BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAZER II XP

    MDR report key: 568890 · Received January 28, 2005

    Report

    Report Number
    2939222-2005-00001
    Event Type
    Death
    Date Received
    January 28, 2005
    Date of Event
    October 18, 2004
    Report Date
    January 6, 2005
    Manufacturer
    EP TECHNOLOGIES, BBC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEFT ATRIAL PERFORATION OCCURRED RELATED TO ABLATION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II XP ABLATION CATHETER LPB EP TECHNOLOGIES, BBC. M004 4500THK2 0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death