BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2446372 · Received February 10, 2012

    Report

    Report Number
    1644487-2012-00352
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    July 7, 2011
    Report Date
    January 11, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ADDITIONAL PROGRAMMING HISTORY WAS RECEIVED FROM THE PHYSICIAN'S OFFICE INDICATING THAT A FAULTED DIAGNOSTICS TEST OCCURRED ON (B)(6) 2011, THAT RESULTED IN THE SETTINGS AS INDICATED BY THE PHYSICIAN. A FINAL INTERROGATION WAS NOT PERFORMED TO VERIFY THAT THE PATIENT WAS AT THE INTENDED SETTINGS. THE SETTINGS WERE NOT CORRECTED UNTIL THE DATE OF THE REPORT BY THE PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT UPON INTERROGATION, THE PATIENT'S VNS SETTINGS WERE INDICATIVE THAT A FAULTED DIAGNOSTIC TEST HAD OCCURRED. IT WAS UNKNOWN IF THE FAULT OCCURRED DURING PROGRAMMING EARLIER THAT DAY OR AT THE PREVIOUS OFFICE VISIT. THE SETTINGS WERE CORRECTED AT THE TIME OF DISCOVERY. NO ADVERSE EVENTS ARE BELIEVED TO HAVE OCCURRED AS A RESULT OF THE CHANGE IN SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. MODEL 250 842377

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR