BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1901625 · Received November 12, 2010

    Report

    Report Number
    1644487-2010-02561
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT WAS HAVING INCREASED SEIZURES. THE PRE-VNS SEIZURE LEVEL WAS UNKNOWN AS THE PT WAS NEW TO THE REPORTER. VNS DEVICE DIAGNOSTICS INDICATED NORMAL DEVICE FUNCTION, AND THE GENERATOR WAS NOT AT END OF SERVICE. MEDICATION WAS ADJUSTED AS AN INTERVENTION, AND PROPHYLACTIC REPLACEMENT OF THE GENERATOR IS ALSO PLANNED DUE TO THE LENGTH OF IMPLANT (OVER 6 YEARS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS INC 102R 010644

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention