BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS SPV ADJUSTABLE VALVE/BURR HOLE

    MDR report key: 3005851 · Received February 13, 2013

    Report

    Report Number
    3001587388-2013-00019
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    December 25, 2012
    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

    BEFORE IMPLANTATION, THE SURGEON PERFORMED A PATENCY TEST BUT WATER DID NOT GO THROUGH INSIDE THE SHUNT SYSTEM. HE USED ANOTHER STOCK ITEM INSTEAD. HE WOULD LIKE TO KNOW IF IT IS OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63932 POLARIS SPV ADJUSTABLE VALVE/BURR HOLE POLARIS SPV ADJUSTABLE VALVE JXG SOPHYSA SA POLARIS Y0438

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK