BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 4120158 · Received September 25, 2014

    Report

    Report Number
    1644487-2014-02486
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROGRAMMING TABLET AND WAND WERE RECEIVED FOR ANALYSIS. ANALYSIS ON THE PROGRAMMING WAND WAS COMPLETED. ANALYSIS SHOWED THAT THE WAND FAILED TO COMMUNICATE DURING FUNCTIONAL TESTING. THE SERIAL DATA CABLE, WHICH PRODUCED COMMUNICATION ERRORS, 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. ANALYSIS OF THE RETURNED TABLET REVEALED NO OBSERVED ANOMALIES; THE TABLET PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPANY REPRESENTATIVE'S PROGRAMMING TABLET WAS UNABLE TO INTERROGATE TWO DIFFERENT GENERATORS. IT WAS REPORTED THAT A COMMUNICATION ERROR MESSAGE WAS OBSERVED. IT WAS REPORTED THAT THE TABLET WAS NOT PLUGGED INTO AN ELECTRICAL OUTLET AND THE WAND BATTERY WAS WORKING. A KNOWN GOOD WAND WAS EXCHANGED AND THE COMMUNICATION ERROR CONTINUED. A KNOWN GOOD USB CABLE WAS USED AND THE TABLET WOULD STILL NOT INTERROGATE THE GENERATORS. THE COMPANY REPRESENTATIVE WAS PROVIDED A NEW PROGRAMMING TABLET. THE NONFUNCTIONAL TABLET IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMING TABLET IS UNABLE TO BE LOCATED. THE TABLET HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599037 PROGRAMMING WAND PROGRAMMING WAND LYJ CYBERONICS, INC. 201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1