BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 6012921 · Received October 7, 2016

    Report

    Report Number
    1644487-2016-02293
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 12, 2016
    Report Date
    August 7, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INADVERTENTLY NOT PROVIDED ON FOLLOW-UP REPORT #4 THAT THE PROGRAMMING WAND ALSO HAD BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION, CORRECTED DATA: PART OF THE EVENT DESCRIPTION INFORMATION WAS INADVERTENTLY NOT PROVIDED IN THE INITIAL REPORT. BRAND NAME, CORRECTED DATA: THE BRAND NAME OF THE SUSPECT DEVICE WAS INADVERTENTLY PROVIDED INCORRECTLY IN THE INITIAL REPORT. TYPE OF DEVICE, CORRECTED DATA: THE TYPE OF DEVICE OF THE SUSPECT DEVICE WAS INADVERTENTLY PROVIDED INCORRECTLY IN THE INITIAL REPORT. MODEL #, CORRECTED DATA: THE MODEL NUMBER OF THE SUSPECT DEVICE WAS INADVERTENTLY PROVIDED INCORRECTLY IN THE INITIAL REPORT.

    Description of Event or Problem · 1

    FOLLOW-UP FROM THE PHYSICIAN PROVIDED THAT THE SCREEN FREEZES AND THAT COMMUNICATION DOES NOT HAPPEN UNTIL THE CABLE IS MOVED AROUND.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN THAT A HANDHELD PROGRAMMER WAS GIVING HIM TROUBLE UPON INTERROGATION. HE STATED THAT THE SCREEN WOULD FREEZE ON THE DEVICE. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO-DATE.

    Description of Event or Problem · 1

    THE HANDHELD AND SOFTWARE WERE RECEIVED BY THE MANUFACTURER. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO-DATE.

    Description of Event or Problem · 1

    THE PROGRAMMING WAND WAS RECEIVED FOR ANALYSIS. ANALYSIS WAS COMPLETED FOR THE HANDHELD AND FLASHCARD AND WAND. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE PROGRAMMING WAND ANALYSIS SHOWED THE SERIAL DATA CABLE PRODUCED COMMUNICATION ERRORS AND HAD INTERMITTENT CONDUCTORS AT THE HANDLE LOCATION. A KNOWN GOOD BENCH SERIAL DATA CABLE WAS SUBSTITUTED AND ALL COMMUNICATIONS ERRORS CLEARED. CONTINUITY TESTING OF THE BATTERY CABLE PASSED. AFTER THE SERIAL DATA CABLE WAS SUBSTITUTED, THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    FOLLOW-UP FROM THE PHYSICIAN PROVIDED THAT COMMUNICATION ERRORS OCCURRED INTERMITTENTLY, BUT COULD BE RESOLVED WITH DIFFICULTY BY MANIPULATING THE WAND CABLE. HOWEVER, SOMETIMES DURING THE COMMUNICATION THE SCREENS WOULD FREEZE DURING THE ATTEMPTS TO INTERROGATE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE SCREEN WOULD FREEZE AND HE OFTEN WOULD NEED TO MOVE THE WAND CABLE FOR IT TO TRANSMIT, INDICATING THE PROGRAMMING WAND AS THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662205 PROGRAMMING WAND PROGRAMMING WAND MUZ CYBERONICS, INC. 201 NI

    Patients

    Seq Age Sex Outcome Treatment
    1