BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSV II TWO PIECE SYSTEM WITH ANTECHAMBER

    MDR report key: 1140556 · Received August 28, 2008

    Report

    Report Number
    9612007-2008-00024
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    March 30, 2008
    Report Date
    August 28, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE VALVE SYSTEM THAT WAS IMPLANTED WAS NOT FUNCTIONING. IT WAS REMOVED AND ANOTHER VALVE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSV II TWO PIECE SYSTEM WITH ANTECHAMBER CSF FLOW CONTROL VALVES JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention