London medical device-maker LivaNova is recalling a system that treats adults and children over 4 years old with partial onset seizures that haven't responded to epilepsy medications.
The FDA classified the recall as Class I, the most serious type, meaning the use of the devices could cause serious injury or death.
The VNS Therapy SenTiva Generator System is also used to treat major depressive episodes in patients 18 years or older who haven't responded to antidepressants.
The device 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, a process called vagus nerve therapy.
LivaNova is recalling the devices after discovering a reset error that causes the system to stop delivering VNS therapy. If a replacement device is needed, there is an additional risk with surgery to replace the generator.
LivaNova has received 14 reports of unexpected reset errors, and four patients have required early revision surgery for failed devices. No deaths have been reported.
It also found that all of the reports of unexpected reset errors happened within the first 60 days of implanting the device in a patient.
Patients with the device should notify their healthcare provider immediately if they see a change in their symptoms, such as an increase in seizures or depressive symptoms.
LivaNova said it is working with the FDA to fix the error, and if patients discover they have an affected device, they should notify LIvaNova and work with their healthcare provider to find alternate treatment options.
Read the full news release here.