BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 1852413 · Received September 29, 2010

    Report

    Report Number
    1226348-2010-00314
    Event Type
    Injury
    Date Received
    September 29, 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 SINCE OVER DRAINAGE WAS NOTED, THE SURGEON ATTEMPTED TO CHANGE THE PRESSURE FROM 150MM H2O TO 180MM H2O. THE SURGEON EXPLAINED THAT THE DEVICE WOULD NOT PROGRAM TO THE DESIRED PRESSURE SETTING. AS A RESULT, THE DEVICE WAS REVISED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention