BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONIST X4 CRT-P

    MDR report key: 21230057 · Received January 24, 2025

    Report

    Report Number
    2124215-2025-03407
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    November 3, 2024
    Report Date
    January 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NKE
    UDI-DI
    00802526559471
    PMA / PMN Number
    P030005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN OUT-OF-RANGE (OOR) MEASUREMENT OF >3000 OMHS, WITH RECENT NOISE EPISODES CAUSING PACING INHIBITION FOR OVER 2 SECONDS. RECOMMENDATIONS WERE PROVIDED TO OPTIMIZE PROGRAMMING WHILE MONITORING THE LEAD'S PERFORMANCE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THIS LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722003 VISIONIST X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) NKE BOSTON SCIENTIFIC CORPORATION U228 733837 00802526559471

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male