BEUDAMED
    FDA Adverse Event Death Summary report: N

    HV LUMBAR VALVE SYSTEM

    MDR report key: 357309 · Received October 25, 2001

    Report

    Report Number
    9612007-2001-00026
    Event Type
    Death
    Date Received
    October 25, 2001
    Date of Event
    September 12, 2001
    Report Date
    September 26, 2001
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT A PT WHO HAD BEEN PREVIOUSLY DIAGNOSED WITH PSEUDO TUMOR CEREBRI HAD THE VALVE IMPLANTED IN 2001. SIX WEEKS LATER, THE PT WAS ADMITTED TO THE HOSP WITH SEVERE HEADACHE, AND A SCAN INDICATED THAT THE PT WAS SUFFERING HYDROMYELIA AND A HERNIATION OF THE BRAIN STEM THROUGH THE FORAMEN MAGNUM. THE PT DIED LATER THAT EVENING. THE VALVE WAS EXPLANTED 2 DAYS FOLLOWING THE PT'S DEATH. INITIAL INSPECTION OF THE VALVE BY THE DOCTOR SHOWED NO OBSTRUCTION OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47928 HV LUMBAR VALVE SYSTEM HYDROCEPHALUS VALVE JXG NMT NEUROSCIENCES IMPLANTS S.A. NA 20199035

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Death