BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2181399 · Received July 21, 2011

    Report

    Report Number
    1644487-2011-01650
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT HAD BEEN EXPERIENCING AN INCREASE IN THE FREQUENCY OF HER SEIZURES. THE PATIENT'S VNS INDICATED IT WAS AT OR NEAR END OF SERVICE HOWEVER IT CAN NOT BE CONFIRMED IF THE VNS IS ABLE TO DELIVER THE INTENDED STIMULATION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SURGERY TO REPLACE THE PATIENT'S GENERATOR IS LIKELY.

    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 17 YR Required Intervention