BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 3772215 · Received April 25, 2014

    Report

    Report Number
    1226348-2014-11417
    Event Type
    Injury
    Date Received
    April 25, 2014
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2010, THE DEVICE WAS IMPLANTED VIA L-P SHUNT. SETTING PRESSURE WAS UNKNOWN. AFTER IMPLANTATION, IT WAS NOTED THAT THE VENTRICLES OF THE PATIENT'S BRAIN BECAME LARGE. GAIT DISORDER WAS ALSO NOTED. ON (B)(6) 2012, THE DEVICE WAS REPLACED BY NS9008 DUE TO SUSPECTED VALVE BLOCKAGE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252248 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG PMB408

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention