BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP XT CATHETER

    MDR report key: 93598 · Received May 22, 1997

    Report

    Report Number
    1217435-1997-00163
    Event Type
    Malfunction
    Date Received
    May 22, 1997
    Date of Event
    April 18, 1997
    Report Date
    April 22, 1997
    Manufacturer
    USCI DIV C.R. BARD, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ELECTROPHYSIOLOGY PROCEDURE THIS DEVICE WOULD NOT SENSE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP XT CATHETER ELECTRODE CATHETER DYG USCI DIV C.R. BARD, INC. NA 08KG2254

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN