BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS SPVA KIT PREATTACHED / BO19-10

    MDR report key: 1614535 · Received February 10, 2010

    Report

    Report Number
    3001587388-2009-00350
    Event Type
    Injury
    Date Received
    February 10, 2010
    Date of Event
    November 1, 2009
    Report Date
    December 24, 2009
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE SHOULD BE ANALYZED.

    Description of Event or Problem · 1

    A FEW DAYS AFTER THE IMPLANTATION OF A POLARIS VALVE, THE PATIENT SUFFERED OF OVERDRAINAGE, THOUGH THE VALVE WAS AT THE POSITION NUMBER 5 AT 200MM H2O. AS THE PATIENT'S HEALTH WAS NOT IMPROVED, 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 SPVA KIT PREATTACHED / BO19-10 HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE W0016

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR