So far, there have been at least six recalls of model 106 generators used to power Cyberonics vagus nerve stimulator (VNS) therapy systems. The VNS therapy systems are implanted devices used to treat seizures and epilepsy.
The U.S. Food and Drug Administration (FDA) has received more than 10,000 reports of injuries and death in people who have had Cyberonics VSN systems implanted.
A defective model 6 generator can cause the VNS to deliver too much electronic nerve stimulation or fail to deliver, either of which can have dangerous consequences including worsened depression or dangerous seizures that the device was meant to prevent.
Vagus Nerve Stimulators
The FDA approved the Cyberonics VNS Therapy System in 1997 for the treatment of epilepsy and expanded the approval to include treatment of depression in 2005. They are used in patients who have not responded to treatment with medication.
The device includes a generator and lead wire. The generator is implanted under the skin of the chest and the wire is threaded up to the neck where it is coiled around the left vagus nerve where it delivers electrical stimulation.
Recalls of the AspireSR Model 106 generators began in 2015. There have been several different defects, some of which can cause the device to stop delivering stimulation, deliver less than needed or to deliver stimulation when it should not.
If you believe that you have been harmed by a defective vagus nerve stimulator, please talk to an experienced defective medical device attorney right away to learn more about your rights.