BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS ADJUSTABLE VALVE

    MDR report key: 842876 · Received April 30, 2007

    Report

    Report Number
    3001587388-2007-00124
    Event Type
    Other
    Date Received
    April 30, 2007
    Date of Event
    January 20, 2007
    Report Date
    April 20, 2007
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO MANUFACTURER. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A POLARIS VALVE WAS IMPLANTED IN A PATIENT FOR V-P SHUNTING WITH A SET AT 30MM H2O IN 2006. THE FOLLOWING MONTH, THE SHUNT SYSTEM WAS REMOVED BECAUSE IT SEEMED TO BE OCCLUDED. THE CUSTOMER REQUESTS TO CHECK THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE HYDROCEPHALUS VALVE JXG SOPHYSA SA POLARIS VALVE S0276

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR