VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is 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, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
FDA Recall Z-0005-2012 · Posted 2011-10-04
Recalling FirmCyberonics, Inc
Recall StatusTerminated
Product CodeLYJ
Date Initiated2011-05-06
Date Terminated2012-12-04
Product Quantity92 units
Reason for Recall
An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient's Model 103 Generator.
Firm Action
The firm, Cyberonics Inc., initiated containment actions on March 17, 2011 to prevent additional affected devices from being shipped. The firm initiated contact with implanting facilities in the United States on May 6, 2011 and international facilities and distributors on May 10, 2011 to remove product from the field that has not yet been implanted. Additionally, a "Field Safety Alert" letter was sent to all affected medical professionals. The letter identifies the affected product, the issue, and the action(s) to be taken by the physicians. Consignees are instructed to complete and return an attached Effectiveness Check Form.
If assistance is needed physicians may contact Clinical Technical Support at 866-882-8804 or via email at [email protected]
Root Cause
Software design (manufacturing process)
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, OH, AR, MA, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OR, PA, TN, TX, UT, WA, WI and WV. Products were also distributed to WASHINGTON DC and Puerto Rico and the countries of: Austria, Belgium, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.