BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2160598 · Received July 6, 2011

    Report

    Report Number
    1644487-2011-01511
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S SEIZURES HAVE BEEN WORSENING IN FREQUENCY AND INTENSITY. IT IS UNK IF THE SEIZURES ARE WORSE THAN PRE-VNS LEVELS AS THE PT HAS BEEN IMPLANTED FOR SOME TIME. THE PHYSICIAN WAS NOT AWARE WHEN THE PT'S SEIZURES BEGAN WORSENING. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 010960

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention