BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1783947 · Received July 30, 2010

    Report

    Report Number
    1644487-2010-01768
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 1, 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. VNS GENERATOR REPLACEMENT IS PLANNED AS AN INTERVENTION, BUT THE SURGERY WILL NOT BE SCHEDULED UNTIL THE END OF (B)(6) 2010, DUE TO FAMILY REQUESTS. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 011808

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention