BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR THERMOCOOL

    MDR report key: 2062651 · Received April 3, 2011

    Report

    Report Number
    2062651
    Event Type
    Malfunction
    Date Received
    April 3, 2011
    Date of Event
    January 24, 2011
    Report Date
    April 3, 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

    THE MAPPING CATHETER CANNOT ACQUIRE POINTS. HANDED OVER NEW CATHETER AND 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 * 152843544

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR