| Class 1 Device Recall VNS Therapy SenTiva Generator, Model 1000 | |
Date Initiated by Firm | August 22, 2019 |
Date Posted | December 20, 2019 |
Recall Status1 |
Terminated 3 on March 28, 2024 |
Recall Number | Z-0561-2020 |
Recall Event ID |
83873 |
PMA Number | P970003 |
Product Classification |
Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
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Product | VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy |
Code Information |
Implanted devices with Serial Numbers Greater Than or Equal to 100000 that did not undergo the internal error screen. |
Recalling Firm/ Manufacturer |
LivaNova USA Inc 100 Cyberonics Blvd Houston TX 77058-2069
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For Additional Information Contact | 281-228-7200 |
Manufacturer Reason for Recall | Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation. |
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 | 1687 |
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 |
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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.
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PMA Database | PMAs with Product Code = LYJ
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