BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2993677 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00638
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INTERROGATED ON (B)(6) 2012 AND THEN SYSTEM AND NORMAL MODE DIAGNOSTIC TESTS WERE PERFORMED WERE RAN ALONG WITH A FINAL INTERROGATION. THE NEXT DAY, THE PATIENT CALLED THE PHYSICIAN'S OFFICE SEVERE PAIN. ON (B)(6) 2012, THE PATIENT PRESENTED BACK TO THE OFFICE AND HER DEVICE WAS INTERROGATED AND FOUND TO BE AT UNINTENDED PARAMETERS THAT WERE INDICATIVE OF A FAULTED SYSTEM DIAGNOSTIC TEST. THE NURSE PRACTITIONER PROGRAMMED THE PATIENT'S PARAMETERS BACK TO NORMAL, AND THE PATIENT WAS REPORTEDLY OKAY. THE COMPANY REPRESENTATIVE CONFIRMED THAT THE FAULTED SYSTEM DIAGNOSTIC TEST ON (B)(6) 2012 RESULTED IN THE PROGRAMMING ANOMALY. THE REPRESENTATIVE CONFIRMED THAT THE FINAL INTERROGATION ON (B)(6) 2012 SHOWED THE UNINTENDED SETTINGS BUT THEY WERE NOT CORRECTED UNTIL (B)(6) 2012. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN'S OFFICE INDICATING THE PATIENT'S PAIN WAS IN THE LEFT NECK REGION NEAR THE VAGUS NERVE AND WAS ASSOCIATED WITH VNS STIMULATION ON TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98325 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1075378

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR