Neuropace RNS System - Page 11

Responsive Neurostimulator System 9
RNS
®
System User Manual
RNS
®
System should only be used by neurologists or neurosurgeons with adequate
experience in the management of intractable epilepsy and in the localization of
epileptic foci, including the use of scalp and intracranial electrodes.
Neurologists and neurosurgeons using the RNS
®
System must have completed the
NeuroPace
®
RNS
®
System training program. To qualify to manage patients with the
RNS
®
System, physicians must demonstrate specific expertise related to epilepsy,
video-EEG monitoring, interpretation of electrocorticograms (ECoGs), the
pharmacology of antiepileptic medications and selection of patients for epilepsy
surgery. Implantation of the RNS
®
System should be performed only by qualified
neurosurgeons at centers capable of providing comprehensive epilepsy care, i.e.
“Comprehensive Epilepsy Centers”. These centers should have the expertise to
provide diagnostic services that include video-EEG monitoring with scalp and
intracranial electrodes and neuroimaging, and are experts in the treatment of epilepsy
with antiepileptic medications, epilepsy surgery and devices.
WARNING: M
ANAGEMENT OF PATIENTS WITH THE RNS
®
SYSTEM BY PHYSICIANS AT CENTERS THAT DO
NOT
PROVIDE THE SERVICES PROVIDED AT COMPREHENSIVE EPILEPSY CENTERS
In some instances, post-implant programming may be conducted by neurologists
meeting the experience and certification requirements for neurologists at
Comprehensive Epilepsy Centers, but who are not practicing in such centers. This
situation might occur if the patient is not able to travel to a Comprehensive Epilepsy
Center for regular follow-up (e.g. because of distance from the Center or limited
access to transportation). These neurologists will be qualified by NeuroPace to provide
post-implant programming. After NeuroPace
®
RNS
®
System training is complete, the
qualified programming neurologist may receive external NeuroPace products
(programmer, remote monitor).
W
ARNINGS – SURGICAL
WARNING: C
OMPATIBILITY WITH SIMILAR IMPLANTABLE PRODUCTS
The NeuroPace
®
RNS
®
Neurostimulator, NeuroPace
®
Cortical Strip Lead, and
NeuroPace
®
Depth Lead are not compatible with non-NeuroPace leads and/or pulse
generators. Incompatible configurations may cause damage to the products and may
result in unsafe current densities delivered to the patient.
WARNING: C
ORTICAL STRIP LEAD EXPLANTATION
Explanting a chronically implanted cortical strip lead may cause tissue damage.
WARNING: I
NFECTION
Infection, including bacterial meningitis, may occur as a result of the RNS
®
System
implant procedures and/or the RNS
®
System materials. Standard surgical infection
prevention measures (antibiotics etc.) should be taken both pre- and post-implantation.
WARNING: I
NTRACRANIAL HEMORRHAGE
Intracranial hemorrhage may occur when implanting the RNS
®
System. Placing the
leads, ferrule, and/or neurostimulator in an area where excess pressure may occur to
the underlying blood vessels may cause intracranial hemorrhage. Patients with
underlying risk factors for intracranial hemorrhage, such as patients with previous