BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1801201 · Received August 11, 2010

    Report

    Report Number
    1644487-2010-01841
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 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 VNS PT WAS HAVING INCREASED SEIZURES. A BATTERY ESTIMATE PERFORMED FOR THE GENERATOR REVEALED THE YEARS REMAINING WAS NEGATIVE, INDICATING VNS END OF SERVICE IS LIKELY NEARING. GENERATOR REPLACEMENT SURGERY APPEARS LIKELY. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 013382

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention