Responsive Neurostimulator System 10
RNS
®
System User Manual
head trauma, anticoagulant use, or who experience head injury with seizures should
be taken into specific consideration.
WARNING: S
URGICAL PROCEDURE SIDE EFFECTS
Surgical procedure risks may include, but are not limited to, temporary pain at the
implant site, CSF leakage and although rare, epidural hemorrhage, seroma, subdural
or epidural hematoma and paralysis.
W
ARNINGS – RNS
®
SYSTEM AND THERAPY
WARNING: A
DVERSE TISSUE REACTION
Allergic reaction to the RNS
®
System materials and/or leads implanted is possible.
WARNING: C
HRONIC TISSUE STIMULATION
The effects of long-term brain stimulation are not completely known and may present
some risks to the patient.
WARNING: E
ROSION
Skin erosion may occur on and/or around the neurostimulator and/or lead implant site,
particularly in the case of protrusion of the implanted RNS
®
System products above
the surface of the skull.
WARNING: L
EAD MIGRATION
The implanted lead(s) may migrate from their desired implant location. Lead migration
can result in changes in detections and stimulation effectiveness, and may require
additional surgical procedures to modify the lead location.
WARNING: P
REGNANT WOMEN
The safety and effectiveness of the RNS
®
System has not been studied in pregnant
women.
WARNING: RNS
®
SYSTEM FAILURE
As with any electronic device, the RNS
®
System may malfunction (not work). Potential
causes include battery malfunctions, an electrical short, open circuits, lead fractures,
lead insulation failures, or damage as a result of head trauma. These malfunctions are
unpredictable, and may result in too little stimulation or no stimulation. A lead failure
may result in the lead needing to be removed or repositioned, which would require
surgery. A malfunctioning neurostimulator may need to be replaced, which would
require surgery. Although the neurostimulator is designed to turn off if overstimulation
or excess current occurs, there is a possibility that product failure could result in brain
tissue damage.
WARNING: P
ATIENT DATA COLLECTION
The patient must be willing to collect data daily from their neurostimulator and send the
data to the PDMS database at least once a week.
WARNING: C
ASE DAMAGE
If the neurostimulator case is ruptured or pierced due to outside forces, severe brain
tissue damage could result from exposure to the battery chemicals.
WARNING: E
LECTROMAGNETIC INTERFERENCE (EMI)
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