BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE/5 PRESS

    MDR report key: 3723832 · Received May 22, 2013

    Report

    Report Number
    3001587388-2013-00093
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    March 6, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Adverse Event
    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 SURGEON FIXED THE PRESSURE SETTING TO 200MMH20 BUT THE PT SUFFERED FROM THE SLIT VENTRICLE SYNDROME. SINCE HE THOUGHT THE VALVE MIGHT BE MALFUNCTIONING, HE EXTRACTED IT. PLEASE EXAMINE THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228206 POLARIS ADJUSTABLE VALVE/5 PRESS POLARIS ADJUSTABLE VALVE/5 PRESS JXG SOPHYSA SA POLARIS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR