BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEXION STEERABLE CATHETER

    MDR report key: 1232344 · Received October 29, 2008

    Report

    Report Number
    1232344
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    August 25, 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 ELECTROPHYSIOLOGY CATHETER WOULD NOT COMPLETE THE CURVE INSIDE OR OUTSIDE THE PATIENT'S BODY, DESPITE SEVERAL EFFORTS BY THE DOCTOR AND NURSE. THE DEVICE WAS REPLACED BY A NEW DEVICE WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEXION STEERABLE CATHETER CATHETER, EP, STEERABLE DRF ST. JUDE MEDICAL, INC. * 2683920

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR