BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 380994 · Received March 13, 2002

    Report

    Report Number
    9612007-2002-00002
    Event Type
    Injury
    Date Received
    March 13, 2002
    Date of Event
    February 8, 2002
    Report Date
    February 19, 2002
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DEVICE IN CASE WAS IMPLANTED IN 2002. SURGEON HAD TO REMOVE THIS VALVE THE NEXT DAY, BECAUSE THE VALVE "TELESCOPED" DOWN THE CATHETER AND OCCLUDED THE FLOW OF CEREBRO-SPINAL FLUID. PATIENT CONDITION WAS REPORTED AS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VALVE HYDROCEPHALUS VALVE JXG NMT NEUROSCIENCES IMPLANTS S.A. NA 104878

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention