BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3243418 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02228
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    September 19, 2007
    Report Date
    June 27, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    A REVIEW OF THE PATIENT'S PROGRAMMING HISTORY FOUND THAT A FAULTED SYSTEM DIAGNOSTIC TEST WAS PERFORMED ON (B)(6) 2007, WHICH CHANGED THE PATIENT'S SETTINGS. THE PATIENT'S OUTPUT CURRENT WAS READJUSTED; HOWEVER, THE OFF TIME WAS NOT CORRECTED. THE REMAINING SETTINGS WERE ADJUSTED AT THE NEXT VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343467 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 521412

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR