BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION

    MDR report key: 4201996 · Received August 28, 2014

    Report

    Report Number
    4201996
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BOSTON RESOLUTION CLIP FAILED TO DEPLOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526361 RESOLUTION CLIP, IMPLANTABLE MND BOSTON SCIENTIFIC CORP. * ML000794C3

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR