BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-V LUMBAR VALVE SYSTEM

    MDR report key: 200482 · Received December 2, 1998

    Report

    Report Number
    9612007-1998-00020
    Event Type
    Injury
    Date Received
    December 2, 1998
    Date of Event
    June 21, 1998
    Report Date
    December 2, 1998
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS SA
    Product Code
    JXG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED IN A PATIENT WITH AN ARACHNOID CYST ON MAY 21, 1998. A SUBCUTANEOUS EDEMA LED TO THE DEVICE EXPLANTATION ON JUNE 21, 1998. THE USER COMPLAINED THAT THE VALVE BASAL SUTURE HOLE WAS TORN AND THE CONNECTION BETWEEN THE VALVE AND LUMBAR CATHETER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-V LUMBAR VALVE SYSTEM Implant HYDROCEPHALUS VALVE JXG NMT NEUROSCIENCES IMPLANTS SA NA 21097163

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention