BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV

    MDR report key: 1905826 · Received October 2, 2010

    Report

    Report Number
    1905826
    Event Type
    Malfunction
    Date Received
    October 2, 2010
    Date of Event
    August 12, 2010
    Report Date
    October 2, 2010
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER HAD INACCURATE READINGS ON POLE #20. IT WAS REPLACED SUCCESSFULLY WITH A NEW CATHETER. THIS IS NOT OUT-OF-BOX FAILURE, FAILED DURING PROCEDURE, UNKNOWN AT WHAT POINT IN PROCEDURE. NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 NAV CATHETER, MAPPING DRF BIOSENSE WEBSTER NA 15143181

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR