BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2862549 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03258
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIPTION OF EVENT, CORRECTED DATA: INFORMATION INADVERTENTLY NOT INCLUDED IN INITIAL MDR. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PHYSICIAN STATED THAT EARLIER THAT DAY HE TRIED TO PERFORM A CHECK-UP FOR THE PATIENT AND RECEIVED A 'FAILURE TO RECEIVE MODEL AND SERIAL NUMBER FROM GENERATOR' ERROR. THE PATIENT WAS UNABLE TO BE INTERROGATED; HOWEVER, THE PHYSICIAN STATED HE WAS NOT CONCERNED AND WOULD HAVE THE PATIENT COME BACK TO GET RE-INTERROGATED AFTER THE ISSUE WAS RESOLVED. THE PHYSICIAN CONFIRMED THAT HE WAS CERTAIN THERE WERE NO ISSUES WITH THE PATIENT'S GENERATOR AS THE PATIENT WAS IMPLANTED ONLY TWO YEARS PRIOR AND NO BATTERY DEPLETIONS FLAGS HAD BEEN VISUALIZED AT THE LAST APPOINTMENT A MONTH AGO. TROUBLESHOOTING STEPS WERE TAKEN TO TRY TO RESOLVE THE ISSUE. THE WAND BATTERY WAS REPLACED, THE HANDHELD WAS UNPLUGGED FROM THE WALL, AND NO ELECTRO-MAGNETIC INTERFERENCE WAS IN THE ROOM. THE ISSUE WAS NARROWED DOWN TO THE SERIAL CABLE, AS THE PHYSICIAN'S HANDHELD AND WAND WERE INTERROGATING SUCCESSFULLY WHEN PAIRED WITH A WORKING SERIAL CABLE. THE SERIAL CABLE WAS REPLACED AND IS PENDING RETURN TO THE COMPANY FOR PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    THE SERIAL CABLE WAS RETURNED ON (B)(4) 2013. PRODUCT ANALYSIS FOUND NO ANOMALIES ASSOCIATED WITH THE SERIAL CABLE DURING TESTING. THE SERIAL CABLE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE FOLLOWING STEPS WERE PERFORMED FOR FUNCTIONAL ANALYSIS OF THE SERIAL CABLE: A KNOWN GOOD HANDHELD DEVICE WAS POWERED USING A KNOWN GOOD AC ADAPTER AND RETURNED SERIAL CABLE. PERFORMED THE INITIAL SETUP PROCESS INCLUDING THE SCREEN ALIGNMENT WITH NO OBSERVED ANOMALIES. MOVED AND TWISTED THE AC ADAPTER POWER CONNECTOR ON THE SERIAL CABLE WITH NO OBSERVED ANOMALIES. INTERROGATION AND DIAGNOSTIC TESTS WERE PERFORMED SUCCESSFULLY WITH NO OBSERVED ANOMALIES USING V8.0 SOFTWARE. THE HANDHELD MAIN BATTERY WAS FULLY CHARGED. INTERROGATION AND DIAGNOSTIC TESTS WERE SUCCESSFULLY PERFORMED USING MAIN BATTERY POWER. THE FOLLOWING STEPS WERE PERFORMED SUCCESSFULLY 5 TIMES WITH NO OBSERVED ANOMALIES: INTERROGATED GENERATOR. PROGRAMMED OUTPUT AND MAGNET CURRENTS FROM 0MA TO 0.5MA. INTERROGATED GENERATOR TO VERIFY NEW SETTINGS. PERFORMED GENERATOR DIAGNOSTIC TEST, GENERATOR VALUES WERE CHANGED BACK TO OUTPUT CURRENTS OF 0MA. INTERROGATED GENERATOR TO VERIFY NEW SETTINGS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    AMONG THE REASONS WHY THE PHYSICIAN BELIEVED THE COMMUNICATION ISSUE WAS NOT DUE TO THE PATIENT'S GENERATOR, IT WAS ADDITIONALLY NOTED THAT THE PATIENT COULD FEEL STIMULATION, INDICATING THE PATIENT'S DEVICE WAS FUNCTIONING.

    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 44 YR