Class 3 Device Recall VNS Therapy System Generator

• Date Initiated by Firm: February 07, 2008
• Date Posted: April 22, 2009
• Recall Status: Terminated on February 28, 2011
• Recall Number: Z-0995-2009
• Recall Event ID: 47442
• PMA Number: P970003
• Product Classification: implantable vagus nerve stimulator - Product Code LYJ
• Product: Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator.
• Code Information: All lots.
• 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: Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference, resulting in the loss of stimulation.
• FDA Determined Cause: Software design
• Action: Cyberonics notified consignees of recall via letter on 02/07/08. Consignees were notified of reset issue in which during a strong magnetic field, the software may report an error even though no error occurred. This error causes the generator to reset, which disables the generator (i.e., no stimulation delivered). Physicians should inform any potential and currently implanted patients of the possibility of this event. Patients should continue with their regularly scheduled visits as determined by their physician. If this event is suspected, physicians should interrogate the device as described in the Physicians Manual to confirm the generator has been reset and Cyberonics should be contacted for any additional instruction.
• Quantity in Commerce: 108 units.
• Distribution: Worldwide Distribution - USA, Belgium, Germany, Norway, Spain, Sweden, the Netherlands, and United Kingdom.
• 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.

• PMA Database: PMAs with Product Code = LYJ