BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1061301 · Received June 13, 2008

    Report

    Report Number
    1644487-2008-01370
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT WAS EXPERIENCING PERIODIC MYOCLONIC JERKS. CLARIFICATION FROM THE SITE REVEALED THAT THE EVENT WAS MYOCLONIC SEIZURE ACTIVITY, AND THAT THE PT HAD A HISTORY OF THESE TYPES OF SEIZURES. THE PATIENT'S CURRENT SEIZURE LEVEL IS ABOVE PREVNS BASELINE. VNS SETTINGS WERE ADJUSTED AND MEDICATION CHANGES WERE MADE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention