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U.S. Department of Health and Human Services

Class 1 Device Recall VNS Therapy SenTiva Generator, Model 1000

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  Class 1 Device Recall VNS Therapy SenTiva Generator, Model 1000 see related information
Date Initiated by Firm August 22, 2019
Date Posted December 20, 2019
Recall Status1 Open3, Classified
Recall Number Z-0561-2020
Recall Event ID 83873
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Code Information Serial Numbers Greater Than or Equal to 100000
Recalling Firm/
Manufacturer
LivaNova USA Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact
281-228-7200
Manufacturer Reason
for Recall
Certain Model 1000 generators (SN = 100,000) have experienced unexpected device resets, which resulted in disablement of therapy. Fourteen (14) complaints have been reported. Each of the device resets occurred within 60 days of enabling therapy. Once the device is disabled, therapy can be re-enabled, but the device will continue to be susceptible to resets. If a device experiences this issue and is disabled, patients may return to baseline seizure or depressive symptoms.
FDA Determined
Cause 2
Device Design
Action On 08/22/19, Urgent Medical Device Correction notices were sent to customers including Neurosurgery, Risk Management, Neurology, and doctors. Doctors were asked to do the following: 1) Monitor the patient frequently and continue to perform diagnostic testing at each visit per labeling. Information and recommendations regarding device checks, resets and monitoring of clinical symptoms can be accessed in the physician's manual. 2) If the initial interrogation of the generator is found to be disabled unexpectedly (0mA output current), contact Customer Quality at (866) 882-8804 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at cservices@livanova.com. 3) Ensure the patient does the following: a. (Epilepsy only) For patients that are able to do so and have Magnet Mode enabled, continue using their magnet regularly to verify that stimulation is felt as described by the labeling; and b. Notify their physician if there is a change in perceived clinical symptoms (e.g., increase in seizures/depressive symptoms, loss of perception of stimulation, etc.). 4) Please complete and return the attached Customer Response Form. Please return all potentially affected devices that remain in the hospital/facility inventory to the recalling firm. Further, a device update to resolve the issue in patient's devices is currently under development. The recalling firm will contact you as more information becomes available regarding this update. Please ensure that this notice is communicated to all personnel within your organization who need to be aware of it. Customers with additional questions are encouraged to call (866) 882-8804. On 10/08/19, Urgent Medical Device Correction notices were sent to doctors informing them that 1) Issue most likely to occur within first 60 days after enabling therapy, 2) Interrogate device at the end of titration visits (for new and replacement devices) to ensure settings remain programmed as intended, 3) Recalling firm is currently only distributing devices no
Quantity in Commerce 2909
Distribution U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR. OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT, SE, IT
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.
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