BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNS LEAD

    MDR report key: 2150756 · Received July 3, 2011

    Report

    Report Number
    2150756
    Event Type
    Malfunction
    Date Received
    July 3, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 3, 2011
    Manufacturer
    CYBERONICS
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT IMPLANTATION OF HER VAGUS NERVE STIMULATOR (VNS) ~3 YEARS AGO. INITIALLY, IT WORKED WELL TO REDUCE THE FREQUENCY AND SEVERITY OF PATIENT SEIZURES. PATIENT WAS ABLE TO USE THE DEVICE TO HELP ABORT HER SEIZURES. PATIENT IS NOW HAVING EVENTS 1-2 TIMES A WEEK. SHE HAS BEGUN TO EXPERIENCE AURAS AGAIN. INTERROGATION OF HER VNS INDICATES HIGH IMPEDANCE, SUGGESTING A MALFUNCTION. CHEST XRAY PERFORMED AND SUSPECT THE LOWER CONTACT ON THE NERVE MAY BE FRACTURED. THE CONTACT IS SITTING AT AN ODD ANGLE ON THE NERVE, AND DOES NOT SEEM TO BE WINDING AROUND THE NERVE THE WAY IT SHOULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW CYBERONICS 302-20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR