BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFEXION BI-DIRECTIONAL DECAPOLAR

    MDR report key: 2131363 · Received June 14, 2011

    Report

    Report Number
    2131363
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE CATHETER DID NOT SHOW ALL POLES ON THE 3D ENSITE (ESI) MAPPING EQUIPMENT. THERE WAS ARTIFACT ON THE ELECTROGRAMS AND THEY WOULD NOT MATCH UP ON THE SCREEN. A NEW CATHETER WAS USED, PROCEDURE WAS SUCCESSFUL AND PATIENT RECOVERED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFEXION BI-DIRECTIONAL DECAPOLAR CATHETER, MAPPING, CARDIAC DRF ST. JUDE MEDICAL * 3328191

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR NO OTHER THERAPIES