BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6064918 · Received October 28, 2016

    Report

    Report Number
    1644487-2016-02486
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDICAL PROFESSIONAL THAT THE PATIENT'S SEIZURE LEVEL WAS BELOW PRE-VNS LEVELS AND THAT THE VNS HAD GREATLY IMPROVED THE PATIENT'S SEIZURES. IT WAS REPORTED THAT IT IS NOT CLEAR THAT THE PATIENT'S EVENTS ARE EVEN SEIZURES AS AN EEG SCAN SHOWS THAT IT WAS "NORMAL." THE PHYSICIAN DID NOT BELIEVE THE EVENTS WERE RELATED TO THE VNS. IT WAS ALSO REPORTED THAT THE PATIENT WAS ABSORBING THE MEDICATION BUT NOT THE MEDICATION CAPSULES. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LARGE INCREASE IN SEIZURES ON THE DAY OF THE REPORT AND HER MAGNET WAS NOT ABORTING THEM. THE PATIENT'S SISTER REPORTED THAT THE PATIENT WAS NOT DIGESTING HER MEDICATION, BUT ACCORDING TO THE DOCTOR, SHE IS ABSORBING THE MEDICATION PER RECENT BLOOD TESTS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714299 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 202238

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR