BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1822573 · Received August 27, 2010

    Report

    Report Number
    1644487-2010-01963
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    January 1, 2008
    Report Date
    July 30, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT WAS HAVING HEAD MOVEMENTS THOUGHT TO BE SEIZURES IN 2008. AFTER THE VNS SETTINGS WERE DECREASED, THE HEAD MOVEMENTS IMPROVED. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 NONE LYJ CYBERONICS, INC. 102 010275

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention