BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH SIPHONGUARD

    MDR report key: 2180632 · Received July 22, 2011

    Report

    Report Number
    2180632
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS PLACED. THE SURGEON STATES THAT THE VALVE HAD MALFUNCTIONED AND HAD TO BE REMOVED (COULD NOT PROGRAM). THE VALVE WAS REMOVED 6 DAYS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITH SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG CODMAN & SHURTLEFF, INC 82-3162 CLNBZR

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR