BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2183309 · Received July 28, 2011

    Report

    Report Number
    1644487-2011-01691
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    April 20, 2006
    Report Date
    July 8, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED DIFFERENT SETTINGS THEN WHAT WAS INTENDED AT THE FIRST FOLLOW-UP APPOINTMENT POST DEVICE IMPLANT. THE PATIENT'S PROGRAMMING HISTORY AVAILABLE IN THE IN-HOUSE DATABASE WAS REVEALED AND IT WAS FOUND THAT A FAULTED SYSTEMS DIAGNOSTIC TEST OCCURRED ON THE DATE OF IMPLANT WHICH CHANGED THE PATIENT'S SETTINGS. THE ERROR WAS NOT OBSERVED UNTIL THE FIRST FOLLOW UP APPOINTMENT AT WHICH TIME THE SETTINGS WERE ADJUSTED. THE OFF TIME WAS NOT CORRECTED UNTIL APPROXIMATELY 1 MONTH POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE MUZ CYBERONICS INC MODEL 250 250606

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR