BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3043223 · Received April 9, 2013

    Report

    Report Number
    1644487-2013-00961
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 9, 2009
    Report Date
    March 24, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF INTERNAL PROGRAMMING HISTORY IT WAS NOTED THAT ON (B)(6) 2009 THE DEVICE WAS INTERROGATED AND THE SETTINGS WERE 2.75/30/500/30/1.8, A SYSTEM DIAGNOSTIC TEST WAS PERFORMED AND THE PATIENT LEFT THE VISIT. ON THE FIRST INTERROGATION OF THE NEXT RECORDED VISIT (B)(6) 2009 THE SETTINGS WERE 0/20/500/30/60 WHICH ARE INDICATIVE OF AN INTERRUPTED SYSTEM DIAGNOSTIC. NO PROGRAMMING HISTORY AFTER THIS EVENT IS AVAILABLE FOR REVIEW.

    Description of Event or Problem · 1

    THE PATIENT WAS SEEN SINCE THE REPORTED EVENT AND HAS HAD THEIR GENERATOR REPLACED FOR END OF BATTERY LIFE. THE PHYSICIAN WAS AWARE OF THE CAUSE OF THEIR FAULTED TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146674 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521422

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR