Responsive Neurostimulator System 8
RNS
®
System User Manual
RNS
®
SYSTEM
INDICATIONS
The RNS
®
System is an adjunctive therapy in reducing the frequency of seizures in individuals 18
years of age or older with partial onset seizures who have undergone diagnostic testing that localized
no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and
currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and /
or secondarily generalized seizures). The RNS
®
System has demonstrated safety and effectiveness
in patients who average 3 or more disabling seizures per month over the three most recent months
(with no month with fewer than two seizures), and has not been evaluated in patients with less
frequent seizures.
C
ONTRAINDICATIONS
The RNS
®
System is contraindicated for:
• Patients at high risk for surgical complications such as active systemic infection, coagulation
disorders (such as the use of anti-thrombotic therapies) or platelet count below 50,000.
• Patients who have medical devices implanted that deliver electrical energy to the brain.
• Patients who are unable, or do not have the necessary assistance, to properly operate the
NeuroPace
®
Remote Monitor or magnet.
The following medical procedures are contraindicated for patients with an implanted RNS
®
System.
Energy from these procedures can be sent through the implanted brain stimulation system and cause
permanent brain damage which may cause severe injury, coma, or death. Brain damage can occur
from any of the listed procedures even if the RNS
®
Neurostimulator is turned off or if the leads are not
connected to the neurostimulator, and can occur even if the neurostimulator has been removed and
any leads (or any part of a lead) or the cranial prosthesis remain.
• MR imaging is contraindicated for patients with an implanted RNS
®
System. Do not perform an
MRI on a patient with any implanted RNS
®
Neurostimulator or lead (or any portion of a lead).
Even if the neurostimulator has been removed, you should not have an MRI if any part of a lead
or the cranial prosthesis is still implanted.
The RNS
®
System is MR Unsafe. Testing has not been performed to define conditions of use to
ensure safety of the RNS
®
System in an MR environment.
• Diathermy procedures are contraindicated in patients implanted with an RNS
®
Neurostimulator
and associated leads. (Diathermy is any treatment that uses high-frequency electromagnetic
radiation, electric currents, or ultrasonic waves to produce heat in body tissues.) Patients
absolutely CANNOT be treated with any type of shortwave, microwave, or therapeutic ultrasound
diathermy device whether or not it is used to produce heat. These treatments should not be
applied anywhere on the body.
• Electroconvulsive Therapy (ECT) is contraindicated for patients with an implanted RNS
®
System.
• Transcranial Magnetic Stimulation (TMS) is contraindicated for patients with an implanted RNS
®
System.
W
ARNINGS AND PRECAUTIONS
W
ARNINGS - CLINICAL USE
WARNING: P
HYSICIAN AND CENTER ACCESS TO THE RNS
®
SYSTEM
The RNS
®
System should only be implanted by neurosurgeons with adequate
experience in the implantation of subdural and stereotactic implantation of
intraparenchymal electrodes and in the surgical treatment of intractable epilepsy. The
To Next Page
Loading...