BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2102227 · Received May 19, 2011

    Report

    Report Number
    1644487-2011-01117
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 3, 2010
    Report Date
    April 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ANALYSIS OF PROGRAMMING HISTORY (IF APPLICABLE).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PATIENT WAS HAVING PAINFUL STIMULATION, ALTHOUGH THE PAIN WAS NOT PRESENT WITH EVERY STIMULATION. SYSTEM DIAGNOSTICS REVEALED PROPER DEVICE FUNCTION AT THIS TIME AND THE PATIENT'S SETTINGS WERE SAID TO BE 2 MA/20 HZ/250 MICROSEC/30 SEC/5 MIN. FURTHERMORE, WHEN A COMPANY REPRESENTATIVE FOLLOWED UP WITH THE SITE DIAGNOSTICS ON (B)(6) 2010 SHOWED ALL SYSTEMS TO BE PROPERLY FUNCTIONING. IT WAS ON THIS DATE THAT THE DOCTOR DESCRIBED RECEIVING AN ERROR MESSAGE, BUT THE EXACT DETAIL ON THE MESSAGE WAS NOT KNOWN AT THIS TIME. THE REPRESENTATIVE MET WITH THE PATIENT AND DOCTOR AND FOUND THE PATIENT'S SETTINGS TO BE 1 MA/20 HZ/500 MICROSEC/30 SEC/60MIN. SYSTEM DIAGNOSTIC TESTING ON THIS DAY SHOWED PROPER DEVICE FUNCTION. IT WAS EXPLAINED TO THE DOCTOR THAT THESE SETTINGS INDICATED A FAULTED DIAGNOSTIC TEST. ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    A REVIEW OF THE PATIENT'S PROGRAMMING HISTORY WAS PERFORMED ON (B)(6) 2012. DURING THIS REVIEW IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTIC TEST FIRST OCCURRED ON (B)(6) 2010, WHICH RESULTED IN A CHANGE TO THE PATIENT'S SETTINGS. THE OFF TIME WAS LEFT AT 60 MINUTES AND THE MAGNET WAS LEFT AT 1.0MA. IT WAS PREVIOUSLY REPORTED BY THE PHYSICIAN THAT ON (B)(6) 2010, THE PATIENT'S OFF TIME WAS 5 MINUTES, HOWEVER REVIEW OF THE AVAILABLE HISTORY INDICATES THAT THE OFF TIME WAS 60 MINUTES AS IT HAD NOT PREVIOUSLY BEEN CORRECTED. ADDITIONALLY 3 FAULTED TEST OCCURRED ON (B)(6) 2011, WHICH RESULTED IN A CHANGE TO THE PATIENT'S SETTING. AGAIN, THE PATIENT LEFT AT UN-INTENDED SETTINGS AS THE OFF TIME WAS LEFT AT 60MINUTES. THE OFF TIME WAS NOT CORRECTED UNTIL (B)(6) 2011. THE MAGNET APPEARS TO HAVE BEEN INTENTIONALLY ENABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 678298

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR