BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 5709895 · Received June 9, 2016

    Report

    Report Number
    1226348-2016-10419
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    May 12, 2016
    Manufacturer
    JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A
    Product Code
    JXG
    PMA / PMN Number
    PK980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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/PRESSURE COULD NOT BE DETERMINED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: 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 82-3114 WITH LOT CHCC2C, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 12TH APRIL 2007. THE ROOT CAUSE OF THE CORROSION COULD NOT BE CLEARLY DETERMINED. INVESTIGATION FOR THE CORROSION ISSUE ON HAKIM VALVES IS BEING FOLLOWED WITH CAPA. 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

    RESURGERY DUE TO MALFUNCTION OF THE VALVE. NOT ABLE TO REPROGRAM THE VALVE. PRODUCT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367025 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A CHCC2C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention