BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3202836 · Received July 2, 2013

    Report

    Report Number
    1644487-2013-02024
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    November 2, 2006
    Report Date
    June 25, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF PROGRAMMING HISTORY, IT WAS NOTED THAT THIS DEVICE WAS INTERROGATED AT SETTINGS INDICATIVE OF A FAULTED TEST. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS. IT IS LIKELY THAT THE EVENT OCCURRED ON THE DATE OF GENERATOR IMPLANT ((B)(6) 2006); HOWEVER, NO HISTORY IS AVAILABLE FROM THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302069 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR