BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3803260 · Received May 9, 2014

    Report

    Report Number
    1644487-2014-01238
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 15, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT BEGAN EXPERIENCING AN INCREASE IN SEIZURES IN FEBRUARY 2014 AND WAS NO LONGER ABLE TO FEEL MAGNET MODE STIMULATION. THE PATIENT WAS HAVING DIFFICULTY STAYING AWAKE DUE TO THE NUMBER OF SEIZURES HE WAS EXPERIENCING. IT IS UNCLEAR WHETHER THE INCREASE IN SEIZURES WAS ABOVE OR BACK TO PRE-VNS BASELINE LEVELS. THE PATIENT¿S DEVICE WAS NOT AT END OF SERVICE AND DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION AT THE TIME. THE PATIENT ALSO REPORTED EXPERIENCING SOME DISCOMFORT BUT IT IS UNKNOWN WHETHER THE DISCOMFORT IS RELATED TO VNS. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY REVEALED APPROXIMATELY 1.41 YEARS UNTIL ERI = YES.

    Description of Event or Problem · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282014 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015424

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR