BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 725429 · Received June 6, 2006

    Report

    Report Number
    3001587388-2006-00011
    Event Type
    Other
    Date Received
    June 6, 2006
    Date of Event
    March 15, 2006
    Report Date
    May 24, 2006
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS VALVE WAS IMPLANTED IN A PT FOR V-P SHUNTING (IMPLANTATION DATE UNK). AS THE VALVE SEEMED TO BE OCCLUDED, NEUROSURGEON REMOVED IT AND REVISED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA POLARIS (R) VALVE P0377

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other