BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3071628 · Received April 22, 2013

    Report

    Report Number
    1644487-2013-01119
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED MDR INADVERTENTLY SUBMITTED THE INCORRECT PATIENT IDENTIFIER. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF PROGRAMMING HISTORY, IT WAS NOTED THAT A FAULTED SYSTEM DIAGNOSTIC TEST LIKELY CHANGED DEVICE SETTINGS. WHILE NO FINAL OR SUBSEQUENT INTERROGATION IS AVAILABLE, A NORMAL MODE DIAGNOSTIC PERFORMED AFTER MULTIPLE FAULTED SYSTEM DIAGNOSTIC TESTS SHOW RESULTS TYPICAL FOR A DEVICE PROGRAMED TO A 0 MA OUTPUT CURRENT; HOWEVER, THE DEVICE WAS NOT INTERROGATED OR PROGRAMMED TO A 0 MA OUTPUT CURRENT PRIOR TO THE NORMAL MODE DIAGNOSTIC TEST. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172470 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1