BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 3231275 · Received July 17, 2013

    Report

    Report Number
    1226348-2013-21343
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 9, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE ACCUMULATIONS OF BIOLOGICAL DEBRIS WITHIN THE VALVES, WHICH HAVE RESULTED IN BLOCKAGES WITHIN THE DEVICES. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE DEVICE WAS IMPLANTED VIA V-P SHUNT. IT WAS NOTED THAT THE VENTRICLES OF THE PATIENT¿S BRAIN BECAME ENLARGED. AN IMAGE WAS TAKEN AND IT WAS NOTED THAT THE VENTRICULAR CATHETER WAS OBSTRUCTED. AS A RESULT, THE DEVICE WAS REPLACED DUE TO A BLOCKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331553 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention