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VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc.… recallZ-0005-2012 · Cyberonics, Inc · initiated May 6, 2011

Terminated All recalls posted in October 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cyberonics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design (manufacturing process)

What the company is doing

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]

Recall details

Recall number
Z-0005-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 6, 2011
Posted by the FDA
Oct 4, 2011
Recalling firm
Cyberonics, Inc
Quantity
92 units
Product code
LYJ
FDA submissions
P970003
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.

Product description

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 (models, lots, serial numbers)

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.

Other devices under the same FDA submission

23 devices cleared under P970003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 59139).

Sources and updates

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