BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2000337 · Received February 18, 2011

    Report

    Report Number
    1644487-2011-00300
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    October 7, 2010
    Report Date
    January 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING AN INCREASE IN SEIZURES BELIEVED TO BE DUE TO VNS GENERATOR END OF SERVICE. THE GENERATOR WAS REPLACED AND THE EXPLANTED PRODUCT WAS RETURNED FOR ANALYSIS. ANALYSIS OF THE GENERATOR WAS FOUND THAT ALTHOUGH THE ELECTIVE REPLACEMENT INDICATOR WAS SET, THE GENERATOR WAS ABLE TO DELIVER THE INTENDED STIMULATION. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 011252

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention