BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEXION STEERABLE CATHETER

    MDR report key: 1232384 · Received October 29, 2008

    Report

    Report Number
    1232384
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ST. JUDE MEDICAL, INC.
    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 DOCTOR ATTEMPTED TO USE THE REFLEXION CATHETER BUT IT WOULD NOT CURVE AS DESIGNED EITHER INSIDE OR OUTSIDE THE PATIENT'S BODY. THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY AND REPLACED WITH ANOTHER REFLEXION CATHETER WHICH FUNCTIONED APPROPRIATELY. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEXION STEERABLE CATHETER CATHETER, EP, STEERABLE DRF ST. JUDE MEDICAL, INC. * 2694775

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR