BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1870826 · Received October 11, 2010

    Report

    Report Number
    1644487-2010-02271
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 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 A NONVERBAL VNS PT WOULD CRY WHEN HIS VNS SETTINGS WERE ADJUSTED, AND IT APPEARED THE VNS STIMULATION WAS PAINFUL FOR THE PT. THE VNS WAS DISABLED AND THE PT HAS NOT CRIED SINCE PER THE MOTHER. EXPLORATORY VNS SURGERY WAS LATER PERFORMED ON (B)(6)2010 BUT NO DEVICES WERE EXPLANTED. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS INC 103 2349

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention