BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3070697 · Received April 22, 2013

    Report

    Report Number
    1644487-2013-01104
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    REPORTER INDICATED A VNS (B)(4) COMPUTER HAD A LOOSE SERIAL CABLE CONNECTION AND WAS CAUSING INTERMITTENT COMMUNICATION ISSUES. THE ISSUE APPEARS TO BE WITH THE HOUSING IN THE COMPUTER (PORT), AND IN ORDER TO MAKE THE CONNECTION, ONE HAS TO "PUSH" THE SERIAL CABLE IN. ATTEMPTS FOR RETURN OF THE COMPUTER FOR PRODUCT ANALYSIS ARE IN PROGRESS.

    Description of Event or Problem · 1

    THE VNS COMPUTER AND FLASHCARD WERE RETURNED FOR ANALYSIS ON (B)(6) 2013. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD COMPUTER WAS UNABLE TO ESTABLISH COMMUNICATION WITH A KNOWN GOOD WAND AND GENERATOR. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH 2 BROKEN WIRE CONNECTIONS IN THE SERIAL CABLE. ONCE THE WIRES WERE SOLDERED ONTO THE SERIAL CABLE PCB, NO FURTHER ANOMALIES WERE IDENTIFIED. THE BROKEN WIRES ARE LIKELY DUE TO MECHANICAL STRESS AND WEAR. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172165 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS INC MODEL 250 840143

    Patients

    Seq Age Sex Outcome Treatment
    1