BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4163649 · Received October 10, 2014

    Report

    Report Number
    1644487-2014-02631
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 16, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WENT TO THE ER DUE TO MULTIPLE SEIZURES. THE PATIENT HAD BEEN PREVIOUSLY SEIZURE FREE AND MAGNET ACTIVATIONS WERE NOT PREVENTING SEIZURES. IT WAS DETERMINED THAT THE PATIENT¿S MEDICATION LEVEL WAS TOO LOW. THE PATIENT¿S MEDICATION AND DEVICE SETTINGS WERE INCREASED IN THE ER. THE EVENTS WERE INITIALLY BELIEVED TO BE DUE TO LOW MEDICATION LEVELS; HOWEVER, FOLLOW-UP WITH THE PATIENT¿S PHYSICIAN INDICATED THAT THE EVENT¿S RELATIONSHIP TO VNS IS INCONCLUSIVE. THE PHYSICIAN STATED THAT THE PATIENT¿S LOW DEVICE SETTINGS AND MEDICAL NONCOMPLIANCE WITH OFFICE VISITS MAY BE CONTRIBUTING FACTORS. THE PATIENT¿S DEVICE WAS TESTED AND DIAGNOSTIC SHOWED NORMAL DEVICE FUNCTION. THE PATIENT¿S INCREASE IN SEIZURES WAS ABOVE PRE-VNS BASELINE LEVELS. THE PATIENT¿S MAGNET SWIPING HAD NOT BEEN OBSERVED TO CONFIRM PROPER TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639134 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 2565

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention