BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 518566 · Received March 31, 2004

    Report

    Report Number
    1226348-2004-00095
    Event Type
    Injury
    Date Received
    March 31, 2004
    Date of Event
    January 22, 2004
    Report Date
    March 4, 2004
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL AFFIIATE REPORTS THE IMPLANTED VALVE COULD NOT BE REPROGAMMED AND THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG CODMAN & SHURTLEFF, INC. MEDOS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention