BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1872494 · Received October 12, 2010

    Report

    Report Number
    1644487-2010-02280
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE, THAT WHEN THE VNS PT WAS SEEN FOR A ROUTINE F/U APPOINTMENT, AND WHEN A SYSTEM DIAGNOSTIC TEST WAS PERFORMED, THE RESULTS REVEALED HIGH LEAD IMPEDANCE, LEAD IMPEDANCE>=10,000 OHMS. THE DEVICE WAS PROGRAMMED OFF AS INTERVENTION. THERE WAS NOTE THAT THE PT MAY HAVE EXPERIENCED A FALL RECENTLY. THE NURSE STATED THAT THE PT WAS INITIALLY THOUGHT TO BE A NON-RESPONDER TO VNS THERAPY FOR SEIZURE CONTROL, HOWEVER, ADD'L INFO RECEIVED REVEALED THAT SINCE THE DEVICE HAS BEEN DISABLED, THE PT HAS HAD A RESURGENCE OF COMPLEX PARTIAL SEIZURES AND HIS SLEEP HAS BEEN MORE DISTURBED. THE PT HAS EXPERIENCED A RECENT CHANGE IN THE LIVING SITUATION AND THE CAUSE OF THE INCREASE IN SEIZURES IS UNK AT THIS TIME, AS THERE MAY BE OTHER FACTORS INVOLVED. X-RAYS HAVE BEEN TAKEN AND PER THE RADIOLOGIST'S ASSESSMENT, THERE WERE NO LEAD DISCONTINUITIES OBSERVED. ATTEMPTS TO OBTAIN THE X-RAY IMAGES FOR REVIEW ARE IN PROGRESS. THE PT WILL LIKELY BE REFERRED TO A SURGEON TO FURTHER EXPLORE THE CAUSE OF THE HIGH LEAD IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 2224

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR