BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3193066 · Received June 27, 2013

    Report

    Report Number
    1644487-2013-01949
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    January 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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Additional Manufacturer Narrative · 1

    THE INCORRECT DATE WAS INADVERTENTLY LISTED ON THE INITIAL REPORT. THE DATE OF THE REPORT WAS (B)(4) 2013 THE SAME DATE AS IN MANUFACTURER REPORT NUMBER 1644487-2013-01957. THE INFORMATION SUBMITTED ON THE INITIAL REPORT WAS INADVERTENTLY SENT, AS IT IS DUPLICATE INFORMATION TO THAT WHICH WAS REPORTED IN MANUFACTURER REPORT NUMBER 1644487-2013-01957. THE INCORRECT AWARE DATE WAS INADVERTENTLY LISTED ON THE INITIAL REPORT. THE AWARE DATE SHOULD HAVE BEEN (B)(4) 2013, THE SAME AWARE DATE AS IN MANUFACTURER REPORT NUMBER 1644487-2013-01957.

    Description of Event or Problem · 1

    THE PATIENT'S VNS GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS AFTER BEING EXPLANTED DUE TO THE DEVICE NEARING BATTERY DEPLETION. UPON RECEIPT OF THE DEVICE, IT WAS NOTED THAT THE SETTINGS WERE INDICATIVE OF A FAULTED DIAGNOSTIC TEST. FOLLOW UP WAS PERFORMED WITH THE SITE TO SEE IF THEY HAD THE PATIENT'S SETTINGS OR DIAGNOSTIC HISTORY PRIOR TO THE EXPLANT SURGERY; HOWEVER, THIS INFORMATION WAS UNAVAILABLE. NO INFORMATION WAS PROVIDED. A REVIEW OF PROGRAMMING HISTORY FOUND DATA UP TO THE YEAR 2010. IT IS UNKNOWN IF AND WHEN A FAULTED DIAGNOSTIC TEST MAY HAVE OCCURRED. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293394 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1