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Responsive Neurostimulator System
®
RNS
S
YSTEM
I
NDICATIONS
®
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
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
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
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
•
MRI on a patient with any implanted RNS
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
Diathermy procedures are contraindicated in patients implanted with an RNS
•
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
•
Transcranial Magnetic Stimulation (TMS) is contraindicated for patients with an implanted RNS
•
System.
W
P
ARNINGS AND
RECAUTIONS
W
- C
U
ARNINGS
LINICAL
SE
WARNING:
P
HYSICIAN AND
The RNS
experience in the implantation of subdural and stereotactic implantation of
intraparenchymal electrodes and in the surgical treatment of intractable epilepsy. The
®
RNS
System User Manual
®
®
Neurostimulator or lead (or any portion of a lead).
®
System in an MR environment.
C
A
ENTER
CCESS TO THE
®
System should only be implanted by neurosurgeons with adequate
System has demonstrated safety and effectiveness
®
Neurostimulator is turned off or if the leads are not
®
System. Do not perform an
®
RNS
S
YSTEM
8
®
System.
®
Neurostimulator
®
System.
®
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