BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1905621 · Received November 19, 2010

    Report

    Report Number
    1644487-2010-02633
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE NURSE THAT THE PT WAS HAVING SOME CARDIAC ISSUES WHICH SHE ATTRIBUTES TO VNS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 012704

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening