BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 6067502 · Received October 31, 2016

    Report

    Report Number
    1226348-2016-10768
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    September 24, 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: CORROSION WAS NOTED ON THE STATOR. THE CAM MAGNETS WERE CONTROLLED. THE MAGNETS FAILED. THE POLARITY OF THE MAGNETS WAS TESTED, THE MAGNETS WERE ALL ON -FAILED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3114, WITH LOT CMCCV3, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 21ST MARCH 2011. THE ROOT CAUSE OF THE DISLODGED STATOR COULD BE DUE TO CORROSION, THIS HOWEVER COULD NOT BE DETERMINED. THE ROOT CAUSE OF ABNORMAL POLARIZATION OF CHPV MAGNETS WAS PROBABLY CAUSED BY MAGNETIC FIELDS, THIS HOWEVER COULD NOT BE DETERMINED. 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

    THE ROTATOR FROM THE VALVE IS DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718299 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CMCCV3

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention