BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1123811 · Received August 15, 2008

    Report

    Report Number
    1644487-2008-01923
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    February 18, 2008
    Report Date
    August 7, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE GENERATOR WAS EXPLANTED DUE TO END OF SERVICE AND RETURNED TO MANUFACTURER FOR ANALYSIS. ANALYSIS CONFIRMED THE END OF SERVICE CONDITION. ADDITIONALLY DURING THE ANALYSIS, THE R35 RESISTOR WAS FOUND TO BE OUT OF SPECIFICATION. THE CAGED MODULE WAS FOUND TO EXHIBIT AN OUT -OF-LIMIT (HIGH) PULSING CURRENT. ANALYSIS INDICATES THAT DURING MANUFACTURING OF THE GENERATOR, THE R35 RESISTOR (A SELECTABLE VALUE RESISTOR) COULD HAVE BEEN MORE OPTIMALLY CHOSEN. A LOWER VALUE RESISTOR WOULD HAVE MORE SUITABLY CENTERED THE CURRENTS WITHIN THEIR LIMITS. USING THE LOWER VALUE, THE CAGED MODULE MET ALL TEST SPECIFICATIONS. THE OUT-OF-LIMIT PULSING CURRENT COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF SERVICE CONDITION, HOWEVER, RESULTS OF THE BATTERY LONGEVITY PREDICTION CONFIRM THAT THE END OF SERVICE CONDITION WAS AN EXPECTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 6055

    Patients

    Seq Age Sex Outcome Treatment
    1