BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1810663 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00477
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Report Date
    October 8, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MURRAY, DIANA & YERBY, M. "EFFICACY OF VAGAL NERVE STIMULATION ON SELECTED PATIENTS WITH INTRACTABLE EPILEPSY".

    Description of Event or Problem · 1

    IT WAS REPORTED A VNS THERAPY PT DID NOT RECEIVE ANY BENEFIT FROM VNS THERAPY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1