Class 2 Device Recall SenTiva DUO"

• Date Initiated by Firm: January 03, 2025
• Date Posted: January 30, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1068-2025
• Recall Event ID: 96063
• PMA Number: P970003
• Product Classification: Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
• Product: Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000-D Generator was commercially approved for distribution in the U.S. on May 13, 2020 via PMA P970003/S231. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).
• Code Information: Lot Code: Model No 1000-D UDI-DI: 05425025750528 Lot Numbers/Serial Numbers: 324841 324842 324843 324844 324845 324846 324847 324848 324849 324850 324851 332681 332682 332684 332685 332686 332687 332688 332689 332692 332693 332695 332696 332697 332699 332700 332701 332702 332704 332705 332706 332707 332708 332709 332710 332811 332812 332813 332814 332815 332820 332823 332826 332827 332829 332830 332831 332833 339950 340073 340106 340108 340110 340111 340112 340113 340114 340115 340116 340117 340118 340119 340120 340121 340122 340569 340570 340571 340572 340573 340574 340575 340576 340578 340579 340580 340581 340583 340584 340585 340586 340587 340588 340589
• Recalling Firm/ Manufacturer: LivaNova USA, Inc.; 100 Cyberonics Blvd; Houston TX 77058-2069
• For Additional Information Contact: LivaNova Customer Quality; +1-866-8828804
• Manufacturer Reason for Recall: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
• FDA Determined Cause: Device Design
• Action: On January 3, 2025, LivaNova issued a "Urgent Medical Device Removal" via Mail to affected consignees. LivaNova ask consignees to take the following actions: 1. Monitor the patient for changes in clinical symptoms or if the patient loses perception of stimulation (e.g., the typical cadence for patient visits range from every 3-12 months). 2. Perform system diagnostic testing at each patient office visit to monitor generator battery status. 3. Counsel patients to do the following: i. Notify you if there is a change in perceived clinical symptoms ii. Notify you if they no longer perceive any form of stimulation. iii. Patients with epilepsy who have Magnet Mode enabled should be reminded to use the patient magnet daily to check for the sensation of stimulation to confirm proper generator function, in alignment with recommendations in product labeling for all VNS generator models. Notification Acknowledgement Follow one of the options below to acknowledge receipt of this notification: Option 1 1. Using the QR Code or website address and access code on page 1 of this letter, access your customer page via our secure customer portal ( TRIEVR ) to provide the required information to LivaNova USA, Inc. via a secure, transmission-encrypted system. 2. Answer the question in the Response section indicating your receipt and acknowledgement of the notification. 3. Submit the response by selecting the Send Response button at the bottom of the page.
• Quantity in Commerce: 84 units
• Distribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR,PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT and the countries of AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN,IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Luxembourg, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands, Turkey, UAE, 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 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