BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS SPV ADJUSTABLE VALVE / ANTICHAMBER

    MDR report key: 1352772 · Received March 25, 2009

    Report

    Report Number
    3001587388-2009-00057
    Event Type
    Injury
    Date Received
    March 25, 2009
    Date of Event
    February 10, 2009
    Report Date
    March 25, 2009
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENCE HAS BEEN REPORTED TO MANUFACTURER ON MARCH 2009. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A VALVE WAS IMPLANTED IN VENTRICULO-PERITONEAL. AS THE DOCTOR COULDN'T CHANGE THE PRESSURE SETTING OF THE VALVE, THE VALVE WAS EXPLANTED. THE DOCTOR REQUESTED TO CHECK THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS SPV ADJUSTABLE VALVE / ANTICHAMBER HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE 100869

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR