BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1202210 · Received October 16, 2008

    Report

    Report Number
    1644487-2008-02496
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    August 6, 2008
    Report Date
    October 9, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT HAD HIS DEVICE EXPLANTED PROPHYLACTICALLY DUE TO END OF SERVICE. PRODUCT WAS RETURNED TO MFR AND ANALYSIS WAS DONE. UPON ANALYSIS, THE BATTERY END OF SERVICE WAS CONFIRMED. IT WAS ALSO FOUND THAT THE CAGED MODULE EXHIBITED AN OUT-OF-LIMIT (HIGH) PULSING CURRENT AND THAT THE R35 RESISTOR COULD HAVE BEEN MORE OPTIMALLY CHOSEN DURING MANUFACTURE. USING THE NEXT LOWER VALUE RESISTOR, THE CAGED MODULE MET ALL SPECIFICATIONS. THE OUT-OF-LIMIT PULSING CURRENT COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF SERVICE; HOWEVER, RESULTS OF THE BATTERY LONGEVITY PREDICTION CONFIRM THAT THE END OF SERVICE CONDITION WAS AN EXPECTED EVENT. NO OTHER ANOMALIES WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR