BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2930269 · Received January 25, 2013

    Report

    Report Number
    1644487-2013-00219
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    October 28, 2003
    Report Date
    January 4, 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

    DURING REVIEW OF THE VNS PATIENT'S PROGRAMMING HISTORY ON (B)(6) 2013 IT WAS DISCOVERED THAT A FAULTED SYSTEM DIAGNOSTICS TESTS OCCURRED, WHICH CHANGED THE PATIENT'S SETTINGS. ON (B)(6) 2003 A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED AND NO FINAL INTERROGATION WAS PERFORMED. THE PATIENT THEN PRESENTED AT THE NEXT VISIT ON (B)(6) 2003 WITH THE INCORRECT SETTINGS OF OUTPUT=1MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=1MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC. THE PATIENT WAS THEN REPROGRAMMED TO THE DESIRED SETTINGS. NO PATIENT HARM HAS BEEN REPORTED TO HAVE OCCURRED DUE TO THESE SETTINGS CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36004 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR