BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1970063 · Received January 14, 2011

    Report

    Report Number
    1644487-2011-00071
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING THE REVIEW OF THE PATIENT'S SETTINGS AT THE TIME OF EXPLANT, THAT THEY WERE SET TO SETTINGS THAT LIKELY OCCURRED DUE TO AN INTERRUPTION IN A SYSTEM DIAGNOSTIC TEST. IT IS UNCLEAR IF THE EVENT OCCURRED AT THE TIME OF EXPLANT OR PRIOR. NO FURTHER DETAILS HAVE BEEN MADE AVAILABLE TO DATE ON THE SPECIFIC PROGRAMMING OR PHYSICIAN INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR