BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE

    MDR report key: 1657327 · Received March 30, 2010

    Report

    Report Number
    3001587388-2010-00063
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    February 12, 2010
    Report Date
    March 29, 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 02/2010. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A F/U REPORT.

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED LAST NOVEMBER. HOWEVER, THE PT SUFFERED FROM DISTURBANCE OF CONSCIOUSNESS ON FEB 6TH. THE DOCTOR FOUND THE VENTRICULAR ENLARGEMENT LATER. THE DOCTOR WANTS TO KNOW THE REASON OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE W0071

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR