CONTRACTION (PVC) AND THE LEFT VENTRICULAR PROTECTION PERIOD (LVPP) INHIBITED THE LEFT VENTRICULAR PACE. TECHNICAL SERVICES (TS) RECOMMENDED POTENTIAL PROGRAMMING OPTIONS. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162976 VIGILANT? X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR NIK BOSTON SCIENTIFIC CORPORATION G247 302481 00802526589287

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female