BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2020264 · Received March 11, 2011

    Report

    Report Number
    1644487-2011-00531
    Event Type
    Death
    Date Received
    March 11, 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. "VAGUS NERVE STIMULATION IN 436 CONSECUTIVE PATIENTS WITH TREATMENT-RESISTANT EPILEPSY: LONG-TERM OUTCOMES AND PREDICTORS OF RESPONSE."

    Description of Event or Problem · 1

    IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT A VNS PT EXPERIENCED A LEAD FRACTURE AND PRESENTED BY LOSS OF DEVICE EFFICACY. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL UNKNOWN NONE LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1