BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-WORKMATE

    MDR report key: 3763290 · Received April 4, 2014

    Report

    Report Number
    2184149-2014-00003
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-ST. PAUL)
    Product Code
    JOQ
    PMA / PMN Number
    K092913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING AN EP-4 CARDIAC STIMULATOR, THE PATIENT DEVELOPED PHRENIC NERVE PALSY. THE PROCEDURE WAS INITIATED USING ENSITE NAVX FOR MAPPING AND THE PHRENIC NERVE WAS REPORTEDLY LOCATED BY PACING ON THE RIGHT SIDE OF THE HEART. THE PHYSICIAN THEN CHANGED TO USING ENSITE ARRAY FOR MAPPING. RADIOFREQUENCY ABLATION WAS BEING PERFORMED IN THE RIGHT ATRIUM WHEN THE PATIENT'S DIAPHRAGM MOVEMENT WAS NOTED TO BE DECREASED. AFTER APPROXIMATELY 20 MINUTES, THE PATIENT APPEARED TO RECOVER AND THE PHYSICIAN CHANGED BACK TO USING ENSITE NAVX WHERE CAPTURE OF CARDIAC TISSUE AND THE PHRENIC NERVE WAS UNSUCCESSFUL. IT WAS THEN NOTED TWO PACING CHANNELS WERE SELECTED ON THE EP-4 CARDIAC STIMULATOR, INSTEAD OF ONE. WHEN ONE CHANNEL WAS DESELECTED, PACING WAS THEN SUCCESSFUL. TWO DAYS LATER, THE PATIENT COMPLAINED OF DIFFICULTY TAKING A FULL BREATH. A CT OF THE CHEST REVEALED THE RIGHT HEMIDIAPHRAGM WAS ELEVATED AND NOT RESPONDING SMOOTHLY. THE PATIENT IS CURRENTLY RECEIVING PULMONARY REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203775 EP-WORKMATE JOQ ST. JUDE MEDICAL, INC. (AF-ST. PAUL) WM-01M-1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ENSITE ARRAY CATHETER