BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2258019 · Received August 25, 2011

    Report

    Report Number
    1644487-2011-01989
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    January 24, 2011
    Report Date
    August 3, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN CLINIC NOTES THAT VNS HAD HELP CONSIDERABLE IN THE BEGINNING TO "PREVENT THE SLIDE" HOWEVER IT IS FELT THAT THE PT HAS GOTTEN USE TO IT AND IS BEGINNING TO "SLIDE" AGAIN. IT IS UNCLEAR AT THIS TIME OF "SLIDE" REFERS TO AN INCREASE IN SEIZURES. AT THE SAME APPOINTMEN,T IT REPORTS THAT THE PT'S 23-HOUR EEG RESULTS DATED (B)(6) 2010 SHOWED APPROX. 70% IMPROVEMENT IN EPILEPTIFORM ACTIVITY FROM PREVIOUS EEG DONE IN (B)(6) 2010 PRIOR TO VNS PLACEMENT. GOOD FAITH ATTEMPTS FOR MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2631

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR