BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE/5 PRESS.

    MDR report key: 3170730 · Received May 22, 2013

    Report

    Report Number
    3001587388-2013-00096
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    March 16, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE LABORATORY ANALYSIS OF THE VALVE WILL BE SENT TO COMPLETE THIS INCIDENT REPORT.

    Description of Event or Problem · 1

    THE PATIENT WAS MONITORED FOR TWO DAYS AFTER IMPLANTATION BUT HIS CONDITION DID NOT CHANGE. THEREFORE, THE VALVE AND THE DISTAL CATHETER WERE EXTRACTED AND REPLACED. THE SURGEON WOULD LIKE TO KNOW IF THERE IS ANY OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227378 POLARIS ADJUSTABLE VALVE/5 PRESS. POLARIS ADJUSTABLE VALVE/5 PRESS. JXG SOPHYSA SA POLARIS UNK FOR NOW

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR