BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1910102 · Received November 10, 2010

    Report

    Report Number
    1644487-2010-02532
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    December 20, 2005
    Report Date
    October 11, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE CURRENT TREATING PHYSICIAN THAT IT WAS OBSERVED THAT THE PT'S PARAMETER OFF-TIME WAS SET TO 60 MINS OFF, WHICH DID NOT APPEAR TO BE AN INTENDED SETTING. THE PHYSICIAN DID NOT INTERROGATE THE PT'S DEVICE AT THAT THE PREVIOUS APPOINTMENT ON (B)(6) 2010. THE PT'S OFF-TIME WAS STILL AT 60 MINS OFF AT THAT TIME. A SEARCH PERFORMED IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE INDICATED THAT THE PT'S DEVICE SETTINGS WERE INADVERTENTLY CHANGED FOLLOWING AN UNSUCCESSFUL DIAGNOSTIC TEST, WHICH CHANGED HER OUTPUT CURRENT TO 1.0MA AND 60 MIN OFF. THE PT HAS SINCE HAD HER SETTINGS CHANGED WITH HER OFF-TIME CORRECTED. THE PT HAD MULTIPLE VISITS FOLLOWING THE CHANGE IN SETTINGS WHERE THE OUTPUT CURRENT WAS TITRATED UP AND NOT CORRECTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS INC 250 521431

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR