BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4892758 · Received July 6, 2015

    Report

    Report Number
    1644487-2015-05090
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Report Date
    June 10, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN'S PROGRAMMER DATA WAS COPIED AND RECEIVED BY THE MANUFACTURER. HOWEVER, THE RECEIVED COPIED DATA DOES NOT PROVIDE ADDITIONAL PROGRAMMING DATA FOR THIS PATIENT'S GENERATOR.

    Description of Event or Problem · 1

    A COMPUTER SOFTWARE ERROR HAS BEEN VERIFIED, ON (B)(6) 2015 FOR THE PATIENT¿S MODEL 102 GENERATOR FROM A REVIEW OF THE APRIL PROGRAMMING HISTORY DATABASE SPREADSHEET AND PERIODIC REVIEW ALGORITHM. ON (B)(6) 2007 THE DEVICE WAS INTERROGATED THEN PROGRAMMED, THEN A SYSTEM DIAGNOSTIC WAS PERFORMED. AFTER THE SYSTEM DIAGNOSTIC THE DEVICE WAS INTERROGATED, PROGRAMMED AND A FINAL INTERROGATION THE SETTINGS WERE AS INTENDED. THERE IS NO EVIDENCE OF A "FAULTED" DIAGNOSTIC OR COMMUNICATION INTERRUPTION DURING THIS VISIT. ON THE NEXT RECORDED VISIT (B)(6) 2014 THE FIRST INTERROGATION THE SETTINGS WERE INDICATIVE OF A "FAULTED" DIAGNOSTIC. THERE IS APPROXIMATELY 7 YEARS OF MISSING PROGRAMMING HISTORY AND THE DATE OF THE "FAULTED" DIAGNOSTIC IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436769 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1