VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)

Prospective, observational, un-blinded, multi-site study designed to collect data on
patients implanted with a Model 106 VNS Therapy System from baseline through an EMU stay of
up to 5 days, and 6-month follow-up. After the 6-month follow-up, patients will continue
follow-up for safety for approximately two years or until final regulatory approval of the
product.

Inclusion Criteria:

- Patients with a clinical diagnosis of medically refractory epilepsy with partial
onset seizures suitable for implantation with the VNS Therapy System.

- Patients willing to undergo an EMU evaluation for a period of at least three days
with activation of the AMM feature during that time.

- Patients must be at least 12 years old.

- Patients must be in good general health and ambulatory.

- Patient or guardian must be willing and able to complete informed consent/assent.

Exclusion Criteria:

- Patients have had a bilateral or left cervical vagotomy.

- Patients currently using, or are expected to use, short-wave diathermy, microwave
diathermy, or therapeutic ultrasound diathermy.

- A VNS Therapy System implant would (in the investigator's judgment) pose an
unacceptable surgical or medical risk for the patient.

- Patients expected to require full body magnetic resonance imaging (MRI).

- Patients have a history of implantation of the VNS Therapy.

- Patients with an IQ known or estimated to be < 70, history of depression requiring
hospitalization, or suicidality as defined by DSM IV-TR that in the investigator's
judgment would pose an unacceptable risk for the patient or prevent the patient's
successful completion of the study.

- Patients with a history of status epilepticus within 1 year of study enrollment.

- Patients with known clinically meaningful cardiovascular arrhythmias as well as
patients with clinically meaningful cardiovascular arrhythmias determined by a
24-hour Holter recording obtained during the baseline period.

- Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the
past 2 years.

- Patients with a history of psychogenic non-epileptic seizures.

- Women who are pregnant. Women of childbearing age must take a pregnancy test and
agree to use an approved method of contraception during the study.

- Patients currently enrolled in another investigational study.