BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3021031 · Received March 26, 2013

    Report

    Report Number
    1644487-2013-00804
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 8, 2013
    Report Date
    March 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS DISCOVERED THAT THE PATIENT'S EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS AT SETTINGS INDICATIVE OF A FAULTED SYSTEM DIAGNOSTICS TEST; OUTPUT=1MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=1MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC. NO PATIENT ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED DUE TO THESE SETTINGS. GOOD FAITH ATTEMPTS FOR FURTHER PROGRAMMING HISTORY HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123664 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR