BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHILLI CATHETER

    MDR report key: 552689 · Received November 1, 2004

    Report

    Report Number
    2939222-2004-00035
    Event Type
    Death
    Date Received
    November 1, 2004
    Report Date
    October 29, 2004
    Manufacturer
    EP TECHNOLOGIES BSC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A VT ABLATION, THE CATHETER RECORDED ELECTRICAL POTENTIALS FROM THE HEART. HOWEVER, THERE WAS NO ASSOCIATED MECHANICAL MOTION SEEN ON FLUORO (EMD). THE EMD COULD NOT BE RESOLVED AND THE PT EXPIRED ON THE TABLE. DR. DID NOT BELIEVE THAT THE CATHETER WAS THE CAUSE OF THE EMD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILLI CATHETER THERAPEUTIC CATHETER LPB EP TECHNOLOGIES BSC M00442 3005 010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death