BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3122162 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01500
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    January 15, 2010
    Report Date
    April 24, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING MANUFACTURER REVIEW OF A PATIENT¿S VNS PROGRAMMING HISTORY, IT WAS IDENTIFIED THAT THE LAST VNS DIAGNOSTICS WERE PERFORMED ON (B)(6) 2010. SETTINGS PRIOR TO THE SYSTEMS TEST WERE 3.25MA/20HZ/250PULSEWIDTH/21SEC ON/0.8MIN OFF. A FINAL INTERROGATION WAS NOT PERFORMED AFTER THE SYSTEMS TEST ON (B)(6) 2010, AND AT THE NEXT OFFICE VISIT ON (B)(6) 2010 THE SETTINGS WERE 0MA/20HZ/500PULSEWIDTH/30SEC ON/60MIN OFF. THIS IS INDICATIVE OF A FAULTED SYSTEMS TEST, EVEN THOUGH THE TEST IS NOT NOTED AS FAULTED IN THE HISTORY. THE VNS SETTINGS WERE CORRECTED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224772 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR