BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2030761 · Received March 4, 2011

    Report

    Report Number
    1644487-2011-00425
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 9, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: ELLIOT, ROBERT, A. MORSI, A. SILVERBERG, C. CARLSON, E. GELLER, O. DEVINSKY, AND W. DOYLE. "CHANGES IN EFFICACY OF VAGUS NERVE STIMULATION (VNS) OVER TIME: REVIEW OF 65 CONSECUTIVE PTS WITH TREATMENT-RESISTANT EPILEPSY TREATED WITH VNS > 10 YEARS." DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A SCIENTIFIC ARTICLE THAT A LEAD FRACTURE OCCURRED AND WAS PRESENTED BY DELAYED NECK PAIN IN SYNCHRONY WITH THE STIMULATION DUTY CYCLE. THE PT UNDERWENT FULL REVISION SURGERY DUE TO THE LEAD FRACTURE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO 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