BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 6168122 · Received December 12, 2016

    Report

    Report Number
    1644487-2016-02842
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT HE WAS HAVING DIFFICULTY COMMUNICATING WITH A PATIENT¿S GENERATOR AT THE BEGINNING OF A SURGERY. IT WAS DETERMINED TO BE AN ISSUE WITH THE WHITE USB SERIAL DATA CABLE. THE PROGRAMMING TABLET WAS BEING HELD UP BY A MAYO STAND AND THE CABLE WAS HANGING FROM THE TABLET OVER THE EDGE OF THE MAYO STAND. THE WAND WAS HELD FAR ENOUGH AWAY TO WHERE THE CONNECTION CABLE WAS TAUT. THE TABLET WAS MOVED FURTHER UP THE MAYO STAND SUCH THAT THE CABLE WAS SUPPORTED AND THE ISSUE RESOLVED AT THAT TIME, HOWEVER THE ISSUE PERSISTED AFTER THAT SURGERY. THE WHITE USB SERIAL DATA CABLE WAS REPLACED WITH A NEW BLACK USB SERIAL DATA CABLE AND THE PROBLEM WAS REPORTED TO HAVE BEEN RESOLVED. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO-DATE. THE SERIAL CABLE DOES NOT REQUIRE RETURN, AS THE FAILURE MODE IS UNDERSTOOD TO BE A FAILURE OF THE SERIAL CABLE ASSOCIATED WITH A DISCONNECTED WIRE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818406 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS - HOUSTON MODEL 250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1