Surgical Procedures
41
RNS
®
System User Manual
1. Make a scalp incision at the desired neurostimulator implant location.
2. Trace the craniectomy template on the skull at the implant location.
3. Using a standard perforator, perform a craniectomy around the outside edge of the template
tracing.
4. Elevate the perforated portion of the skull to expose the dura.
WARNING: I
NTRACRANIAL
H
EMORRHAGE
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 head trauma or anticoagulant use, should be
taken into specific consideration.
RNS
®
Neurostimulator Implantation
Note: The neurostimulator may be implanted and secured in the craniectomy before or after the
tunneling of the lead(s).
1. Remove bone debris from the areas inside and surrounding the craniectomy.
2. Place the ferrule in the craniectomy. The one pre-bent ferrule tab can be used as a depth
guide for placement of the ferrule.
Note: To properly recess the ferrule into the skull, additional bone removal may be required
to accommodate the ferrule clamp.
3. Bend the three straight ferrule tabs to the appropriate depth using a needle driver or other
surgical instrument.
4. Place the neurostimulator in the ferrule to assess the fit and position. The neurostimulator
lead exit point should make a smooth transition to the top of the skull when the
neurostimulator is resting in the ferrule.
Note: The neurostimulator is packaged with a temporary white cover over the lead
contacts. Leave this cover in place until you are ready to attach the leads to protect
the contacts during handling.
5. Remove the neurostimulator from the ferrule.
6. Secure the four ferrule tabs to the skull using bone screws (not provided).
7. Partially seat the ferrule clamp in the ferrule using the torque driver to tighten the ferrule
clamp screw. Do not fully tighten the ferrule clamp (it should still be able to rotate freely).
