BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3930168 · Received July 11, 2014

    Report

    Report Number
    1644487-2014-01763
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    November 2, 2013
    Report Date
    May 12, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING REVIEW OF THE IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY FOR A GENERATOR THAT WAS ANALYZED, IT WAS OBSERVED THAT DURING INTERROGATION ON OFFICE VISIT ON (B)(6) 2013 THE PATIENT'S SETTINGS WERE DIFFERENT THAN WHAT WERE PROGRAMMED AT THE SAME OFFICE VISIT. THE SETTINGS FOUND WERE INDICATIVE OF A FAULTED DIAGNOSTIC TEST WHICH OCCURRED ON 11/02/2013. THE DEVICE WAS INTERROGATED PRIOR TO THE PATIENT LEAVING THE OFFICE ON (B)(6) 2013 AS RECOMMENDED BY DEVICE MANUFACTURER TO ENSURE THE DEVICE IS AT THE CORRECT SETTINGS; HOWEVER, THE PHYSICIAN DID NOT CORRECT THE SETTINGS. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406095 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 1073773

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR