BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2910483 · Received January 11, 2013

    Report

    Report Number
    1644487-2013-00126
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    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
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PATIENT'S VNS SETTINGS WERE NOTED TO HAVE "RESET" ON (B)(6) 2012 FOLLOWING A VNS DIAGNOSTICS TEST. IT IS UNCLEAR IF THE "RESET" OCCURRED DURING THE OFFICE VISIT OR AT AN EARLIER DATE. ATTEMPTS FOR FURTHER INFORMATION AND VNS PROGRAMMING HISTORY ARE IN PROGRESS.

    Description of Event or Problem · 1

    ALL ATTEMPTS TO THE REPORTER FOR ADDITIONAL INFORMATION AND VNS PROGRAMMING HISTORY HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18308 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR