BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 2840748 · Received November 20, 2012

    Report

    Report Number
    1226348-2012-00616
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    November 7, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    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 THE PATIENT DEVELOPED ENLARGED VENTRICLES. DOCTOR CHANGED THE PRESSURE. GAIT DISORDER WAS NOTED. THE PRESSURE WAS CHANGED AGAIN. THE DEVICE WAS REVISED. IT WAS NOTED THAT THE LUMBAR CATHETER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention