BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO XP SYSTEM

    MDR report key: 955856 · Received November 30, 2007

    Report

    Report Number
    9681484-2007-00202
    Event Type
    Injury
    Date Received
    November 30, 2007
    Date of Event
    November 14, 2007
    Report Date
    November 16, 2007
    Manufacturer
    BIOSENSE WEBSTER, LTD
    Product Code
    DQK
    PMA / PMN Number
    K020863
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K)# IS K042999.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THAT A TAMPONADE HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO XP SYSTEM COMPUTER, DIAGNOSTIC PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD M-4700-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Life Threatening