BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEXION

    MDR report key: 1232383 · Received October 31, 2008

    Report

    Report Number
    1232383
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ST. JUDE MEDICAL
    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 REFLEXION CATHETER HAD NO CURVE WHEN THE DOCTOR MANIPULATED THE HANDLE, MAKING THE DEVICE NON-FUNCTIONAL. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW CATHETER WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEXION CATHETER, EP, STEERABLE DRF ST. JUDE MEDICAL * 2698527

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR