BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1190871 · Received September 24, 2008

    Report

    Report Number
    1644487-2008-02324
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MCGLONE J, VALDIVIA I, PENNER M, WILLIAMS J, SADLER RM, CLARKE DB. QUALITY OF LIFE AND MEMORY AFTER VAGUS NERVE STIMULATOR IMPLANTATION FOR EPILEPSY. CAN J NEUROL SCI 2008;34:287-96.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE EVALUATING THE QUALITY OF LIFE FOR PATIENT'S IMPLANTED WITH THE VNS DEVICE FOR ONE YEAR THAT ONE PATIENT EXPERIENCED AN INCREASE IN SEIZURES. 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