BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 1151029 · Received August 29, 2008

    Report

    Report Number
    1644487-2008-02067
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    April 1, 2007
    Report Date
    July 30, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROCEEDINGS OF THE 150TH MEETING OF THE SOCIETY OF FOREIGN NEUROLOGICAL SURGEONS', FOREIGN JOURNAL OF NEUROSURGERY, 21:2, 91 - 179. ABSTRACT ARTICLE F2-06: OUTCOME AND COMPLICATIONS OF VAGAL NERVE STIMULATOR IN CHILDREN WITH INTRACTABLE EPILEPSY. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    DURING REVIEW OF AN ARTICLE REGARDING OUTCOME AND COMPLICATIONS OF VNS IN CHILDREN WITH INTRACTABLE EPILEPSY, IT WAS REPORTED THAT A PATIENT HAD A LEAD FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE IN PROGRESS.

    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