BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE (SPV)

    MDR report key: 1358195 · Received April 6, 2009

    Report

    Report Number
    3001587388-2009-00088
    Event Type
    Injury
    Date Received
    April 6, 2009
    Date of Event
    March 26, 2008
    Report Date
    April 6, 2009
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT HAS BEEN REPORTED TO MANUFACTURER ON 04/03/2009. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED IN VENTRICULO-PERITONEAL. THE DOCTOR COULDN'T CHANGE THE PRESSURE SETTING OF THE VALVE. HE TRIED UNDER X-RAY BUT HE FAILED. THE VALVE WAS EXPLANTED. THE DOCTOR HAS REQUESTED TO CHECK THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE (SPV) HYDROCEPHALUS VALVE JXG SOPHYSA SA POLARIS VALVE AT RECEPTION OF THE PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK