BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE/5 PRESS

    MDR report key: 3005835 · Received February 13, 2013

    Report

    Report Number
    3001587388-2013-00034
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 5, 2013
    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 VALVE HAS NOT BEEN RETURNED YET. THE RESULTS OF THE LABORATORY ANALYSIS OF THE VALVE WILL BE SENT TO COMPLETE THIS INCIDENT REPORT.

    Description of Event or Problem · 1

    THIS PATIENT SUFFERS FROM CHRONIC SUBDURAL HEMATOMA. SPV WAS IMPLANTED ON (B)(6) BUT IT SOON SEEMED TO BE OCCLUDED. THEREFORE, THE SURGEON REPLACED THE VALVE ON 9 OF JANUARY. HE WOULD LIKE TO KNOW IF IT IS REALLY OCCLUDED AND WHAT THE ROOT CAUSE IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63172 POLARIS ADJUSTABLE VALVE/5 PRESS POLARIS ADJUSTABLE VALVE/5 JXG SOPHYSA SA POLARIS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK