BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2922560 · Received January 18, 2013

    Report

    Report Number
    1644487-2013-00191
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    September 1, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ANALYSIS OF THE VNS COMPUTER AND WAND WAS COMPLETED. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD COMPUTER WAS UNABLE TO ADVANCE PAST THE SCREEN ALIGNMENT UTILITY. THE CAUSE FOR THE DISPLAY ANOMALY IS ASSOCIATED WITH RESISTANCE VALUES BEING HIGHER THAN EXPECTED IN THE TOUCH SCREEN CIRCUITRY. CONTINUITY TESTING OF THE RETURNED DISPLAY IDENTIFIED AN ANOMALY ASSOCIATED WITH THE TRACE THAT IS ROUTED TO PIN 4 OF THE TOUCH SCREEN FLEX CABLE. RESISTANCE READINGS ASSOCIATED WITH THE CIRCUIT WERE HIGHER THAN EXPECTED (READ APPROXIMATELY 57M OHMS FOR PIN 4 - NOMINAL IS APPROXIMATELY .418K OHMS). PRESSED ON THE FLEX CABLE WHERE IT ATTACHES TO THE TOUCH SCREEN AND IT WAS IDENTIFIED THAT THE RESISTANCE READING WAS STILL SIGNIFICANTLY HIGHER THAN EXPECTED. ONCE THE DISPLAY WAS REPLACED WITH A KNOWN GOOD DISPLAY, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD COMPUTER PERFORMANCE WERE IDENTIFIED DURING THE ANALYSIS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS

    Description of Event or Problem · 1

    REPORTER INDICATED VNS PROGRAMMING SYSTEM WAS HAVING INTERMITTENT COMMUNICATION ISSUES SINCE (B)(6) 2012, AND NOW WAS NOT COMMUNICATING AT ALL. IT WAS LATER REPORTED THAT THE COMPUTER SCREEN WOULD NOT ADVANCE PAST THE ALIGN SCREEN SINCE THE LATEST CYBERONICS SOFTWARE UPGRADE FROM VERSION (B)(4). CLEANING THE SCREEN DID NOT RESOLVE THE ISSUE AND THE SCREEN WOULD STILL NOT ADVANCE PAST THE ALIGN SCREEN. THE PROGRAMMING WAND WAS CONFIRMED TO BE PERFORMING AS INTENDED WITH A DIFFERENT VNS COMPUTER. THE COMPUTER AND FLASHCARD WERE RECEIVED ON 01/09/2013 AND ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28042 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075844

    Patients

    Seq Age Sex Outcome Treatment
    1