BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2915667 · Received January 15, 2013

    Report

    Report Number
    1644487-2013-00151
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 FLASHCARD WAS COMPLETED. NO SOFTWARE ANOMALIES WERE IDENTIFIED DURING THE ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE COMPUTER WAS UNABLE TO ESTABLISH COMMUNICATION WITH A KNOWN GOOD WAND AND GENERATOR. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH A BROKEN WIRE CONNECTION IN THE SERIAL CABLE. ONCE THE WIRE WAS SOLDERED ONTO THE SERIAL CABLE PCB, NO FURTHER ANOMALIES WERE IDENTIFIED. 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

    THE VNS COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE PENDING ANALYSIS.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT'S VNS GENERATOR WAS NOT ABLE TO BE INTERROGATED WITH A VNS PROGRAMMING SYSTEM. A NEW VNS COMPUTER WAS ATTACHED TO THE EXISTING PROGRAMMING WAND AND THE PATIENT WAS ABLE TO BE SUCCESSFULLY INTERROGATED AT A LATER DATE. IT IS SUSPECTED THE VNS COMPUTER MAY BE FAULTY. ATTEMPTS FOR PRODUCT RETURN ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21685 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER MUZ CYBERONICS, INC. MODEL 250 1075840

    Patients

    Seq Age Sex Outcome Treatment
    1