BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 1123809 · Received August 15, 2008

    Report

    Report Number
    1644487-2008-01922
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    January 1, 2004
    Report Date
    August 12, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "COMPLETE HEART BLOCK WITH VENTRICULAR ASYSTOLE DURING LEFT VAGUS NERVE STIMULATION FOR EPILEPSY." EPILEPSY & BEHAVIOR 5 (2004) 768-771. CONCLUSIONS: DEVICE FAILURE IS SUSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE THAT DURING INITIAL VNS PLACEMENT, A PRELIMINARY LEAD TEST SHOWED HIGHT LEAD IMPEDANCE. CORRECTIVE MEASURES WERE TAKEN, INCLUDING REPOSITIONING OF THE ELECTRODES, AND A STANDARD LEAD TEST WAS PERFORMED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR