BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1963292 · Received January 14, 2011

    Report

    Report Number
    1644487-2011-00068
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WHO HAS BEEN IMPLANTED FOR ONE YEAR HAS A HISTORY OF HORMONAL PROBLEMS, AND SINCE BEING GIVEN A GROWTH HORMONE TWO WEEKS AGO, TONIC CLONIC SEIZURES ARE THOUGHT TO BE WORSE. THE PT'S ENDOCRINOLOGIST DOES NOT ATTRIBUTE THE WORSENING OF SEIZURES TO THE MEDICATION, DESPITE THE COINCIDENCE. NO INTERVENTIONS HAVE BEEN TAKEN OR PLANNED TO DATE. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other