BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER CARTO XP

    MDR report key: 738364 · Received June 30, 2006

    Report

    Report Number
    9681484-2006-00042
    Event Type
    Malfunction
    Date Received
    June 30, 2006
    Date of Event
    June 23, 2006
    Report Date
    June 30, 2006
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DQK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    MAP SHIFT DURING AFIB PROCEDURE, WITH NO ERROR CODE FOR THE MAP SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CARTO XP NAVIGATION SYSTEM DQK BIOSENSE WEBSTER CARTO XP 4263

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other