BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1508246 · Received October 14, 2009

    Report

    Report Number
    1644487-2009-02303
    Event Type
    Injury
    Date Received
    October 14, 2009
    Date of Event
    January 1, 2006
    Report Date
    September 14, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS THERAPY PT WAS GOING TO UNDERGO A GENERATOR REPLACEMENT SURGERY DUE TO NORMAL END OF SERVICE. CLINICAL NOTES RECEIVED FROM THE TREATING PHYSICIAN INDICATED THE PT "AT PRESENT, SHE CONTINUES TO HAVE INTRACTABLE SEIZURES. SHE CONTINUES TO HAVE VERY FREQUENT AURAS AND COMPLEX PARTIAL SEIZURES...SHE IS ALSO HAVING AT LEAST ONE GENERALIZED SEIZURE PER MONTH" "GIVEN HER CONTINUED INTRACTABLE SEIZURES...LONG TERM VIDEO EEG MONITORING WAS RECOMMENDED TO FURTHER CHARACTERIZE AND LOCALIZE HER SEIZURES." THE RELATIONSHIP OF THE SEIZURES TO VNS IS UNK. REVISION SURGERY IS LIKELY. GOOD FAITH ATTEMPTS OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 011066

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention