BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID

    MDR report key: 1251926 · Received November 19, 2008

    Report

    Report Number
    2183870-2008-00182
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    January 31, 2008
    Report Date
    November 11, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT ENROLLED INTO THE TRIAL. ARRHYTHMIA REPORTED WITH BRADYCARDIA AS RELATED TO THE PROTEGE RX STENT. MEDICATION ADMINISTERED AND PT RECOVERED WITH OUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE RX CAROTID NIM NIM EV3 INC. SECX-8-6-40-135 2487668

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other