BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3240714 · Received July 22, 2013

    Report

    Report Number
    1644487-2013-02208
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    April 22, 2011
    Report Date
    June 26, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE PATIENT'S PROGRAMMING HISTORY, IT WAS NOTED THAT A FAULTED SYSTEM DIAGNOSTIC TEST WAS PERFORMED ON (B)(6) 2011. A FINAL INTERROGATION WAS NOT PERFORMED AFTER THIS TEST, AND THE PATIENT WAS OBSERVED TO BE AT DIFFERENT SETTINGS UPON INITIAL INTERROGATION AT THE NEXT VISIT OF (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339998 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 584953

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR