BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1061902 · Received June 16, 2008

    Report

    Report Number
    1644487-2008-01385
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT HAD GENERATOR REPLACEMENT SURGERY DUE TO "GENERATOR FAILURE". THE GENERATOR HAD BEEN IMPLANTED FOR SEVEN YEARS. NO VNS PROGRAMMING HISTORY IS AVAILABLE SO GENERATOR END OF SERVICE CANNOT BE CONFIRMED. ATTEMPTS FOR FURTHER INFO FROM THE REPORTER HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED GENERATOR HAS BEEN RETURNED AND IS CURRENTLY IN PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 2408

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR