BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM IN LINE PROGRAMMABLE VALVE

    MDR report key: 5660768 · Received May 17, 2016

    Report

    Report Number
    1226348-2016-10380
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    April 19, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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/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 82-3162 WITH LOT CKMBYT, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN (B)(6) 2009. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    INCONSISTENT WHEN TESTING DISTAL RUN-OFF. VALVE REPLACED. NO DELAYS, ADVERSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314294 HAKIM IN LINE PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CKMBYT

    Patients

    Seq Age Sex Outcome Treatment
    1