BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1585689 · Received January 20, 2010

    Report

    Report Number
    1644487-2010-00140
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    January 1, 2006
    Report Date
    December 21, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: BENIFLA M, RUTKA JT, LOGAN W, ET AL. VAGAL NERVE STIMULATION FOR REFRACTORY EPILEPSY IN CHILDREN: INDICATIONS AND EXPERIENCE AT THE HOSPITAL FOR SICK CHILDREN. CHILDS NERV SYST 2006; 22:1018-26.

    Description of Event or Problem · 1

    DURING THE REVIEW OF AN ARTICLE TITLED "VAGAL NERVE STIMULATION FOR REFRACTORY EPILEPSY IN CHILDREN: INDICATIONS AND EXPERIENCE AT THE HOSPITAL FOR SICK CHILDREN", IT WAS NOTED THAT THE VNS PT'S DEVICE WAS REPLACED DUE TO ELECTRODE FAILURE AFTER 3.5 YEARS. IT IS UNK AT THIS TIME HOW THIS LEAD FAILURE WAS DIAGNOSED. IT IS UNK IF THERE WAS ANY PT MANIPULATION OR TRAUMA TO THE DEVICE SITE THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO FROM THE PRIMARY AUTHORS HAVE BEEN MADE, BUT NO ADD'L INFO HAS BEEN REC'D TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1