BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2915811 · Received January 15, 2013

    Report

    Report Number
    1644487-2013-00156
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    March 15, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY EVENT DATE, CORRECTED DATA - ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE EVENT DATE WAS INCORRECT. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. SERIAL NUMBER, CORRECTED DATA - ADDITIONAL INFORMATION WAS RECEIVED INDICATING SERIAL NUMBER OF THE HANDHELD COMPUTER. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    REVIEW OF ADDITIONAL AND ADJUSTED PROGRAMMING HISTORY IDENTIFIED THE THE EVENT DATE AS (B)(6) 2012. PRODUCT INFORMATION WAS ALSO OBTAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS INTERROGATED AND THE SETTINGS WERE NOTED TO BE OUTPUT=0MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=0MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC. THESE SETTINGS ARE INDICATIVE OF A FAULTED SYSTEM DIAGNOSTICS TEST. THE PATIENT HAD PREVIOUSLY BEEN INTERROGATED ON (B)(6) 2011 AND THE SETTINGS WERE OUTPUT=0.5MA/FREQUENCY=30HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=1.8MIN/MAGNET OUTPUT=0.75MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC. THERE WAS NO INDICATION THAT THE DEVICE HAD BEEN PROGRAMMED OFF PURPOSEFULLY. THE DATES WERE INCORRECT IN THE PHYSICIAN'S HANDHELD SO THEY WERE UNABLE TO DISCERN ANY FURTHER INFORMATION FROM THE PROGRAMMING HISTORY. THE PATIENT WAS INTERROGATED AT A LATER TIME AND WAS REPROGRAMMED BACK TO THE CORRECT SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23102 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR