BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1864290 · Received October 7, 2010

    Report

    Report Number
    1644487-2010-02254
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT WAS EXPERIENCING GAGGING, COUGHING AND CRYING WITH VNS STIMULATION. VNS DIAGNOSTICS PERFORMED INDICATED PROPER DEVICE FUNCTION, BUT THE VNS WAS DISABLED AT THE REQUEST OF THE PT'S PARENTS; ONLY THE MAGNET MODE SETTING WAS LEFT ON IF NEEDED. THE PT LATER HAD GENERATOR REPLACEMENT SURGERY. ATTEMPTS FOR FURTHER INFO AND RETURN OF THE EXPLANTED GENERATOR ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS INC. 102R 200637

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention