BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1241166 · Received November 20, 2008

    Report

    Report Number
    1644487-2008-02747
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 21, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY. GENERATOR END OF SERVICE HAS BEEN RULED OUT AS A CAUSE FOR THE INCREASE THROUGH DEVICE DIAGNOSTIC RESULTS. FURTHER FOLLOW UP REVEALED THAT THE PATIENT HAS BEEN FACING ISSUES WITH HER SHUNT; THEREFORE, THE PATIENT'S SHUNT WAS REPLACED. IT WAS ALSO INDICATED THAT THE PATIENT HAS BEEN WEANING HERSELF OFF OF EPILEPSY MEDICATION BY CHOICE. PER TREATING PHYSICIANS, THE CAUSE OF THE RELATIONSHIP BETWEEN THE INCREASE AND VNS THERAPY IS UNKNOWN BUT OTHER POSSIBLE CAUSES FOR THE INCREASE ARE BELIEVED TO BE ISSUES WITH THE SHUNT AND NON-COMPLIANCE WITH MEDICATION. THE PATIENT'S GENERATOR WAS REPLACED PROPHYLACTICALLY AND HAS BEEN RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 4084

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention