BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLTER VALVE

    MDR report key: 39580 · Received September 26, 1996

    Report

    Report Number
    8031062-1996-00001
    Event Type
    Injury
    Date Received
    September 26, 1996
    Report Date
    September 26, 1996
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOTH VALVES WERE PLACED IN THE SAME PT. EACH MALFUNCTIONED WITHIN 3 DAYS OF IMPLANTATION. "NOTE: SEE DEVICE MFGS REPORT 8031062-1996-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLTER VALVE Implant HYDROCEPHALUS SHUNT VALVE JXG JOHNSON & JOHNSON PROFESSIONAL, INC. NA HM02

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention