BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2101674 · Received May 11, 2011

    Report

    Report Number
    1644487-2011-01062
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT WAS HAVING INCREASED GRAND MAL SEIZURES. ATTEMPTS FOR FURTHER INFORMATION FROM THE PATIENT'S TREATING NEUROLOGIST ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2565

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention