BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENSITE SYSTEM

    MDR report key: 1155954 · Received September 5, 2008

    Report

    Report Number
    2184149-2008-00011
    Event Type
    Other
    Date Received
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ST. JUDE MEDICAL, ESI
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. A FOLLOWUP MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEERING DEPT CALLED IN 2008 ABOUT SENDING THE ENSITE DISPERSIVE FILTER BACK TO ST. JUDE MEDICAL FOR TESTING. IT WAS REPORTED THAT THE PT RECEIVED A BURN UNDER THE RF RETURN PATCH ON HER LEFT FLANK DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE. THE EXTENT OF THE BURN IS UNK AS WELL AS THE CURRENT CONDITION OF THE PT. THE BIOMEDICAL ENGINEER STATED THAT THEY ARE LOOKING INTO EVERY PIECE OF EQUIPMENT INVOLVED IN THIS INCIDENT, WHICH WOULD INCLUDE THE ST. JUDE MEDICAL DISPERSIVE FILTER AS IT RESIDES IN FRONT OF THE STOCKERT RF GENERATOR ON THE RETURN CIRCUIT FOR THIS UNIPOLAR ABLATION SET UP. THE NAME OF THE ELECTROPHYSIOLOGIST INVOLVED IN THIS CASE IN UNK. NO ADD'L INFO HAS BEEN RECEIVED FROM THE BIOMEDICAL ENGINEERING DEPT AS OF 9/5/2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE SYSTEM ENSITE SYSTEM DRF ST. JUDE MEDICAL, ESI NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other