BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2981518 · Received February 27, 2013

    Report

    Report Number
    1644487-2013-00538
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    May 16, 2006
    Report Date
    February 5, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED AND IT WAS OBSERVED THAT ON (B)(6) 2005, THE PATIENT PRESENTED AT SETTINGS OF OUTPUT=0MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=0MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC WHICH ARE INDICATIVE OF A FAULTED SYSTEM DIAGNOSTICS TEST. NO ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED DUE TO THIS SETTINGS CHANGE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PHYSICIAN REPORTED THAT HE WOULD BE PROVIDING ADDITIONAL PROGRAMMING HISTORY BUT IT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83670 PROGRAMMING SOFTWARE PROGRAMMING SOFTWAR LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR