BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2355536 · Received December 1, 2011

    Report

    Report Number
    1644487-2011-02878
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 2, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY

    Description of Event or Problem · 1

    FURTHER MANUFACTURER INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE LOW OUTPUT CURRENT RESULT FROM THE DIAGNOSTIC TESTING WAS DUE TO A COMMUNICATION INTERRUPTION THAT OCCURRED DURING THE PROGRAMMING SEQUENCE, PRIOR TO PERFORMING THE DIAGNOSTIC TESTING. BREAKS IN COMMUNICATION BETWEEN THE HANDHELD AND GENERATOR CAN BE CAUSED BY PATIENT MOVEMENT OR RF INTERFERENCE. ANALYSIS OF THE HANDHELD SOFTWARE REVEALED THAT, DUE TO A DESIGN FLAW, IT IS POSSIBLE FOR A COMMUNICATION DISRUPTION TO PREVENT THE SOFTWARE FROM RECEIVING THE FINAL COMMAND IN THE PROGRAMMING SEQUENCE. THOUGH A COMMUNICATION ERROR MESSAGE DOES APPEAR AND SUGGESTS THAT THE USER RE-INTERROGATE THE DEVICE, THE USER HAS THE OPTION TO "CANCEL" THE MESSAGE, AND PROCEED TO PERFORM DIAGNOSTIC TESTING OF THE DEVICE. GIVEN THAT THE GENERATOR DID RECEIVE THE PROGRAMMING COMMAND TO REPROGRAM THE DEVICE TO 0.25MA, BUT THE HANDHELD SOFTWARE DID NOT RECEIVE THE ACKNOWLEDGEMENT BACK THAT THE OUTPUT CURRENT WAS RE-PROGRAMMED, THE SOFTWARE USES THE LAST OUTPUT CURRENT SETTING FROM THE PREVIOUS SUCCESSFUL INTERROGATION. IN THIS CASE, THE GENERATOR WAS PROGRAMMED TO 0MA OUTPUT CURRENT AT THE LAST SUCCESSFUL INTERROGATION. WHEN A SYSTEM DIAGNOSTIC TEST IS SELECTED BY THE USER, THE SOFTWARE IS DESIGNED SUCH THAT IT WILL RUN THE TEST AT 1MA WHEN THE GENERATOR IS PROGRAMMED TO 0MA. ONCE THE TEST IS RUN, AND PRIOR TO DISPLAYING THE RESULTS, THE HANDHELD SOFTWARE WILL COMPARE THE CURRENT DELIVERED TO THE PROGRAMMED OUTPUT CURRENT BOTH OF WHICH ARE INFORMATION STORED WITHIN THE GENERATOR. THE RESULT WILL BE "OK" IF THE PROGRAMMED OUTPUT CURRENT IS 0MA AND THE CURRENT DELIVERED AS MEASURED BY THE GENERATOR IS 1MA. HOWEVER, IF THE PROGRAMMED OUTPUT CURRENT DOES NOT EQUAL 0MA (AS THE HANDHELD SOFTWARE EXPECTS) AND THE OUTPUT CURRENT DELIVERED IS 1MA, THEN THE RESULT WILL BE "LOW". THIS EXPLAINS WHY, WHEN THE MANUFACTURER REPRESENTATIVE USED THEIR HANDHELD AND RE-INTERROGATED THE GENERATOR AND PERFORMED DIAGNOSTIC TESTING, THE RESULTS WERE ALL WITHIN NORMAL LIMITS. GIVEN THAT THE LOW OUTPUT CURRENT DIAGNOSTIC TEST RESULT RESOLVED, THE GENERATOR IS NOT SUSPECTED TO BE ADVERSELY AFFECTED BY THIS ISSUE, AND THE IMPLANTED GENERATOR IS FUNCTIONING AS INTENDED. THIS ISSUE IS RELATED TO THE PROGRAMMING SOFTWARE AND OCCURRED AS A RESULT OF AN ATYPICAL SEQUENCE OF EVENTS THAT FOLLOWED A COMMUNICATION INTERRUPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL IMPLANT LOW OUTPUT CURRENT WAS OBSERVED ON A SYSTEM DIAGNOSTICS TEST. SYSTEMS DIAGNOSTICS WERE PERFORMED OUTSIDE THE PATIENT WITH RESULTS WITHIN NORMAL LIMITS, THE OUTPUT CURRENT WAS DELIVERED AT 1.00 MA AND THE LEAD IMPEDANCE WAS 2188 OHMS. INITIAL REVIEW OF THE PROGRAMMING HISTORY OBTAINED FROM THE DATE OF SURGERY SHOWS THAT THE NEXT OPERATION WAS A PARTIAL PROGRAMMING EVENT. FOLLOWING THE PARTIAL PROGRAMMING EVENT, A SECOND DIAGNOSTIC TEST WAS PERFORMED WITH THE GENERATOR INSIDE THE PATIENT WHICH RESULTED IN: LEAD IMPEDANCE: OK, OUTPUT CURRENT: LOW, CURRENT DELIVERED: 1 MA, IMPEDANCE VALUE: APPROXIMATELY 1300 OHMS. TROUBLESHOOTING STEPS WERE THEN PERFORMED DURING WHICH THE SURGEON IRRIGATED THE NERVE AND TRIED TO MAKE SOME CHANGES TO THE LEAD. SYSTEMS DIAGNOSTICS WERE PERFORMED SEVERAL MORE TIMES WITH THE SAME RESULTS OF LOW OUTPUT CURRENT. GENERATOR DIAGNOSTICS PERFORMED ON THE GENERATOR RESULTED IN APPROXIMATELY 3900 OHMS, WITH OUTPUT CURRENT: OK AND CURRENT DELIVERED: 0.25 MA. THE SURGEON DECIDED TO USE A NEW LEAD. AFTER THE NEW LEAD WAS PLACED AN ADDITIONAL SYSTEMS DIAGNOSTIC TEST WAS PERFORMED. THIS TEST ALSO INDICATED THAT THERE WAS LOW OUTPUT CURRENT. A NEW PROGRAMMING SYSTEM WAS THEN UTILIZED. THE PATIENT'S GENERATOR WAS INTERROGATED AT 0.25 MA, AND DIAGNOSTICS WERE PERFORMED WHICH RESULTED IN A NORMAL IMPEDANCE VALUE OF APPROXIMATELY 1785 OHMS AND OUTPUT CURRENT: OK. THE PATIENT'S GENERATOR WAS THEN PROGRAMMED TO 0.0 MA, AND DIAGNOSTICS WERE AGAIN WITHIN NORMAL LIMITS OF 1668 OHMS WITH OUTPUT CURRENT: OK. THE IMPLANT PROCEDURE WAS THEN COMPLETED. PROGRAMMING HISTORY WAS RECEIVED AND THE LOW OUTPUT CURRENT EVENT, DURING SYSTEM DIAGNOSTICS WAS CONFIRMED. THE DIAGNOSTIC RESULTS REPORTED DURING THE DAY OF THE PROCEDURE WERE ALSO CONFIRMED AND THE EVENT DID RESOLVE PRIOR TO THE COMPLETION OF THE IMPLANT PROCEDURE. THE EXPLANTED LEAD HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER ANALYSIS HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 840143

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR