BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1840045 · Received September 15, 2010

    Report

    Report Number
    1644487-2010-02091
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    July 26, 2006
    Report Date
    August 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF PROGRAMMING HISTORY FOR THIS VNS PT'S IMPLANTED PULSE GENERATOR TO PERFORM A BATTERY LIFE CALCULATION, IT WAS OBSERVED THAT ON (B)(6) 2006, AFTER THE DEVICE WAS INITIALLY INTERROGATED, A SYSTEM DIAGNOSTIC TEST WAS PERFORMED BY THE PHYSICIAN WHICH "FAULTED" AND THE TEST DID NOT COMPLETE. THE PHYSICIAN THEN RE-INTERROGATED THE DEVICE AGAIN AND THE SETTINGS WERE REPROGRAMMED TO THE SYSTEM DIAGNOSTIC TEST SETTINGS. THE PHYSICIAN DID NOT RE-PROGRAM THE SETTINGS TO THE INITIALLY INTERROGATED SETTINGS, AND THUS THE PT LEFT THE OFFICE AS THE UNINTENDED SETTINGS. THE PT'S DEVICE WAS INTERROGATED NEXT ON (B)(6) 2006, WHERE THE SETTINGS WERE PROGRAMMED BACK TO THE INTENDED SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 364709

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR