BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE MICRO VALVE

    MDR report key: 6789332 · Received August 11, 2017

    Report

    Report Number
    1226348-2017-10575
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    June 7, 2017
    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 IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 160 MMH2O. THE VALVE WAS VISUALLY INSPECTED: A CLEAR LIQUID WAS NOTED INSIDE THE VALVE. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING WITH PROGRAMMER 82-3126 WITH SERIAL (B)(4), THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, ONLY LEAKED FROM THE NEEDLE HOLES OVER THE NEEDLE GUARD. 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 82-3112, WITH LOT CVFBY4 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 26TH MAY 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.

    Description of Event or Problem · 1

    BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569680 HAKIM PROGRAMMABLE MICRO VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CVFBY4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention