BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1910056 · Received November 10, 2010

    Report

    Report Number
    1644487-2010-02524
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PT'S DEVICE WAS FOUND TO BE SET TO 0 MA DURING A ROUTINE OFFICE VISIT. THE NURSE PRACTITIONER STATED THAT SHE DID NOT KNOW WHEN THE DEVICE WAS SET TO 0 MA. SHE MADE SEVERAL ATTEMPTS TO RE-PROGRAM THE PT'S DEVICE BUT EACH SUBSEQUENT INTERROGATION SHOWED THAT THE PT WAS STILL SET AT 0 MA. THE NP ALSO STATED THAT THE PT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURES AND THE PT'S MOTHER DOES NOT FEEL AS THOUGH THE DEVICE IS WORKING. THE NP INDICATED THAT SHE BELIEVED THE DEVICE MAY BE AT END OF SERVICE AND THE PT WAS REFERRED FOR REVISION SURGERY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO ARE CURRENTLY BEING MADE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR