BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 5067956 · Received September 10, 2015

    Report

    Report Number
    1644487-2015-05746
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 19, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE UDI: (B)(4). THE SUSPECT MEDICAL DEVICE UDI: (B)(4). THIS INFORMATION WAS INADVERTENTLY LEFT OFF ON MFG. REPORT #0.

    Description of Event or Problem · 1

    ANALYSIS OF THE USB CABLE WAS COMPLETED ON 09/16/2015. THE CAUSE FOR THE REPORTED ALLEGATION IS ASSOCIATED WITH TWO DISCONNECTED WIRE CONNECTIONS IN THE RETURNED SERIAL CABLE. ONCE THE WIRES WERE SOLDERED ONTO THE SERIAL CABLE PCB, NO FURTHER ANOMALIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S TABLET WAS HAVING CONTINUOUS FAILURE TO COMMUNICATE MESSAGES. TROUBLESHOOTING WAS PERFORMED BY ENSURING THE WAND BATTERY WAS FULLY FUNCTIONAL. THE COMPANY REPRESENTATIVE USED HER WAND ON THE PHYSICIAN'S USB CABLE AND PROGRAMMING TABLET AND NO COMMUNICATION WAS OBTAINED. THE COMPANY REPRESENTATIVE THEN TRIED THE PHYSICIAN'S WAND AND TABLET WITH HER USB CABLE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE COMPANY REPRESENTATIVE THEN TRIED HER ENTIRE PROGRAMMING SYSTEM WHICH DID NOT WORK (MFR. REPORT # 1644487-2015-05747). A NEW USB CABLE WAS USED WITH THE PHYSICIAN'S TABLET AND WAND WHICH RESOLVED THE ISSUE. THE FAULTY USB CABLE WAS RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600325 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1