BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3800991 · Received May 8, 2014

    Report

    Report Number
    1644487-2014-01230
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 11, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS RECENTLY HAD TWO SEIZURES IN THREE WEEKS. THE PATIENT REPORTED THAT SHE NEEDS TO FIND A NEUROLOGIST TO MAKE SOME ADJUSTMENTS TO THE VNS BECAUSE THE DEVICE WAS WORKING WELL UNTIL THE SEIZURES. THE PATIENT INDICATED THAT THE SEIZURES COULD BE STRESS RELATED. THE PATIENT REPORTED THAT SHE CAN FEEL THE DEVICE WORKING. THE PATIENT HAS RECENTLY MOVED TO A NEW STATE AND WAS GIVEN NAMES OF PHYSICIANS TO CONTACT. IT IS UNKNOWN IF THE SEIZURES ARE AN INCREASE ABOVE THE PATIENT'S PRE-VNS BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277288 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3754

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR