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U.S. Department of Health and Human Services

Class 2 Device Recall Cyberonics

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  Class 2 Device Recall Cyberonics see related information
Date Initiated by Firm May 06, 2011
Date Posted October 04, 2011
Recall Status1 Terminated 3 on December 04, 2012
Recall Number Z-0005-2012
Recall Event ID 59139
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product 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.
Code Information Serial #'s: 2181, 3427, 3902, 4082, 4083, 4116, 4129, 4132, 4158, 4177, 4185, 4204, 4235, 4304, 4351, 4495, 4591, 4610, 4621, 4716, 4728, 4737, 4823, 4834, 4855, 4904, 5105, 5165, 5220, 6039, 6046, 6121, 6124, 6234, 6343, 6513, 6552, 6625, 6674, 6680, 6682, 6700, 6715, 7662, 7738, 7875, 8008, 8163,8820, 8971, 9010, 9171, 9213, 9215, 9217, 9222, 9241, 9260, 9283, 9312, 9333, 9398, 9442, 9451, 9547, 9552, 12590, 12672, 18644, 21949, 22061, 22177, 22455, 22814, 23267, 23736, 25079, 25125, 25545, 25888, 26212, 26254, 26346, 26513, 26527, 26847, 26912, 26932, 27012, 27026, 27127, and 32232.
Recalling Firm/
Manufacturer		 Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact Bryan Olin
281-228-7323
Manufacturer 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.
FDA Determined
Cause 2		 Software design (manufacturing process)
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 clinicaltechnicalservices@cyberonics.com
Quantity in Commerce 92 units
Distribution 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.
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 and Original Applicant = LivaNova USA, Inc.
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