BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1801195 · Received August 11, 2010

    Report

    Report Number
    1644487-2010-01852
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 12, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S MOTHER THAT THE VNS PT HAS RECENTLY BEEN EXPERIENCING AN INCREASE IN SEIZURES, WHICH IS BELIEVED TO BE ABOVE PRE-VNS BASELINE LEVELS. THE MOTHER ALSO NOTED THAT THE PT HAS BEEN HAVING DEEPER SLEEP, WHICH SHE BELIEVES IS RELATED TO HIS SEIZURE ACTIVITY. IT WAS ALSO INDICATED THAT FOLLOWING VNS IMPLANT, THE PT WAS ADMITTED FOR PNEUMONIA. GOOD FAITH ATTEMPT TO OBTAIN ADDITIONAL INFORMATION 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 2555

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization