BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHPV CYL W/LG RR NU120CM DIST

    MDR report key: 5647817 · Received May 11, 2016

    Report

    Report Number
    1226348-2016-10362
    Event Type
    Injury
    Date Received
    May 11, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK122118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS HYDRATED FOR ABOUT 25 HOURS. THE VALVE WAS VISUALLY INSPECTED: NEEDLE HOLES IN THE RICKHAM RESERVOIR WERE NOTED, AS WELL AS BIOLOGICAL DEBRIS IN THE VALVE. THE VALVE WAS TESTED FOR PROGRAMMING. WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4), THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED. THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED, BIOLOGICAL DEBRIS WAS FLUSHED OUT. THE VALVE WAS LEAK TESTED, ONLY LEAKED FROM THE NEEDLE HOLES IN THE RICKHAM RESERVOIR. THE CATHETER WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS REFLUX TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS DRIED. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3852, WITH LOT CVBBVM, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 12TH FEBRUARY 2016. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. 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

    I WAS NOT PRESENT FOR THIS CASE. GOT A CALL AFTER THE CASE THAT THE CLINICIAN HAD DONE A SHUNT REVISION. I AM UNSURE OF THE CONDITION OF THE VALVE OR WHAT HAPPENED. I HAVE NOT BEEN ABLE TO SPEAK WITH THE DOCTOR DIRECTLY. HE ASKED THE STAFF TO CONTACT ME AND TO SEND THE VALVE IN FOR INSPECTION. I DO NOT HAVE ANY OTHER DETAILS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301761 CHPV CYL W/LG RR NU120CM DIST SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CVBBVM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention