BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2102253 · Received May 19, 2011

    Report

    Report Number
    1644487-2011-01144
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES WITH AN UNKNOWN RELATIONSHIP TO THE PRE-VNS BASELINE AND WAS EXPERIENCING PAINFUL STIMULATION UNDERNEATH HIS ARMPIT. DIAGNOSTICS TAKEN INDICATED NORMAL DEVICE FUNCTION; HOWEVER, THE GENERATOR WAS AT OR NEAR END OF SERVICE. A ROUGH BATTERY LIFE CALCULATION WAS PERFORMED USING DATES FROM 10/09/2002 TO 12/27/2006 THAT CONFIRMED THAT THE GENERATOR WAS LIKELY AT END OF SERVICE. UPON INTERROGATION OF THE PATIENT'S VNS, IT WAS FOUND THAT A FAULTED DIAGNOSTICS TEST HAD LIKELY OCCURRED, RESULTING IN A CHANGE IN THE PATIENT'S SETTINGS. THE PHYSICIAN INDICATED THAT THE INCREASE IN SEIZURES WAS LIKELY A RESULT OF THE DECREASE IN SETTINGS. THE PATIENT'S GENERATOR HAS BEEN REPLACED DUE TO END OF SERVICE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 855099

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention