BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2944858 · Received February 5, 2013

    Report

    Report Number
    1644487-2013-00297
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    November 29, 2011
    Report Date
    January 8, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2011 WERE RECEIVED TO THE MANUFACTURER FROM THE REPORTER INDICATING A PATIENT WAS HAVING A MARKED INCREASE IN GRAND MAL SEIZURES. VNS SETTINGS WERE ADJUSTED AS AN INTERVENTION. DIAGNOSTICS INDICATED NORMAL DEVICE FUNCTION, AND THE VNS WAS NOT AT END OF SERVICE. FOLLOW UP WITH THE REPORTER REVEALED THE INCREASED SEIZURES WERE ABOVE PRE-VNS BASELINE LEVELS AND WERE FELT TO BE DUE TO STRESS AND "VNS FAILURE". INTRAVENOUS ATIVAN MEDICATION WAS GIVEN AS AN INTERVENTION. UNSPECIFIED EXTERNAL FACTORS WERE ALSO FELT TO HAVE BEEN A CONTRIBUTING EVENT. REPLACEMENT OF THE VNS GENERATOR IS CURRENTLY PLANNED, BUT IS ON HOLD DUE TO INSURANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47923 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 7083

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention