BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVEWIRE STEERABLE DUO-DECA

    MDR report key: 2182173 · Received July 5, 2011

    Report

    Report Number
    2182173
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 16, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE LIVEWIRE CATHETER WAS INSERTED TO BODY VIA SHEATH AND PLACED IN PROPER POSITION. THE CABLES WERE THEN ATTACHED AND WE COULD NOT OBTAIN AN INTRACARDIAC READING FOR ALL POLES OF THE CATHETER, SPECIFICALLY POLE 3 AND 4 AND POLE 13 AND 14. THE LIVEWIRE CATHETER WAS REMOVED FROM THE PATIENT AND A NEW ONE WAS OBTAINED SHOWING ALL INTRACARDIAC READINGS. LIVEWIRE WILL BE SENT BACK TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVEWIRE STEERABLE DUO-DECA CATHETER, DIAGNOSTIC, CARDIAC DRF ST. JUDE MEDICAL * 3351845

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR