BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2190779 · Received July 26, 2011

    Report

    Report Number
    1644487-2011-01685
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    April 26, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES THAT A VNS PT WAS HAVING A SLIGHT INCREASE IN SEIZURES, ABOUT 5-6 SEIZURES PER MONTH. THE PT'S VNS SETTINGS HAVE BEEN INCREASED TO OUTPUT CURRENT=2.25MA AND ON TIME=14 SECONDS. PT HAS BEEN REFERRED TO SURGEON FOR PROPHYLACTIC GENERATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 010763

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention