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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy Demipulse Generator and VNS Therapy Demipulse Duo Generator

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  Class 2 Device Recall VNS Therapy Demipulse Generator and VNS Therapy Demipulse Duo Generator see related information
Date Initiated by Firm November 20, 2009
Date Posted January 14, 2010
Recall Status1 Terminated 3 on July 24, 2012
Recall Number Z-0642-2010
Recall Event ID 54020
Product Classification Autonomic Nerve Stimulator Implanted For Epilepsy - Product Code LYJ
Product 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.
Code Information Model 103: Manufactured from 1/25/2007 - present; Model 104: Manufactured from 1/25/2007 - present.
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact
800-332-1375 Ext. 223
Manufacturer Reason
for Recall		 Under certain conditions, product's battery life can be reduced.
FDA Determined
Cause 2		 Other
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 clinicaltechnicalservices@cyberonics.com.
Quantity in Commerce 8,667 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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