BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3071535 · Received April 22, 2013

    Report

    Report Number
    1644487-2013-01115
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 21, 2011
    Report Date
    March 25, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS OBSERVED THAT DURING INTERROGATION ON OFFICE VISIT ON (B)(6) 2011 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 (B)(6) 2011. THE PHYSICIAN CORRECTED THE SETTINGS; HOWEVER, THE DEVICE OFF TIME AND FREQUENCY WERE NOT CORRECTED. THE DEVICE WAS INTERROGATED PRIOR TO THE PATIENT LEAVING THE OFFICE ON (B)(6) 2011 AS RECOMMENDED BY DEVICE MANUFACTURER TO ENSURE THE DEVICE IS AT THE CORRECT SETTINGS; HOWEVER, THE PHYSICIAN DID NOT CORRECT THE OFF TIME BACK TO EFFICACIOUS SETTING. THE SETTING WAS CORRECTED ON (B)(6) 2012. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172181 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 857133

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR