BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALITUDE X4 CRT-P

    MDR report key: 18494622 · Received January 11, 2024

    Report

    Report Number
    2124215-2024-01270
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NKE
    PMA / PMN Number
    P030005/S113
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BI-VENTRICULAR (BI-V) TRIGGER FEATURE POTENTIALLY CAUSED A NON-SUSTAINED VENTRICULAR TACHYCARDIA. TECHNICAL SERVICES COULD NOT COMPLETELY CONFIRM THIS BUT CONSERVATIVELY RECOMMENDED TO TURN OF THE BI-V TRIGGER FEATURE OFF. THIS CRT-P REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888437 VALITUDE X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) NKE BOSTON SCIENTIFIC CORPORATION U128 761228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other