BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID

    MDR report key: 1220350 · Received November 3, 2008

    Report

    Report Number
    2183870-2008-00161
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    June 18, 2008
    Report Date
    October 16, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MDR 2183870-2008-00162 FOR SPIDERFX USED IN THIS PROCEDURE.

    Description of Event or Problem · 1

    PATIENT ENROLLED INTO THE TRIAL. TIA REPORTED PRE-DISCHARGE, NOT DEVICE RELATED. PATIENT FOUND TO HAVE LEFT ARM WEAKNESS. NO ACTION TAKEN, RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE RX CAROTID NIM NIM EV3 INC. SECX-10-7-40-135 2385492

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other