BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1910410 · Received November 18, 2010

    Report

    Report Number
    1226348-2010-00385
    Event Type
    Injury
    Date Received
    November 18, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE VENTRICLES OF THE PT'S BRAIN BECAME TOO LARGE DUE TO DRAINAGE FAILURE. THE VALVE NEEDED TO BE REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention