BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4051520 · Received September 2, 2014

    Report

    Report Number
    1644487-2014-02143
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    September 12, 2003
    Report Date
    August 8, 2014
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS OBSERVED THAT INITIAL INTERROGATION ON (B)(6) 2003 RESULTED IN SETTINGS THAT WERE INDICATIVE OF A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRING. THERE IS NO PROGRAMMING OR DIAGNOSTIC HISTORY FROM DATE OF IMPLANT OF THE PATIENT¿S GENERATOR ((B)(6) 2003) THROUGH (B)(6) 2003. THE PHYSICIAN CORRECTED THE SETTINGS ON THE CLINIC VISIT ON (B)(6) 2003. IT APPEARS LIKELY THAT THE FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON DATE OF IMPLANT, BUT THIS CANNOT BE CONFIRMED. THE DEVICE MANUFACTURER RECOMMENDS TO KEEP THE DEVICE PROGRAMMED OFF (AS THE DEVICE WAS FOUND ON (B)(6) 2003) FOR A COUPLE WEEKS AFTER IMPLANT. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533341 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR