BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1190856 · Received September 24, 2008

    Report

    Report Number
    1644487-2008-02328
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 24, 2008
    Report Date
    August 26, 2008
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PATIENT'S "SEIZURE COUNT MAY NOT BE NORMAL". A BATTERY ESTIMATE YIELDED 2.03 YEARS REMAINING ON THE VNS GENERATOR. 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 009771

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR