BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR EP-3 INTEGRATED

    MDR report key: 1895339 · Received November 2, 2010

    Report

    Report Number
    2184149-2010-00035
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    JOQ
    PMA / PMN Number
    K092913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND FUNCTIONAL TESTING OF THE RETURNED UNIT REVEALED NO ANOMALIES. THE MINIMUM INTERSTIMULUS INTERVAL IN S1 IS 100MS. AN INVALID ENTRY OF THE F5 PROTOCOL FOR S1 PACING CYCLE LENGTH RESULTS IN THE PARAMETER DEFAULTING TO 100MS. INVALID ENTRY, WHICH INCLUDES MISSING A KEYSTROKE OF PRESSING THE RETURN KEY WITH ONLY 2 DIGITS IN THE CYCLE LENGTH BOX, WILL RESULT IN A DEFAULT SETTINGS OF 100MS AS THIS IS THE LOWEST ACCEPTABLE CYCLE LENGTH IN THIS PROTOCOL. INVESTIGATION REVEALED THE REPORTED EVENT WAS MOST LIKELY CAUSED BY A USER SET UP ERROR IN ENTERING CYCLE LENGTH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A EP PROCEDURE USING THE EP3 STIMULATOR, THE USER WAS PACING IN THE F5 PROTOCOL AT 450MSEC. THE USER STOPPED PACING AND THEN STARTED AGAIN AND THE UNIT CHANGED FROM 450MSEC TO 100 MSEC. THIS CAUSED THE PT TO GO INTO ATRIAL FIBRILLATION. THE PT WAS CARDIOVERTED AND REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULATOR EP-3 INTEGRATED NONE JOQ ST. JUDE MEDICAL, AF DIVISION 78-0002-0000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other