BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP-4 STIMULATOR, 2 CHANNEL

    MDR report key: 2438237 · Received January 12, 2012

    Report

    Report Number
    2184149-2012-00003
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    December 23, 2011
    Report Date
    December 23, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    JOQ
    PMA / PMN Number
    K092913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: IMPEDANCE TESTING, POWER SOURCE TESTING. SIMULATED USE TESTING, PROCESS EVALUATION. VISUAL INSPECTION OF THE RETURNED EP-4 STIMULATOR REVEALED NO ANOMALIES. DURING FUNCTIONAL TESTING, THE EP-4 STIMULATOR PASSED THE POST (POWER ON SELF-TEST) AND COMMUNICATED WITH THE TOUCHSCREEN PC SUCCESSFULLY. THE SELF-TEST AND PRELIMINARY TESTS WERE PERFORMED PER THE SYSTEM MANUAL. SERIAL COMMUNICATION FUNCTIONED PROPERLY BETWEEN THE EP-4 STIMULATOR, TOUCHSCREEN PC AND EP WORKMATE SYSTEM. EMERGENCY STIMULATION WAS ALSO TESTED AND FOUND TO BE FUNCTIONING AS EXPECTED. THE ADJUSTABLE AUDIBLE TONE FUNCTIONED AS DESIGNED. OUTPUT AMPLITUDE AND IMPEDANCE TESTS WERE PERFORMED. THE STIMULUS OUTPUTS MEASURED WITHIN THE ACCEPTANCE CRITERIA. A PACING TEST WAS PERFORMED WITH THE WORKMATE SYSTEM AND THE STIMULUS OUTPUTS MEASURED WITHIN THE ACCEPTANCE CRITERIA. A PACING TEST WAS PERFORMED WITH THE WORKMATE SYSTEM AND RECORDED DATA WAS REVIEWED. THE UNIT PRODUCED THE CORRECT PACING PARAMETERS (AMPLITUDES, PULSE-WIDTHS, AND SEQUENTIAL TIMING). THE EP-4 STIMULATOR WAS ALLOWED TO RUN-IN WITH THE F8 (ARRHYTHMIA INDUCTION) PROTOCOL FOR AN ADD'L 24 HOURS WITHOUT ERRORS OR BOARD RESETS RECORDED. FUNCTIONAL TESTING INDICATED THE EP-4 STIMULATOR FUNCTIONED AS DESIGNED. VISUAL INSPECTION OF THE RETURNED EP-4 TOUCHSCREEN REVEALED A LOOSE FRONT BEZEL AND A MISSING I/O COVER. NO OTHER ANOMALIES WERE NOTED. DURING FUNCTIONAL TESTING, AC POWER WAS APPLIED TO THE TOUCHSCREEN PC AND THE POWER ON SELF TEST (POST) WAS OBSERVED. THE TOUCHSCREEN PC PRODUCED ONE AUDIBLE BEEP AS AN INDICATION OF A SUCCESSFUL POST AND SUCCESSFUL ATTEMPTS TO LOAD THE OS (OPERATING SYSTEM) AND EP-4 APPLICATION. THE TOUCHSCREEN PC FULLY BOOTED AND INITIATED COMMUNICATION WITH THE EP-4 STIMULATOR SUCCESSFULLY. WINDOWS EVENT LOGS WERE REVIEWED AND CONFIRMED THE TOUCHSCREEN PC FUNCTIONED NORMALLY. THE UNIT COMMUNICATED SIMULTANEOUSLY WITH THE EP-4 STIMULATOR AND THE EP WORKMATE SYSTEM. A COMMUNICATION TEST WAS PERFORMED WITH HYPER TERMINALS AND VERIFIED BOTH COM1 AND COM2 DID NOT EXHIBIT DELAY OR ERRORS DURING THE COMMUNICATION TEST. THE SYSTEM SUITE DIAGNOSTICS "STRESS TEST" ALSO CONFIRMED THE TOUCHSCREEN PC PASSED ALL TESTING REQUIRED. THE TOUCHSCREEN PC WAS CONNECTED TO THE EP-4 STIMULATOR AND WORKMATE SYSTEM AND DURING THE TEST RUN-IN FOR APPROX 24 HOURS WITHOUT UNEXPECTED ERROR RECORDED. TESTING INDICATED THE TOUCHSCREEN PC FUNCTIONED AS EXPECTED. ADD'L ANALYSIS OF THE REPORTED EVENT IS BEING CONDUCTED. IF ADD'L RELEVANT INFO BECOMES AVAILABLE. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EP4 STIMULATOR WAS DELIVERING STIMULATION INCORRECTLY ON THE F8 PROTOCOL. THERE WAS NO HARM TO THE PT AND THE CASE WAS ABLE TO BE FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP-4 STIMULATOR, 2 CHANNEL COMPUTERIZED STIMULATOR JOQ ST. JUDE MEDICAL, AF DIVISION 09-1527-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR EP-4 TOUCHSCREEN, 09-1694-1002, SN IS (B)(4)