BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 100

    MDR report key: 1400101 · Received June 5, 2009

    Report

    Report Number
    1644487-2009-01145
    Event Type
    Injury
    Date Received
    June 5, 2009
    Date of Event
    September 26, 2000
    Report Date
    May 28, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: KOUTROUMANIDIS, MICHAEL, MICHAEL J. HENNESSY, COLIN D. BINNIE, AND CHARLES E. POLKEY. "AGGRAVATION OF PARTIAL EPILEPSY AND EMERGENCE OF NEW SEIZURE TYPE DURING TREATMENT WITH VNS." NEUROLOGY 55 (2000): 892-93.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT A VNS PATIENT, WHO HAD INITIALLY RESPONDED TO VNS THERAPY, BEGAN TO EXPERIENCE AN "ABRUPT WORSENING OF HER EPILEPSY" AFTER INCREASING HER THERAPY OUTPUT CURRENT BY 0.25MA (2.25MA TO 2.50MA). THE AUTHOR INDICATED THAT THIS WORSENED SEIZURE ACTIVITY CONSISTED OF AN INCREASE IN SEIZURE FREQUENCY, ABOVE PRE-VNS BASELINE LEVELS, AS WELL AS THE DEVELOPMENT OF A NEW SEIZURE TYPE. THE ARTICLE STATES THAT THE PATIENT HAD "NO HISTORY OF RECENT AED CHANGES OR DOSE OMISSION, PROTRACTED SLEEP DEPRIVATION, STRESSFUL EVENTS, TRAUMA, OR INTERVENING INFECTION COULD BE ELICITED AND BOTH THE GENERATOR AND THE LEAD WERE FUNCTIONING NORMALLY". THE AUTHOR STATES THAT ONCE THE PATIENT'S NCP DEVICE WAS PROGRAMMED OFF, "2 DAYS LATER THE NEW SEIZURE TYPE CEASED AND THE PATIENT'S HABITUAL SEIZURES SETTLED DOWN TO PRE-IMPLANTATION BASELINE." IN LIGHT OF THESE EVENTS, THE PT'S DEVICE WAS REPORTEDLY PROGRAMMED BACK ON A MONTH LATER DUE TO THE INITIAL EFFICACY SHE HAD RECEIVED FROM VNS THERAPY. THE PT'S OUTPUT CURRENT WAS GRADUALLY INCREASED UP TO 1.75MA AND AFTER SIX MONTHS OF FOLLOW UP, THE PATIENT REPORTEDLY REGAINED THE EFFICACY THAT SHE HAD INITIALLY OBTAINED WITH NO RELAPSE OF THE NEW SEIZURE TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 100 LYJ CYBERONICS, INC. 100 C

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention