BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEXION

    MDR report key: 3861475 · Received May 21, 2014

    Report

    Report Number
    3861475
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE REFLEXION SPIRAL CATHETER. ONCE DEFLECTED, THE CATHETER WOULD NOT CLOSE PROPERLY WHEN THE PHYSICIAN TRIED CLOSING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303928 REFLEXION CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, INC. * 4033942

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR