BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2992556 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00618
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    June 10, 2010
    Report Date
    February 19, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 A FAULTED TEST OCCURRED ON (B)(6) 2010. A LEAD TEST WAS INTERRUPTED ON (B)(6) 2010, WHICH INADVERTENTLY CHANGED THE PATIENT'S SETTINGS TO LEAD TEST PARAMETERS AND NO INTERROGATION FOLLOWED IN THIS VISIT. IT WASN'T UNTIL (B)(6) 2011, THAT THE SETTINGS IN QUESTION WERE FOUND AND CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98187 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR