BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 389827 · Received April 25, 2002

    Report

    Report Number
    9612007-2002-00005
    Event Type
    Injury
    Date Received
    April 25, 2002
    Date of Event
    March 20, 2002
    Report Date
    April 19, 2002
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT A VALVE SYSTEM WAS IMPLANTED IN 2001 IN A PATIENT. SURGEON HAD TO REMOVE THIS VALVE IN 2002, BECAUSE CEREBRAL PRESSURE WAS TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VALVE HYDROCEPHALUS VALVE JXG NMT NEUROSCIENCES IMPLANTS S.A. NA 112342

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention