BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER

    MDR report key: 1936095 · Received December 13, 2010

    Report

    Report Number
    1226348-2010-00430
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    December 6, 2010
    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 Location
    JA
    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 IMPLANTATION, OVER DRAINAGE WAS NOTED. THEN, IT WAS FOUND THROUGH X-RAY THAT THE PRESSURE HAD CHANGED FROM 100MMH2O AND 70MMH2O AUTOMATICALLY. AS A RESULT THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC, MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK