BEUDAMED
    FDA Recall Terminated

    VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change stimulation settings The Demipulse Generator is an implantable multiprogrammable, device that delivers electrical signals to the vagus nerve. Electrical signals are delivered from the Demipulse Generator to the vagus nerve by the lead. The lead and the Pulse Generator make up the implantable portion of the VNS Therapy System. The external programming system includes the Programming Wand, the programming software, and a compatible computer. The programming software is used with the Programming Wand to allow a physician to read and change the Demipulse Generator settings transcutaneously. Indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures.

    Recall: Z-0642-2010 · Initiated November 20, 2009

    Recall

    Recall Number
    Z-0642-2010
    Event Number
    54020
    Firm
    Cyberonics, Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 20, 2009
    Posted
    January 14, 2010
    Terminated
    July 24, 2012
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change stimulation settings The Demipulse Generator is an implantable multiprogrammable, device that delivers electrical signals to the vagus nerve. Electrical signals are delivered from the Demipulse Generator to the vagus nerve by the lead. The lead and the Pulse Generator make up the implantable portion of the VNS Therapy System. The external programming system includes the Programming Wand, the programming software, and a compatible computer. The programming software is used with the Programming Wand to allow a physician to read and change the Demipulse Generator settings transcutaneously. Indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures.

    Reason

    Under certain conditions, product's battery life can be reduced.

    Action

    Firm sent "An Important Safety Notice" letter to all physicians explaining events, risks presented and recommended actions. Letter was mailed November 20, 2009. Physicians should complete and return the effectiveness card as soon as possible to acknowledge that you have read and understood the Safety Alert Letter. If further information is needed, customers in the US can contact Clinical Technical Support at 866-882-8804 or via email at [email protected].

    Distribution

    Worldwide Distribution -- USA, Argentina, Austria, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Iceland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Panama, Portugal, Republic of Germany, Saudi Arabia, Sweden, Slovakia, Spain, Switzerland, Taiwan, UAE, United Kingdom, and Venezuela.

    Quantity

    8,667 units