BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS ADJUSTABLE PRESSURE VALVE

    MDR report key: 842968 · Received April 23, 2007

    Report

    Report Number
    3001587388-2007-00106
    Event Type
    Other
    Date Received
    April 23, 2007
    Date of Event
    January 31, 2007
    Report Date
    April 18, 2007
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO MANUFACTURER ON 03/28/2007. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A POLARIS ADJUSTED PRESSURE VALVE WAS IMPLANTED IN A PATIENT IN 2007. THOUGH MORE THAN 2 WEEKS PASSED, THE PATIENT'S CONDITION WAS NOT IMPROVED. (SHRINKING OF CEREBRAL VENTRICLES WAS NOT OBSERVED, FOR EXAMPLE). THE CUSTOMER REQUEST TO CHECK THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE PRESSURE VALVE HYDROCEPHALUS VALVE JXG SOPHYSA SA POLARIS (R) VALVE S0131

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR