BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELSIUS DS

    MDR report key: 623066 · Received July 18, 2005

    Report

    Report Number
    623066
    Event Type
    Other
    Date Received
    July 18, 2005
    Date of Event
    July 13, 2005
    Report Date
    July 18, 2005
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS PLACED IN THE PATIENT FOR LESS THAN ONE MINUTE WHEN IT WAS NOTED THAT THE CURVE WAS BAD. THIS CATHETER WAS REMOVED IMMEDIATELY AND SUBSTITUTED WITH A NEW ONE, WHICH WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELSIUS DS ELECTROPHYSIOLOGY CATHETER DRF BIOSENSE WEBSTER * 13035325

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR