BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC COMPLETE SE BILIARY

    MDR report key: 1667684 · Received April 21, 2010

    Report

    Report Number
    MW5015659
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 21, 2010
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP ON DEPLOYMENT DEVICE FOR STENT BROKE OFF IN VESSEL. PHYSICIAN UNABLE TO RETRIEVE TIP, LEFT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC COMPLETE SE BILIARY COMPLETE SE BILIARY STENT FGE MEDTRONIC VASCULAR SC620L 6MM X 20MM 0000787784

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR