BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/PRECHAMBER

    MDR report key: 5776226 · Received July 7, 2016

    Report

    Report Number
    1226348-2016-10477
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    June 16, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS HYDRATED FOR ABOUT 25 HOURS. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS TESTED FOR PROGRAMMING. WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4), THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS LEAK TESTED, NO LEAKS WERE NOTED. THE VALVE WAS DRIED. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3110, WITH LOT CRFCHB, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 21ST MAY 2010. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    VALVE IMPLANTED 2010. NOW IT'S NOT ADJUSTABLE ANY MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430171 HAKIM PROGRAMMABLE VALVE W/PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CLFC4D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention