BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3050178 · Received April 10, 2013

    Report

    Report Number
    1644487-2013-00973
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 26, 2008
    Report Date
    March 14, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY CONFIRMED EVENT.

    Description of Event or Problem · 1

    WHILE PERFORMING AN INTERNAL REVIEW OF PROGRAMMING HISTORY IT WAS NOTED THAT ON THE DAY OF IMPLANT, (B)(6) 2008 THE DEVICE WAS INTERROGATED TWICE AND THE SETTINGS WERE 0/30/500/30/180, THREE SYSTEM DIAGNOSTICS WERE PERFORMED AND RESULTED IN "FAULT", A THIRD AND FINAL INTERROGATION WAS PERFORMED AND THE SETTINGS WERE 1/20/500/30/60 AND WERE NOT CORRECTED PRIOR TO THE PATIENT LEAVING THE IMPLANT SURGERY. THEIR SETTINGS WERE LATER CORRECTED ON (B)(6) 2008 TO 1MA OUTPUT CURRENT, 30 SIGNAL FREQUENCY, 500 PULSE WIDTH, 30 SECONDS ON TIME, 5 MINUTES OFF TIME. NO ADVERSE EVENTS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153117 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS 250 521399

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR