BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1902356 · Received November 11, 2010

    Report

    Report Number
    1644487-2010-02543
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT HAD BEEN REFERRED FOR REMOVAL OF HER VNS. THE PT'S MOTHER BELIEVES THAT THE PT'S SEIZURES HAVE INCREASED SINCE THE VNS HAS BEEN IMPLANTED; HOWEVER, THE SURGEON'S OFFICE SUSPECTS THE DEVICE MAY HAVE BEEN PROGRAMMED OFF FOR A FEW MONTHS. FURTHER ATTEMPTS FOR INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200939

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention