BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2903912 · Received January 9, 2013

    Report

    Report Number
    1644487-2013-00107
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    August 30, 2009
    Report Date
    December 12, 2012
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    UPON REVIEW OF THE IN-HOUSE PROGRAMMING HISTORY DATABASE, IT WAS OBSERVED THAT A GENERATOR DIAGNOSTICS TEST WAS PERFORMED ON (B)(6) 2009 WHICH CHANGED THE PATIENT'S SETTINGS TO UNINTENDED PARAMETERS. THE SETTINGS WERE NOT CORRECTED UNTIL THE PATIENT'S NEXT VISIT ON (B)(6) 2010. NO PATIENT ADVERSE EVENTS WERE REPORTED. MANUFACTURER LABELING INDICATES THAT GENERATOR DIAGNOSTIC TESTS SHOULD ONLY BE PERFORMED IN THE OPERATING ROOM TO TEST THE DEVICE AND SHOULD NOT BE PERFORMED AT FOLLOW-UP VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11134 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other