BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1678645 · Received May 7, 2010

    Report

    Report Number
    1644487-2010-01117
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    January 1, 2005
    Report Date
    April 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    MANUFACTURER REVIEW OF THE PUBLISHED JOURNAL ARTICLE "GENERATOR REPLACEMENT IN EPILEPSY PTS TREATED WITH VAGUS NERVE STIMULATION, SEIZURE (2005) 14, 89-99. VONCK K, DEDEURWAERDERE S, DE GROOTE L, THADANI V, CLAEYS P, GOSSIAUX F, VAN ROOST D, BOON P" REVEALED A PT HAD INCREASED SEIZURES WITH STATUS EPILEPTICUS REQUIRING HOSPITALIZATION AFTER VNS GENERATOR REPLACEMENT SURGERY. MEDICATION WAS ALSO ADDED AS AN INTERVENTION. THE PT NEVER REGAINED SEIZURE CONTROL TO THE DEGREE THE PT HAD WITH THE PREVIOUS VNS GENERATOR AT THE TIME OF ARTICLE SUBMISSION. IT IS POSSIBLE THIS EVENT HAS BEEN PREVIOUSLY REPORTED, BUT CANNOT BE CONFIRMED AT THIS TIME. ATTEMPTS FOR FURTHER INFO FROM THE LEAD AUTHOR ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1