LivaNova USA Inc: VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy

Recall number

Z-0561-2020

Recalling firm

LivaNova USA Inc

Product

VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy

Status

Terminated

Initiated

2019-08-22

Posted

2019-12-20

Terminated

2024-03-28

Reason

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.

Root cause

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

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

Lot, serial or model codes

Implanted devices with Serial Numbers Greater Than or Equal to 100000 that did not undergo the internal error screen.

510(k) numbers

not on file

PMA numbers

["P970003"]

Product code

LYJ

Firm FEI

1000117004

Firm city

Houston

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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