BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3030318 · Received April 2, 2013

    Report

    Report Number
    1644487-2013-00881
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. REVIEW OF THE GENERATOR SOURCE CODE INDICATES FLUCTUATING IMPEDANCE IN THE SYSTEM IS NOT LIKELY A CAUSE OF THE PULSE GENERATOR'S INABILITY TO DELIVER THE HIGHER PROGRAMMED OUTPUT CURRENT SETTING.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT SYSTEM DIAGNOSTIC RESULTS SHOWED LOW OUTPUT. LEAD IMPEDANCE WAS OKAY. THE DEVICE WAS INTERROGATED AT 2.75MA/20HZ/130USEC/14SEC/5MIN; 3.0MA/130USEC/60SEC AND THEN THE DEVICE WAS PROGRAMMED UP TO 3.0MA/3.5MA. A SYSTEMS DIAGNOSTIC TEST WAS PERFORMED WHICH RESULTED IN COMMUNICATION: OK / OUTPUT CURRENT: LOW / OUTPUT CURRENT: 2.75MA / LEAD IMPEDANCE: 3493OHMS / IFI: NO (DIAGNOSTICS WERE NOT PERFORMED PRIOR TO THE INCREASE IN SETTINGS). THE PATIENT WAS LAST SEEN ON (B)(6) 2013, AND NO PROGRAMMING CHANGES WERE MADE. PREVIOUSLY, ON (B)(6) 2013, THE OUTPUT CURRENT WAS INCREASED UP BY 0.25MA. REVIEW OF THE GENERATOR SOURCE CODE INDICATES FLUCTUATING IMPEDANCE IN THE SYSTEM IS NOT LIKELY A CAUSE OF THE PULSE GENERATOR'S INABILITY TO DELIVER THE HIGHER PROGRAMMED OUTPUT CURRENT SETTING. THE DATA INDICATES THAT THE GENERATOR APPEARS TO BE CONSISTENTLY DELIVERING A CERTAIN AMOUNT OF OUTPUT CURRENT. THE GENERATOR REMAINS IMPLANTED IN THE PATIENT, AND NO PATIENT ADVERSE EVENTS HAVE BEEN REPORTED. REVIEW OF MANUFACTURING RECORDS FOR THE GENERATOR CONFIRMED THE GENERATOR MET ALL FINAL ELECTRICAL TESTING REQUIREMENTS. HOWEVER, AS THE GENERATOR REMAINS IMPLANTED IN THE PATIENT THE DEVICE IS NOT ABLE TO BE FURTHER EVALUATED, AND THE EXACT CAUSE IS NOT KNOWN. INVESTIGATION SHOWED THAT THERE WERE NO PRODUCT OR SYSTEM ISSUES BELIEVED TO HAVE CAUSED THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134549 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3036

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR