BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1063531 · Received June 19, 2008

    Report

    Report Number
    1644487-2008-01430
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 12, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT'S GENERATOR HAD BEEN FOUND TO BE RESET TO AN OUTPUT CURRENT OF 0 MA UPON INTERROGATION. REVIEW OF THE PATIENT'S PROGRAMMING HISTORY CONFIRMED A BURST WATCHDOG TIMEOUT HAD OCCURRED, CAUSING THE GENERATOR TO BE DISABLED. THE PATIENT'S VNS WAS REACTIVATED, AND NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE GENERATOR BEING SET TO ZERO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR