BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2020357 · Received March 11, 2011

    Report

    Report Number
    1644487-2011-00501
    Event Type
    Injury
    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
    Adverse Event
    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 PATIENT EXPERIENCED COMPLICATIONS INCLUDING INFECTION, REQUIRING DEVICE REMOVAL. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK NONE LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention