BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3070801 · Received April 22, 2013

    Report

    Report Number
    1644487-2013-01111
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    November 30, 2005
    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 Occupation
    OTHER

    Narratives

    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 GENERATOR DIAGNOSTIC TEST ALTERED DEVICE SETTINGS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172368 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1