BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1905379 · Received November 18, 2010

    Report

    Report Number
    1644487-2010-02602
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    June 1, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTES DATED (B)(6) 2010 THAT THE PT WAS DOING WELL WITH ONLY 2-3 SEIZURES PER WEEK; HOWEVER, 2 WEEKS AGO, PT STARTED HAVING AN INCREASE IN SEIZURE FREQUENCY UP TO 1-2 PER DAY. CLINIC NOTES DATED (B)(6) 2010 STATED THAT THE PT'S SEIZURES HAVE IMPROVED SINCE INCREASE IN KEPPRA SINCE THE LAST VISIT. FOLLOW UP WITH THE PHYSICIAN REVEALED THAT THEY ARE NOT SURE ABOUT THE INCREASE IN SEIZURES AS THE PT HAS INTRACTABLE SEIZURES AND THEREFORE, IT IS HARD TO STATE IF ANY INCREASE IS RELATED TO VNS. THEY ARE NOT SURE IF THE INCREASE IN SEIZURES IS ABOVE PRE-VNS BASELINE. THEY DO NOT BELIEVE ANY EXTERNAL FACTORS OR MEDICATION CHANGES MIGHT HAVE CONTRIBUTED TO THE INCREASE IN SEIZURES. THE PHYSICIAN STATED THAT THE PT AT THIS TIME, HAS INCREASE IN SEIZURES ON AND OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 6507

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention