BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR THERMOCOOL

    MDR report key: 1191643 · Received September 9, 2008

    Report

    Report Number
    1191643
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BIOSENSE
    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 PHYSICIAN PLACED THE NAVISTAR THERMOCOOL INTO THE PATIENT'S BODY, HOWEVER, WHEN CONNECTED, IT DID NOT WORK. THE DEVICE GAVE A SIGNAL, BUT DID NOT PROVIDE NAVIGATION. AFTER TROUBLESHOOTING, THE DEVICE WAS REMOVED AND WAS REPLACED WITH ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION AND THE PATIENT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMOCOOL EP CATHETER "F" TYPE DRF BIOSENSE * 13317184

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR