BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANT X4 CRT-D

    MDR report key: 20661105 · Received November 12, 2024

    Report

    Report Number
    2124215-2024-70887
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589287
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) WAS ASKING ABOUT THE PROGRAMMING ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IF THEY SET IT TO 5 VOLTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IT WILL DOUBLE THE HIGHEST OF THE LAST 7 DAYS WITH SUCCESSFUL THRESHOLD TESTS AND WILL IMPACT DEVICE LONGEVITY. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977185 VIGILANT X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR NIK BOSTON SCIENTIFIC CORPORATION G247 258473 00802526589287

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male