BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR THERMOCOOL

    MDR report key: 2240807 · Received August 28, 2011

    Report

    Report Number
    2240807
    Event Type
    Malfunction
    Date Received
    August 28, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 28, 2011
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS NOISE ON INTRACARDIAC SIGNALS WHEN ABLATING WITH CATHETER. HANDED OVER A NEW CATHETER AND THE PROBLEM WAS RESOLVED. NO HARM CAME TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMOCOOL CATHETER, ABLATION, RF, CARDIAC OAD BIOSENSE WEBSTER * 15390487M

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR