BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/ PRECHAMBER

    MDR report key: 1150499 · Received September 5, 2008

    Report

    Report Number
    1226348-2008-00229
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    May 1, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./ MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT AFTER A NUCLEAR SPIN TOMOGRAPHY AN X-RAY OF THE SKULL WAS MADE. THE IMAGE SHOWED THAT THE WHEEL OF THE VALVE WHERE YOU CAN MAKE ADJUSTMENTS WAS DISPLACED. CLINICAL CONSEQUENCES WAS OVER DRAINAGE. THE VALVE WAS IMPLANTED IN EARLY 2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE W/ PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./ MEDOS S.A. NA PJ 8258

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention