BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 259412 · Received January 21, 2000

    Report

    Report Number
    1219655-2000-00013
    Event Type
    Injury
    Date Received
    January 21, 2000
    Report Date
    January 21, 2000
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC. MEDOS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT ON OCT. 25, 1999 DOCTOR WAS UNABLE TO CHANGE VALVE PRESSURE BY USING A PROGRAMMER OR BY INJECTING SALINE. THE VALVE FUNCTIONED ERRATICALLY AND WAS EXPLANTED IN 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG JOHNSON & JOHNSON PROFESSIONAL, INC. MEDOS S.A. NA PG7121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention