BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HV LUMBAR VALVE SYSTEMS

    MDR report key: 398789 · Received June 11, 2002

    Report

    Report Number
    9612007-2002-00008
    Event Type
    Injury
    Date Received
    June 11, 2002
    Report Date
    May 15, 2002
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR HAS A PT WITH PSEUDOTUMOR IN WHICH HE BELIEVES THAT THERE IS AN INTERMITTENT OBSTRUCTION WHICH HE BELIEVES IS DUE TO AN INTERMITTENT KINK (THIS IS UNCONFIRMED). THIS SYSTEM NEEDS TO BE REVISED. WHEN THE SHUNT IS TAPPED, HE HAS MEASURED LUMBAR PRESSURES AS HIGH AS 230 MMH20 WHICH HE INDICATED INDICATES AN OBSTRUCTION. HE BELIEVES THE PERITONEAL SIDE MAY BE KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HV LUMBAR VALVE SYSTEMS HYDROCEPHALUS VALVE JXG NMT NEUROSCIENCES IMPLANTS S.A. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention