BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 6012300 · Received October 7, 2016

    Report

    Report Number
    1226348-2016-10715
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    August 16, 2016
    Manufacturer
    JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A
    Product Code
    JXG
    PMA / PMN Number
    K980778
    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 50MMH2O. THE VALVE WAS HYDRATED FOR 24 HOURS. THE VALVE WAS VISUALLY INSPECTED: SOME BIOLOGICAL DEBRIS WAS NOTED INSIDE THE VALVE. THE VALVE WAS TESTED FOR PROGRAMMING. WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4) AND PROGRAMMER 82-3190 WITH SERIAL NUMBER (B)(4), THE VALVE FAILED THE TEST, THE CAM MECHANISM DID NOT MOVE DURING THE PROGRAMMING PROCESS. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, NO LEAKS NOTED. THE CATHETERS WERE IRRIGATED, NO OCCLUSION WAS NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE FAILED THE TEST. THE VALVE WAS DRIED. THE VALVE WAS THEN PRESSURE TESTED AT 50MMH2O, FAILED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. THE CAM MAGNETS WERE ALSO CONTROLLED. THE MAGNETS PASSED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3114, WITH LOT CTCBGP, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 13TH MARCH 2015. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS DUE TO THE BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. 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

    UDI: (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE VALVE DIDN'T FLOW ANY LONGER. IMPLANTATION:? EXPLANTATION: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663086 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A CTCBGP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention