BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS SPVB KIT PREATTACHED/BO19-10

    MDR report key: 3005834 · Received February 13, 2013

    Report

    Report Number
    3001587388-2013-00035
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    December 29, 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 LAB ANALYSIS OF THE VALVE WILL BE SENT TO COMPLETE THIS INCIDENT REPORT.

    Description of Event or Problem · 1

    SPVB-2010 WAS IMPLANTED ON (B)(6) BUT IT SEEMED TO BE OCCLUDED ONLY IN 10 DAYS. THEREFORE, THE SURGEON REPLACED THE VALVE ON (B)(6). HE WOULD LIKE TO KNOW WHAT THE CAUSE IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63810 POLARIS SPVB KIT PREATTACHED/BO19-10 POLARIS SPVB KIT PREATTACHED JXG SOPHYSA SA POLARIS Z0243

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK