BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1192118 · Received October 7, 2008

    Report

    Report Number
    1644487-2008-02425
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    July 2, 2008
    Report Date
    September 8, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT AS REPORTED THAT THE PT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE PT HAD HIS GENERATOR PROPHYLACTICALLY REPLACED AS THE GENERATOR IS NOT CURRENTLY AT END OF SERVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO AND EXPLANTED PRODUCT FOR PRODUCT ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1