Advanced Neuromodulation Systems Inc. dba. St. Jude Medical Neuromodulation Division 001 Manual De Usuario
2
Genesis Programmer User’s Guide
INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS,
PRECAUTIONS AND ADVERSE EFFECTS
PRECAUTIONS AND ADVERSE EFFECTS
I
NDICATIONS
F
OR
U
SE
The Genesis (IPG) Neurostimulation System is indicated as an aid in the management of chronic
intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with any
of the following: failed back surgery syndrome, and intractable low back and leg pain.
intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with any
of the following: failed back surgery syndrome, and intractable low back and leg pain.
C
ONTRAINDICATIONS
The system is contraindicated for patients with demand type cardiac pacemakers.
If you are unable to operate the system or fail to receive effective pain relief during trial stimulation
you cannot be implanted with a SCS.
you cannot be implanted with a SCS.
W
ARNINGS
This section lists the potential hazards associated with spinal cord stimulation that you must
be aware of to avoid serious outcomes that may cause injury or death.
be aware of to avoid serious outcomes that may cause injury or death.
You should not use Spinal Cord Stimulation (SCS) if you are a poor surgical risk, have multiple
illnesses or active general infections.
illnesses or active general infections.
Diathermy Therapy – You cannot have any short-wave diathermy, microwave diathermy or
therapeutic ultrasound diathermy (all now referred to as diathermy) on your body if you have any
part of a spinal cord stimulator implanted. Energy from diathermy can be transferred through the
implanted system and can cause tissue damage at the location of the implanted electrodes, resulting
in severe injury or death.
therapeutic ultrasound diathermy (all now referred to as diathermy) on your body if you have any
part of a spinal cord stimulator implanted. Energy from diathermy can be transferred through the
implanted system and can cause tissue damage at the location of the implanted electrodes, resulting
in severe injury or death.
Diathermy is further prohibited because it may also damage the neurostimulation system
components resulting in loss of therapy, requiring additional surgery for system implantation and
replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation
system is turned "On” or “Off." You are advised to inform their health care professional that you
cannot be exposed to diathermy treatment.
components resulting in loss of therapy, requiring additional surgery for system implantation and
replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation
system is turned "On” or “Off." You are advised to inform their health care professional that you
cannot be exposed to diathermy treatment.
Operation of Machines, Equipment, and Vehicles — Do not drive, operate heavy machinery or
power tools with the stimulator turned on. Postural changes or abrupt movements could cause over-
stimulation (jolting sensation) that might cause you to lose control of your vehicle or equipment.
power tools with the stimulator turned on. Postural changes or abrupt movements could cause over-
stimulation (jolting sensation) that might cause you to lose control of your vehicle or equipment.
Magnetic Resonance Imaging (MRI) — You should NOT be subjected to an MRI. The
electromagnetic field generated by an MRI may dislodge implanted components, damage the device
electronics, and induce voltage through the lead that could cause a jolting or shocking sensation.
electromagnetic field generated by an MRI may dislodge implanted components, damage the device
electronics, and induce voltage through the lead that could cause a jolting or shocking sensation.
Theft Detectors and Metal Screening Devices — Certain types of antitheft devices such as those
used at entrances/exits of department stores, libraries, and other public establishments, and/or
airport security screening devices may affect stimulation. It is possible that patients who are
used at entrances/exits of department stores, libraries, and other public establishments, and/or
airport security screening devices may affect stimulation. It is possible that patients who are
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