BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2063728 · Received April 15, 2011

    Report

    Report Number
    1644487-2011-00823
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    December 9, 2010
    Report Date
    March 16, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES, COULD NO LONGER FEEL STIMULATION, AND WOULD BE HAVING HER GENERATOR REPLACED DUE TO END OF SERVICE. THE PATIENT NORMALLY EXPERIENCES ABOUT ONE SEIZURE PER MONTH WITH VNS THERAPY HOWEVER SHE EXPERIENCED TWO IN ONE DAY WITH ONE OF THE SEIZURES LASTING NOTABLY LONGER THAN NORMAL. SURGERY TO REPLACE THE PATIENT'S VNS GENERATOR HAS OCCURRED. THE EXPLANTED GENERATOR WAS RETURNED AND ANALYSIS FOUND THAT ALTHOUGH THE GENERATOR ELECTIVE REPLACEMENT INDICATOR WAS YES, THE GENERATOR SHOULD HAVE BEEN ABLE TO DELIVER THE INTENDED AMOUNT OF STIMULATION. NO ANOMALIES WERE FOUND WITH THE GENERATOR. FOLLOW-UP WITH THE PHYSICIAN FOUND THAT SHE BELIEVED THE SEIZURES TO BE DUE TO THE VNS GENERATOR END OF SERVICE AS INDICATED. THE PRE-VNS BASELINE SEIZURE FREQUENCY IS UNKNOWN AS THE PATIENT WAS IMPLANTED PRIOR TO SEEING THE CURRENT PHYSICIAN. NO EXTERNAL FACTORS ARE BELIEVED TO HAVE CONTRIBUTED TO THE INCREASE IN SEIZURES. THE PATIENT'S SEIZURES ARE BELIEVED TO HAVE IMPROVED SINCE REPLACEMENT AS NO COMPLAINTS OF A CONTINUED INCREASE HAVE BEEN MADE TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS INC 101 4919

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention