BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2201277 · Received August 3, 2011

    Report

    Report Number
    1644487-2011-01759
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS SEEN IN CLINIC AND HIGH IMPEDANCE WAS OBSERVED ON BOTH NORMAL AND SYSTEM MODE DIAGNOSTICS. THE PT CALLED THE OFFICE THE DAY BEFORE, STATING THAT HE COULD NO LONGER FEEL STIMULATION, AND THAT IT HAD BEEN OCCURING FOR ABOUT TWO WEEKS. THE PT ALSO NOTED A RECENT INCREASE IN SEIZURES REPORTEDLY ABOVE BASELINE OCCURING OVER THE LAST TWO MONTHS. THE PT WAS LAST SEEN IN (B)(6) AND, AT THAT TIME, THE IMPEDANCE WAS WITHIN NORMAL LIMITS. THE PT WAS PROGRAMMED OFF, AND REFERRED FOR REPLACEMENT. THE PT'S LEAD AND GENERATOR HAVE SINCE BEEN EXPLANTED AND REPLACED. THE PRODUCTS HAVE NOT YET BEEN RETURNED TO THE MFR FOR PRODUCT ANALYSIS. THE PT'S PHYSICIAN ATTRIBUTES THE INCREASE IN SEIZURES AND THE FAILURE TO PERCEIVE STIMULATION TO THE HIGH IMPEDANCE, AND INDICATED THAT THE PT HAS DONE VERY WELL WITH VNS THERAPY. NO ADD'L INFO HAS BEEN MADE AVAILABLE, AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30 11003

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention