BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY MINI ADJUSTED VALVE/8 PRESSURE

    MDR report key: 972199 · Received December 21, 2007

    Report

    Report Number
    3001587388-2007-00419
    Event Type
    Other
    Date Received
    December 21, 2007
    Date of Event
    November 13, 2007
    Report Date
    December 20, 2007
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO MFR ON 12/11/2007. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED IN VENTRICULO-PERITONEAL IN THE PT IN 2007. IN TWO MONTHS LATER, FUNCTION OF THE SHUNT GOT WORSE. THE VALVE WAS REMOVED. THE DOCTOR REQUEST TO CHECK THE VALVE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY MINI ADJUSTED VALVE/8 PRESSURE HYDROCEPHALUS VALVE JXG SOPHYSA SA SOPHY VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR