BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2810002 · Received October 31, 2012

    Report

    Report Number
    1644487-2012-02808
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    January 1, 1994
    Report Date
    October 3, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 WHEN THE PHYSICIAN REPORTED THAT HE WAS UNWILLING TO PROVIDE FURTHER INFORMATION REGARDING THE PATIENTS MENTIONED IN THE POSTER.

    Description of Event or Problem · 1

    A POSTER OF AN ARTICLE TITLED "SURGICAL AND HARDWARE COMPLICATIONS TO VAGAL NERVE STIMULATION FOR DRUG-RESISTANT EPILEPSY. A (B)(4) STUDY OF (B)(4) PATIENTS". WAS RECEIVED ON (B)(6) 2012. THIS STUDY LOOKED AT PATIENTS TREATED WITH VNS FOR DRUG-RESISTANT EPILEPSY BETWEEN 1994 - (B)(6) 2010. ALL PATIENTS HAD BEEN WORKED UP WITHIN THE EPILEPSY-SURGERY PROGRAM AND FOUND NOT SUITABLE FOR RESECTIVE EPILEPSY SURGERY OR FAILURES THEREOF. TWO WEEKS POST IMPLANTATION THE STIMULATION WAS TURNED ON AND RAMPED UP, DURING APPROXIMATELY THREE DAYS, AIMING AT AN INITIAL STIMULATION CURRENT OF 1.25 MA. THE PATIENTS WERE FOLLOWED DURING THE FIRST YEAR OF STIMULATION WITH REGULAR ASSESSMENTS EVERY THREE MONTHS IN OUR OUTPATIENT CLINIC. DURING THE FOLLOWING YEARS THE PATIENTS WERE SEEN AT LEAST ONCE YEARLY FOR CLINICAL ASSESSMENTS, INCLUDING AN EVALUATION OF THE FUNCTION OF THE VNS-DEVICE AND AN ESTIMATION OF THE LIFE EXPECTANCY OF THE BATTERY. THIS REPORT ADDRESSES THE SEVENTH OF THE EIGHT VOCAL CORD PALSY EVENTS LISTED IN THE POSTER. THE VOCAL CORD PALSY OCCURRED POST FIRST INSERTION. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1