BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3070789 · Received April 22, 2013

    Report

    Report Number
    1644487-2013-01106
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    WHILE REVIEWING THE PATIENT'S PROGRAMMING HISTORY ON (B)(4) 2013 A PROGRAMMING ANOMALY WAS OBSERVED ON (B)(6) 2004. THE PATIENT WAS NOTED TO BE AT FAULTED DIAGNOSTIC TEST SETTINGS. THE PATIENT WAS INTERROGATED ON THIS DATE AT SETTINGS OF 1MA / 20 SF / 500 PW / 30 SECONDS ON TIME/ 60 SECONDS OFF TIME. THE PATIENT'S SETTINGS WERE ADJUSTED AT THE SAME VISIT TO 0.75MA / 20 SF / 500 PW / 30 SECONDS ON TIME / 5 MINUTES OFF TIME PRIOR TO THE PATIENT LEAVING THE OFFICE. IT IS UNKNOWN THE EXACT DATE THE PROGRAMMING ANOMALY OCCURRED THAT CHANGED THE PATIENT SETTINGS. BASED ON AVAILABLE DATA IT IS UNKNOWN WHO THE PATIENT'S FOLLOWING PHYSICIAN WAS AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172364 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC 250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1