SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimula

FDA device recall Z-1073-2025 · posted 2025-01-31 · Open, Classified

Recall details

Recalling firm

LivaNova USA, Inc.

Reason for recall

Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

Action taken

On 12/12/2024, correction notices were mailed to customers asking them to do the following: 1. Monitor patient frequently and perform an on-demand System Diagnostic test at each visit per labeling (typical patient visit cadence is every 3-12 months). See VNS Therapy Physician's Manual, found in the Manuals Section https://www.livanova.com/epilepsy-vnstherapy/en-us/hcp/product-manuals or https://www.livanova.com/depression/en-us/healthcare-provider-resources. 2. Counsel prospective and current patients to ensure that they are aware of and understand the risks. You may elect to provide the patient letter. 3. Contact Customer Quality at 1-866-882-8804 or e-mail at cservices@livanova.com if communication with the generator using the Programming System indicates that: i. Diagnostic tests cannot be performed (Error Code 254 - Test Interrupted error message) ii. System Diagnostic test displays a LOW lead impedance result. 4. Encourage patients to: i. Notify you if there is a change in perceived clinical symptoms (e.g. increase in seizures or depressive symptoms, etc.). ii. Notify you if they no longer perceive any form of stimulation. 5. Ensure that this notice is communicated to all personnel within your organization who need to be aware. 6. Complete and return the response form via email to M1000FieldAction@livanova.com Firm is updating the VNS Therapy Instructions for Use (IFU) to reflect the patient management recommendations relevant to this issue. For questions contact the firm's Customer Quality at 1-866-882-8804 or e-mail cservices@livanova.com On 6/16/2025, updated recall notices were delivered in person notifying customers that devices with a design change were available so affected generators remaining in inventory should be replaced. New devices with the design change have serial numbers greater than 500,000. There are no new actions for devices that have already been implanted.

Root cause

Device Design

Status

Open, Classified

Product code

LYJ

Quantity affected

48

Distribution

US: 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. OUS: AE, AR, AT, BE, BG, BR, CA, CL,

Date initiated

2024-12-12

Date posted

2025-01-31

Location

Houston, TX