BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2893173 · Received January 2, 2013

    Report

    Report Number
    1644487-2013-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    October 15, 2012
    Report Date
    December 4, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED MDR INADVERTENTLY OMITTED THE GENERATOR SETTINGS ON (B)(6) 2012. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Additional Manufacturer Narrative · 1

    INTERROGATION OF DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS VNS PATIENT UNDERWENT LEAD REVISION (CAPTURED IN MFR REPORT # 1644487-2012-02986. THE PATIENT'S GENERATOR WAS LEFT AT THE SETTINGS HE CAME IN TO THE OPERATING ROOM WITH. THESE SETTINGS ARE INDICATIVE OF A FAULTED SYSTEM DIAGNOSTIC TEST. FOLLOW-UP SHOWED THAT A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON THE DATE OF GENERATOR REVISION. (GENERATOR REVISION IS CAPTURED IN MFR REPORT # 1644487-2012-02528.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1050823

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR