BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 400320 · Received June 20, 2002

    Report

    Report Number
    9612007-2002-00010
    Event Type
    Injury
    Date Received
    June 20, 2002
    Report Date
    May 24, 2002
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT DURING A SURGICAL HYDROCEPHALUS VALVE REVISION, THE CONNECTION BETWEEN THE CAP BURR HOLE AND THE VALVE WAS FOUND BROKEN. PATIENT WAS REPORTED TO HAVE BEEN OPERATED IN 2002 AND TO HAVE DIED 13 DAYS LATER. THIS DEATH WAS NOT REPORTED AS RELATED TO THE DEVICE FAILURE, HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VALVE HYDROCEPHALUS VALVE JXG NMT NEUROSCIENCES IMPLANTS S.A. NA 111166

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention