BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP-4 CLINICAL STIMULATOR

    MDR report key: 1356118 · Received February 26, 2009

    Report

    Report Number
    2248049-2009-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 24, 2009
    Manufacturer
    ST. JUDE MEDICAL - COOPER RUN EXECUTIVE PARK
    Product Code
    JOQ
    PMA / PMN Number
    K040207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). A DISKETTE IS BEING SENT TO THE USER TO OBTAIN A COPY OF THE CASE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE USER REPORTED BEING UNABLE TO STOP PACING STIMULATION DURING THE PROCEDURE. THE EP-4 SYSTEM WAS TURNED OFF IN ORDER TO STOP STIMULATION. THERE WAS NO PATIENT INCIDENT. ON (B) (6) 2009 CONFIRMED: THE DEVICE WAS IDLE AND THE CASE WAS BEING REVIEWED WHEN THE USER REPORTED OBSERVING SIGNALS INDICATING THE HEART WAS BEING PACED, INCLUDING A PACE MAKER. THE USER REPORTED THAT THE UNIT WAS IN F8 PROTOCOL MENU AND CHANGED TO F5 AT SOME POINT IN THE INCIDENT. THE USER TURNED OFF BOTH STIMULATOR CHANNELS. THIS HAD NO EFFECT. SPECIFIED PACING CONTINUED AS DID THE PACE MAKER. THE EP-4 SPEAKER WAS HEARD AS NORMAL WHILE PACING. THE USER TURNED THE SYSTEM OFF TO STOP PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP-4 CLINICAL STIMULATOR DIAGNOSTIC CLINICAL CARDAIC STIMULATOR JOQ ST. JUDE MEDICAL - COOPER RUN EXECUTIVE PARK 09-1527-002

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR