BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMABLE MICRO VALVE

    MDR report key: 6450245 · Received March 31, 2017

    Report

    Report Number
    1226348-2017-10218
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    March 8, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K980778
    Product Problem
    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 VALVE WAS VISUALLY INSPECTED IT WAS NOTED THAT THE STATOR WAS DISLODGED. THEREFORE; THE CAM POSITION/PROGRAMMING AND PRESSURE TEST COULD NOT BE DETERMINED. THE VALVE WAS HYDRATED. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, NO LEAKS WERE NOTED. THE CATHETERS WERE IRRIGATED, NO OCCLUSIONS WERE NOTED. THE VALVE WAS REFLUX TESTED. THE VALVE FAILED THE TEST. THE VALVE WAS DRIED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: A CRACK AND A SCRATCH MARK WERE NOTED IN THE VALVE CASING. 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 CHMBDG, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 30TH OCTOBER 2007. 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, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON FOUND THE IMPLANTED VALVE (DOI IS UNKNOWN) MADE UNUSUAL MOVEMENT WHEN ATTEMPTING TO CHANGE THE PRESSURE SETTING UNDER X-RAY ON (B)(6) 2017. THE SURGEON CONFIRMED THAT THE STEPPING MOTOR WAS DROPPED OFF FROM THE IMPLANTED VALVE¿S BASE PLATE BY X-RAY PHOTO. THE PRESSURE SETTING WAS UNKNOWN. THEN, THE SURGEON CHECKED PATIENT¿S HISTORICAL X-RAY PHOTOS AND FOUND THAT THE VALVE SEEMED TO BE ALREADY BROKEN FROM 2 YEARS AGO. THE PATIENT¿S CONDITION IS UNDER MONITORING. THE SURGEON COMMENTED THAT A REVISION SURGERY DOES NOT HAVE TO BE PERFORMED IMMEDIATELY, SO THE VALVE IS NOT REMOVED FROM THE PATIENT'S BODY YET. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232704 HAKIM PROGRAMMABLE MICRO VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CHMBDG

    Patients

    Seq Age Sex Outcome Treatment
    1