BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZONTAL/VERTICAL LUMBAR VALVE (50-80, 230-320)

    MDR report key: 561178 · Received May 14, 2004

    Report

    Report Number
    9612007-2004-00039
    Event Type
    Malfunction
    Date Received
    May 14, 2004
    Report Date
    May 14, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE TUBING SPLIT AT THE CONNECTOR PRIOR TO SURGERY. NO PT CONTACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZONTAL/VERTICAL LUMBAR VALVE (50-80, 230-320) DIFFERENTIAL PRESSURE VALVE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * 412356

    Patients

    Seq Age Sex Outcome Treatment
    1 *