BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 1251928 · Received November 19, 2008

    Report

    Report Number
    2183870-2008-00187
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    May 16, 2008
    Report Date
    November 11, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MDR 2183870-2008-00186 FOR THE PROTEGE RX USED IN THIS PROCEDURE.

    Description of Event or Problem · 1

    PT ENROLLED INTO THE TRIAL. TIA REPORTED (NEW NEUROLOGICAL DEFICIT LASTING MORE THAN 10 MINUTES, BUT LESS THAN 24 HOURS). PT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICE NTE EV3 INC. SPD2-US-060-190 5416230

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other