BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE MICRO VALVE

    MDR report key: 5983052 · Received September 28, 2016

    Report

    Report Number
    1226348-2016-10686
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    August 4, 2016
    Manufacturer
    CODMAN & SHURTLEFF, 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 A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE VALVE WAS VISUALLY INSPECTED IT WAS NOTED THAT THE STATOR WAS DISLODGED. THEREFORE; THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. THE VALVE WAS HYDRATED FOR 24 HOURS. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, NO LEAKS WERE NOTED. THE VALVE WAS DRIED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: A CRACK IN THE VALVE CASING WAS NOTED. THIS IS PROBABLY DUE TO THE VALVE RECEIVING SOME FORM OF IMPACT. CORROSION WAS NOTED ON THE STATOR. THE CAM MAGNETS WERE CONTROLLED. THE MAGNETS PASSED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3112, WITH LOT CTPBCT, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 14TH JANUARY 2016. THE ROOT CAUSE OF THE CORROSION COULD NOT BE CLEARLY DETERMINED. THE ROOT CAUSES FOR THE DISLODGED STATOR COULD BE PARTLY DUE TO THE VALVE RECEIVING SOME FORM OF IMPACT, AS WELL AS THE CORROSION. 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.

    Description of Event or Problem · 1

    VALVE IS NOT ADJUSTABLE, DRAINED INSUFFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635611 HAKIM PROGRAMMABLE MICRO VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTPBCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention