BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1872832 · Received October 14, 2010

    Report

    Report Number
    1644487-2010-02305
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 15, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT EXPERIENCED A NEW TYPE OF SEIZURE AS THE PT BEGAN TO EXPERIENCE BRIEF TONIC-CLONIC SEIZURES THAT LASTED 10-20 SECONDS AND WERE INCREASING IN FREQUENCY. THE PT HAD RECENTLY UNDERGONE VNS PLACEMENT AND WAS NOT PROGRAMMED ON AFTER SURGERY. THE PT WAS PROGRAMMED ON AT A FOLLOW-UP APPOINTMENT WITH THE TREATING NEUROLOGIST. THE NEUROLOGIST BELIEVED THE INCREASE IN CHANGE WAS POSSIBLY DUE TO THE ANESTHESIA OR TRAUMA/STRESS BUT COULD NOT CONFIRM. ADDITIONAL INFO WAS RECEIVED THROUGH A FAX WITH CLINIC NOTES WHICH STATED: "THERE HAS BEEN AN INCREASE OF SEIZURE FREQUENCY, ESPECIALLY BRIEF EPISODES. GIVEN HIS INCREASED SEIZURE FREQUENCY, I AM RECOMMENDING CHECKING DRUG LEVELS TODAY. VNS WAS ALSO STARTED AT .25 MA EVER 180 MIN. HE APPEARED TO TOLERATE THIS PROCEDURE WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS INC 103 2740

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention