BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1131063 · Received August 20, 2008

    Report

    Report Number
    1644487-2008-01964
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 21, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT WAS EXPERIENCING CHATTERING IN HER TEETH, LEFT ARM GOING UP AND DOWN, WHOLE BODY MUSCLE SPASMS, AND HARSHNESS WITH MUSCLES IN HER THROAT WITH MAGNET MODE STIMULATION. THE PT WAS HOSPITALIZED AND REPORTED THAT SHE WAS OVERDOSED ON DILANTIN. DISABLING THE VNS DEVICE WITH THE MAGNET DID NOT RESOLVE THE TEETH CHATTERING EVENT. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention