BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 4791379 · Received May 22, 2015

    Report

    Report Number
    1226348-2015-10288
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 23, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PN/A
    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 UPON VISUAL EXAMINATION OF THE VALVE REVEALED THAT THE STATOR WAS DISLODGED FROM THE BASEPLATE.-THEREFORE; THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: NO DAMAGE TO THE VALVE CASING WAS NOTED. SOME CORROSION WAS NOTED ON THE STATOR. THE LOT HISTORY RECORD OF THE VALVE PRODUCT CODE 82-3100, WITH LOT CGFB10 WAS REVIEWED FOR COMPLETENESS DURING THE RELEASE PROCESS TO INVENTORY. AT THAT TIME BASED ON THE FACT THAT NO DISCREPANCIES WERE NOTED FOR THE PRODUCTS BEING ACCEPTED, THEY WERE RELEASED TO STOCK ON THE 1ST JUNE 2006. THE ROOT CAUSE(S) OF THE DISLODGEMENT OF THE STATOR COULD NOT BE DETERMINED. DR WAS INITIATED TO COLLECT DATA RELATED TO GALVANIC CORROSION WITHIN STATOR OF HAKIM VALVES. 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

    AFTER IMPLANTATION OF THE DEVICE, THE PATIENT VISITED THE HOSPITAL DUE TO STAGGERING GAIT IN (B)(6) 2014. WHEN THE SURGEON TRIED TO REPROGRAMING AFTER MIR SCANNING, THE SETTING PRESSURE COULD NOT BE CHANGED BY THE PROGRAMMER UNDER RADIOGRAPHY, AND IT WAS SET AT 100MMH2O BY USING NEODYMIUM. IN (B)(6) 2014, THE PATIENT VISITED THE HOSPITAL AGAIN DUE TO A FALL. SINCE THE SETTING PRESSURE HAD CHANGED TO 200MMH2O, IT WAS SET AT 100MMH2O BY USING NEODYMIUM AGAIN. HOWEVER, AT FOLLOW-UP VISIT, IT WAS FOUND THE PRESSURE HAD CHANGED TO 80MMH2O. THE DEVICE WAS REPLACED WITH THE SAME NEW PRODUCT AT 100MMH2O IN (B)(6) 2015. THE PATIENT¿S CONDITION IS GOOD AFTER THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334302 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CGFB10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention