The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Recalled Product(s): VNS Therapy SenTiva Generator System
- Model Number: 1000
- Distribution Dates: April 19, 2019 to Current
- Devices Recalled in the U.S.: 2909
- Date Initiated by Firm: August 22, 2019
Device Use
The VNS Therapy SenTiva Generator System is used for Vagus Nerve Stimulation (VNS) therapy to reduce the frequency of seizures in adults and children over 4 years of age with partial onset seizures who have not responded to epilepsy medications. The VNS Therapy SenTiva Generator is also used for the treatment of major depressive episodes in patients 18 years of age or older who have not responded to antidepressant treatments.
The system detects and responds to heart rate increases that may be associated with seizures or depressive episodes by sending mild pulses to the brain through the vagus nerve. The system consists of an implantable VNS Therapy generator, a lead and electrodes around the vagus nerve, and an external programming system used by health care providers to change stimulation settings.
Reason for Recall
LivaNova is recalling the VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to stop delivering VNS therapy. If device replacement is needed, there is a risk associated with additional surgery to replace the generator.
LivaNova has received 14 reports of unexpected reset errors. 4 patients have required early revision surgery for failed devices. No deaths related to this issue have been reported.
On July 31, 2019, LivaNova implemented additional mitigations and at this time, no reset errors have been observed since implementation of these mitigations. These additional mitigations are currently under review by the FDA.
Who May be Affected
- Patients receiving VNS Therapy with the VNS Therapy SenTiva Generator System
- Health care providers who administer VNS Therapy to patients using the VNS Therapy SenTiva Generator System
- Hospital Risk Management departments with VNS Therapy SenTiva Generator Systems in their inventory
What to Do
On August 23, 2019 and August 26, 2019, LivaNova notified United States hospitals and healthcare providers of patients with an implanted VNS Therapy SenTiva Generator System about the recall through an Urgent Medical Device Recall Notification letter. On October 8, 2019, LivaNova sent healthcare providers a follow-up notification with actions patients and health care providers should take if they have the recalled device.
Actions Patients Should Take
- Notify a health care provider immediately if there is a change in symptoms such as increase in seizures or depressive symptoms, or perceived loss of stimulation. Caregivers of children implanted with an affected device, should have the health care provider verify that the device is functioning properly.
- Make sure you and your health care provider continue to:
- With Magnet Mode enabled, continue using the magnet regularly to verify that stimulation is felt as described by the labeling (For Epilepsy symptoms).
- At the beginning of each office visit, the health care provider will examine the device and perform diagnostic testing per labeling to verify the device is programmed to the intended settings, such as programming at last visit, and per scheduled programming protocol.
- At the end of each office visit the health care provider will examine the device per labeling and verify that the device is programmed to the intended settings.
- Complete and give the completed Customer Response Form attached to the notification to your health care provider. The health care provider will fax the Customer Response Form to (281) 853-1248 or e-mail the form to M1000FieldAction@livanova.com.
LivaNova is working with the FDA to mitigate this reset error. If your device has experienced a reset, please notify LivaNova and work with your health care provider to identify alternate therapy options, if appropriate. LivaNova will provide updates if new information becomes available.
Health care providers and patients can identify whether implanted devices were distributed prior to a screening procedure intended to detect devices susceptible to unintended device disablement on the LivaNova website.
Actions Health Care Providers Should Take
- All device disablements based on either physician or patient reporting have occurred within the first 60 days after therapy is enabled:
- During titration visits for initial and replacement implants, verify settings during office visit to ensure device is not affected by the issue.
- Patients with scheduled programming protocols enabled on their device may need to be seen more frequently during the first 60 days of titration.
- For patients whose therapy has been enabled for greater than 60 days, continue to follow LivaNova’s general recommendations in labeling to monitor the patient regularly.
- During titration visits for initial and replacement implants, verify settings during office visit to ensure device is not affected by the issue.
- At the beginning of each office visit, examine the device and perform diagnostic testing per labeling. Verify that patient is programmed to the intended settings such as programming at last visit, and per scheduled programming protocol.
- At the end of each office visit, just prior to the patient leaving the office, examine the device per labeling. Verify that the device is programmed to the intended settings.
- Information and recommendations regarding device checks, resets and monitoring of clinical symptoms can be accessed in the VNS Therapy Physician’s Manual, found in the Manuals Section of the LivaNova VNS Therapy website.
- If on examination the generator is found to be disabled unexpectedly (output current = 0mA), contact Customer Quality at (866) 882-8804 (Monday to Friday, 8 AM to 5 PM Central Standard Time) or the local sales representative to report the event and for troubleshooting assistance.
- Provide patients with information on alternate therapy.
- Ensure patients continue to do the following:
- With Magnet Mode enabled, continue using their magnet regularly to verify that stimulation is felt as described by the labeling (For Epilepsy symptoms).
- Notify their health care provider if there is a is a change in symptoms such as increase in seizures or depressive symptoms, or perceived loss of stimulation.
- Complete and return the attached Customer Response Form by fax to (281) 853-1248 or by e-mail to M1000FieldAction@livanova.com.
LivaNova is working with the FDA to mitigate this reset error. If your patient’s device has experienced a reset, please notify LivaNova and work with your patient to identify alternate therapy options, if appropriate. LivaNova will provide updates if new information becomes available.
Health care providers and patients can identify whether implanted devices were distributed prior to a screening procedure intended to detect devices susceptible to unintended device disablement on the LivaNova website.
Contact Information
Customers who have questions or concerns regarding this recall may contact Customer Quality at (866) 882-8804 (Monday to Friday, 8 AM to 5 PM Central Standard Time) or e-mail at cservices@livanova.com.
Additional Resources
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX to 1-800-FDA-0178.
