BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 4862061 · Received June 23, 2015

    Report

    Report Number
    1226348-2015-10365
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 30, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    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, IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 60MMH2O. THE VALVE WAS VISUALLY INSPECTED: NEEDLE HOLES IN THE NEEDLE CHAMBER WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED, ONLY LEAKED FROM THE NEEDLE HOLES IN THE NEEDLE CHAMBER. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE FAILED THE TEST, DURING THE PROGRAMMING PROCESS THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS THEN PRESSURE TESTED AT 60MMH2O, THE VALVE FAILED THE TEST. 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 NS9008 WITH LOT CRMBW5, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 12TH NOVEMBER 2014. THE ROOT CAUSE OF THE PROBLEM REPORTED IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, 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

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

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE DEVICE WAS IMPLANTED VIA L-P SHUNT TO THE PATIENT WITH INPH ((B)(6)-YEAR-OLD MALE). THE INITIAL SETTING PRESSURE WAS 160MMH2O. THREE MONTHS AFTER THE IMPLANTATION, THE PATIENT HAD A GAIT DISORDER AND VENTRICULAR ENLARGEMENT WAS STILL OBSERVED THROUGH IMAGES. THE SURGEON TRIED TO LOWER THE PRESSURE TO 140MMH2O, BUT THE PRESSURE COULD NOT BE CHANGED BY THE PROGRAMMER EVEN AFTER FLASHING. THE SURGEON CHANGED THE PRESSURE TO 140MMH2O BY USING NEODYMIUM AND THEN LOWERED THE PRESSURE EVERY 2 WEEKS FROM 140MMH2O TO 100MMH2O TO 60MMH2O BY USING NEODYMIUM. HOWEVER, THE PATIENT¿S CONDITION DID NOT IMPROVE. ON (B)(6) 2015, THE REVISION SURGERY WAS CONDUCTED DUE TO SUSPECTED OCCLUSION AND ONLY THE VALVE WAS REPLACED WITH THE COMPETITOR¿S ONE (MEDTRONIC STRATA). THE PATIENT IS CURRENTLY BEING FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406133 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CRMBW5

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention