BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROCYBERNETIC PROSTHESIS

    MDR report key: 245555 · Received October 20, 1999

    Report

    Report Number
    MW1017365
    Event Type
    Injury
    Date Received
    October 20, 1999
    Report Date
    October 19, 1999
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A CYBERONICS VAGAL NERVE STIMULATOR IMPLANTED 2 WKS AGO. STIMULATOR TURNED ON 10/18/1999. PT HAD AN ACUTE MI 3-4 HRS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROCYBERNETIC PROSTHESIS Implant VAGAL NERVE STIMULATOR GENERATOR LYJ CYBERONICS, INC. 100 26853C
    2 NEUROCYBERNETIC PROSTHESIS Implant VAGAL NERVE STIMULATOR LEAD LYJ CYBERONICS, INC. 300 2410JC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L NEURONTIN 3600MG/D| DILANTIN 400MG/D