BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE

    MDR report key: 1657324 · Received March 30, 2010

    Report

    Report Number
    3001587388-2010-00097
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 30, 2010
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO MFR ON 03/10/2010. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A F/U REPORT.

    Description of Event or Problem · 1

    THEY COULD NOT CHANGE THE PRESSURE SETTING EVEN UNDER X-RAY. THEY REPLACED THE VALVE AND WOULD LIKE TO KNOW THE ROOT CAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE V0272

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR