BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN HAKIM PROG VALVE W/ IN-LINE RESERVOIR & SG

    MDR report key: 3666700 · Received March 7, 2014

    Report

    Report Number
    1226348-2014-11290
    Event Type
    Injury
    Date Received
    March 7, 2014
    Date of Event
    February 20, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    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.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: THERE WAS A SHUNT OPERATION (82-3113) ON THE (B)(6) 2013. AFTERWARDS, THE HCP TRIED TO CHANGE SHUNT PRESSURE SETTING SEVERAL TIMES BUT THERE WAS CONTINUOUSLY OVER DRAINAGE, THUS, THE HCP DECIDED A SHUNT REVISION. AND THERE WAS THE SHUNT REVISION OPERATION (80-3162) ON THE (B)(6) 2014 AND EVEN THOUGH THE HCP DID SHUNT PRESSURE SETTING CHANGES SEVERAL TIMES, THERE WAS UNDER DRAINAGE AT THIS TIME CONTINUOUSLY, SO THE HCP DECIDED ANOTHER SHUNT REVISION. THE SECOND SHUNT REVISION (82-3100 WILL BE USED) IS NOT YET BEEN TAKEN PLACE. UNFORTUNATELY THE HCP ALREADY DISCARDED, THE DEFECTIVE SHUNT (82-3113) RIGHT AFTER THE REVISION. SO ONLY THE SECOND SHUNT (80-3162) WILL BE RETURNED AFTERWARDS. (AFTER USE ON PATIENT) THE PATIENT HAS BEEN HOSPITALIZED DUE TO UNDER DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140401 CODMAN HAKIM PROG VALVE W/ IN-LINE RESERVOIR & SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention