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VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx… recallZ-0561-2020 · LivaNova USA Inc · initiated Aug 22, 2019

Class I Terminated All recalls posted in December 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from LivaNova USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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 [email protected]. 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

Recall details

Recall number
Z-0561-2020
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Aug 22, 2019
Posted by the FDA
Dec 20, 2019
Recalling firm
LivaNova USA Inc
Quantity
1687
Product code
LYJ
FDA submissions
P970003
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

Product description

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

23 devices cleared under P970003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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