BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSTELLATION ADVANCED MAPPING CATHETER

    MDR report key: 514409 · Received March 4, 2004

    Report

    Report Number
    2939222-2004-00006
    Event Type
    Death
    Date Received
    March 4, 2004
    Date of Event
    December 19, 2003
    Report Date
    February 3, 2004
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    MTD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT'S PACEMAKER WAS TURNED OFF FOR A PULMONARY VEIN ABLATION PROCEDRE AND WAS NOT SUBSEQUENTLY RE-ACTIVATED. FORTY-FIVE MINUTES AFTER ISOLATING THE LEFT VEINS, THE PT EXPERIENCED A MASSIVE PERICARDIAL EFFUSION AND SUBSEQUENTLY EXPIRED. THE CONSTELLATION CATHETER WAS USED AS A DIAGNOSTIC TOOL AND THE BLAZER II CATHETER WAS USED FOR RF ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION ADVANCED MAPPING CATHETER ADVANCED DIAGNOSTIC MAPPING CATHETER MTD EP TECHNOLOGIES, INC. 8031 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death BLAZER II RF ABLATION CATHETER, 2003.