BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1091609 · Received July 31, 2008

    Report

    Report Number
    1644487-2008-01759
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 2, 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

    INITIAL REPORTER INDICATED THAT THEY "HAD 11 SEIZURES IN THE LAST 3 DAYS SO THINKS HIS BATTERY IS DEAD." FOLLOW UP WITH THE PATIENT'S TREATING PHYSICIAN BELIEVED THE CAUSE FOR THE PATIENT'S INCREASED SEIZURES WAS THE PATIENT'S GENERATOR NEARING END OF BATTERY LIFE. THE PATIENT'S VNS SETTINGS AND MEDICATIONS WERE INCREASED. DIAGNOSTICS PERFORMED IN THE OFFICE SHOWED THE GENERATOR WAS ABLE TO DELIVER THE PROGRAMMED SETTINGS AND ALL WITHIN NORMAL LIMITS. ELECTIVE REPLACEMENT INDICATOR NO. THE PATIENT'S REPORTED INCREASE IN SEIZURES WERE ABOVE THEIR PRE VNS SEIZURE RATE. THE PHYSICIAN WILL CHECK THE VNS MONTHLY. PATIENT WILL BE REFERRED FOR A PSYCHOLOGICAL EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 3791

    Patients

    Seq Age Sex Outcome Treatment
    1 Other