BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3130385 · Received May 24, 2013

    Report

    Report Number
    1644487-2013-01595
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    September 26, 2005
    Report Date
    April 29, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 ON (B)(6) 2005 THE VNS DEVICE WAS INTERROGATED AND THE SETTINGS WERE 1.25MA/30HZ/500PULSEWIDTH/30SEC ON/5MIN OFF; A SYSTEMS DIAGNOSTICS TEST WAS PERFORMED AND RESULTED IN "FAULT", A SECOND SYSTEMS DIAGNOSTICS TEST WAS PERFORMED AND THE RESULTS WERE OUTPUT STATUS = OK, LEAD IMPEDANCE = OK, DCDC CODE = 2, EOS = NO. A FINAL INTERROGATION WAS NOT PERFORMED AND THE PATIENT LEFT THE VISIT. AT THE NEXT RECORDED VISIT DATED (B)(6) 2006 THE FIRST INTERROGATION SHOWED THE DEVICE SETTINGS WERE 0MA/30HZ/500PULSEWIDTH/30SEC ON/5MIN OFF, WHICH IS INDICATIVE OF "FAULTED" DIAGNOSTICS WHICH CHANGED THE SETTINGS AT THE PREVIOUS (B)(6) 2005 VISIT. THE SETTINGS WERE CORRECTED ON (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231594 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR