BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1132650 · Received August 22, 2008

    Report

    Report Number
    1644487-2008-01998
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT IS EXPERIENCING AN INCREASE IN SEIZURES. THE PT'S PRE-VNS SEIZURE LEVEL IS UNK. THE PT HAS BEEN REFERRED FOR GENERATOR REPLACEMENT DUE TO END OF SERVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L 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. 101 5549

    Patients

    Seq Age Sex Outcome Treatment
    1