BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 4812604 · Received June 2, 2015

    Report

    Report Number
    1226348-2015-10314
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    April 27, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    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

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 170MMH2O. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED, NO LEAKS WERE NOTED. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE NS9008 WITH LOT CLGCKR, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 5TH JULY 2010. NO ROOT CAUSE COULD BE DETERMINED AS THE PROBLEM REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. THE VALVE PROGRAMMED. 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 DEVICE WAS IMPLANTED VIA L-P SHUNT TO A MALE PATIENT. ON (B)(6) 2015, THE DEVICE WAS REMOVED SINCE THE SETTING PRESSURE COULD NOT BE CHANGED. FURTHER INFORMATION WOULD BE PROVIDED AS SOON AS (B)(4) RECEIVE IT FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356940 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CLGCKR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention