The NeuroCybernetic Prosthesis System is a vagus nerve stimulator, consisting of a generator which is implanted under the collar bone like a
pacemaker and connected by wire to the vagus nerve in the neck where it delivers electrical signals to the brain to control seizures. It includes an external programming system which is
used by the physician
to change stimulation settings. Patients can turn the stimulator on and off with a hand-held magnet by holding it over the stimulator.
Approved by the U.S. Food and Drug Administration (FDA) in 1997, the NeuroCybernetic Prosthesis System, made by Cyberonics, of Houston, is intended for use in conjunction with drugs or surgery in adults and adolescents with partial onset seizures,
the type of seizures that begin in one part of the brain and may remain localized or become generalized to the entire brain.
In March 2001, the FDA sent a warning letter to Cyberonics after receiving reports of 83 deaths and dozens of infections
linked to the NeuroCybernetic Prosthesis System. In the letter, the FDA accused the company of improperly reporting and recording the adverse events and of failing to investigate the cause of the deaths.
If you have suffered injuries due to the NeuroCybernetic Prosthesis System, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.Information Provided by the U.S. Food and Drug Administration
- Medical Devices & Implants