BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3913621 · Received July 3, 2014

    Report

    Report Number
    1644487-2014-01693
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR OMITTED THAT THE NEW SERIAL CABLE DID NOT RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE COMMUNICATION ISSUES WITH THE PROGRAMMING SYSTEM. THE WAND BATTERY WAS REPLACED AND THE HANDHELD WAS UNPLUGGED FROM THE WALL SOCKET. THE COMMUNICATION ISSUES RESOLVED WHEN THE SERIAL CABLE WAS HELD IN A SPECIFIC ORIENTATION. THE HANDHELD SERIAL CABLE HAS NOT BEEN RETURNED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PRODUCTS ARE NOT EXPECTED FOR RETURN AS THEY ARE BELIEVED TO BE LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391076 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 840143

    Patients

    Seq Age Sex Outcome Treatment
    1