St. Jude Medical Axium User manual

Caution: Federal (USA) law restricts the use of this device by or
on the order of a physician.
Axium™
Neurostimulator System
Patient Programmer
User Manual
Model MN10600-02

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its
subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and services marks of St. Jude
Medical, LLC and its related companies.
Pat. http://patents.sjm.com
© 2017 St. Jude Medical, LLC. All Rights Reserved.
Spinal Modulation is a wholly-owned subsidiary of St. Jude Medical, LLC.

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Table of Contents
EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE LABELING1
INTRODUCTION......................................................................................... 3
Description............................................................................................... 3
Trial Neurostimulator (TNS) ..................................................................... 3
Implantable Neurostimulator (INS)........................................................... 3
Implant Leads / Trial Leads / Lead Extension.......................................... 3
Connector Cable ..................................................................................... 3
Additional Accessories............................................................................. 4
Indications for Use ................................................................................... 4
Contraindications ..................................................................................... 4
Warnings and Precautions....................................................................... 4
Warnings.................................................................................................. 4
Warnings Regarding the Trial Neurostimulator ........................................ 7
Warnings - For Use in Home or Work Environments............................... 7
Precautions – For Your Programmer and Your Stimulator....................... 9
Precautions – For Your Therapy ............................................................ 10
Adverse Events...................................................................................... 11
RF Operating Frequencies..................................................................... 13
PROGRAMMER OVERVIEW.................................................................... 13
Programmer Features............................................................................ 14
Charging the Battery.............................................................................. 14
Programmer Power Up ......................................................................... 15
MAIN MENU.............................................................................................. 15
STIMULATOR BINDING............................................................................ 17
Magnet................................................................................................... 17

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CONNECTING WITH YOUR STIMULATOR............................................. 17
Pain Control Screen............................................................................... 18
ID Heading............................................................................................. 18
Select Group ......................................................................................... 19
Back to Main Menu ............................................................................... 19
Programmer Status Bar ......................................................................... 20
ADJUSTING YOUR STIMULATOR SETTINGS........................................ 20
Turn OFF All Stimulation........................................................................ 20
Pain Control Tab .................................................................................... 21
Turn Stimulation On or Off for a Body Region ....................................... 21
Adjust Stimulation to a Body Region...................................................... 21
DEVICE, PHYSICIAN AND CLINIC INFORMATION................................. 22
My Info Tab ............................................................................................ 22
Device Tab and Physician Tab ............................................................... 22
Stimulator Identication Information....................................................... 22
Physician Information............................................................................. 23
Clinic Tab ............................................................................................... 23
TO USE WITH YOUR TNS DEVICE ......................................................... 24
TO USE WITH YOUR INS DEVICE .......................................................... 24
CLEANING YOUR PROGRAMMER ......................................................... 24
DISPOSAL OF YOUR PROGRAMMER.................................................... 25
ENVIRONMENTAL CONDITIONS FOR STORAGE AND OPERATION... 25
GUIDANCE AND MANUFACTURER’S DECLARATIONS ........................ 25
APPENDIX I: TROUBLESHOOTING ........................................................ 29
TROUBLESHOOTING OTHER ISSUES................................................... 30

1
Explanation of Symbols on Product or Package Labeling
Model Number Read the Manual
Serial Number
i
Consult the Manual
Accessories Programmer
Manufacturing Date Manufacturer
Quantity Keep Dry
NON
STERILE
Contents of Package are Non-Sterile
Protected against Electric Shock
I P
20
Not waterproof. Applies to the Programmer when it is not in its carrying case.
I P
22
Limited waterproof. Applies to the TNS. Applies to the Programmer in its carrying
case.
Turns the Programmer ON and OFF. Turns stimulation OFF on the TNS.
-10°C
50°C
Store between -10°C and 50°C (14°F and 122°F)
Store between 0 and 93% humidity
The device is a radio transmitter
Magnet. Shows the location of the Programmer magnet.
Do not use if package is damaged.
Caution: Federal (USA) law restricts the use of this device by or on the order of
a physician.
MR Unsafe
Electrical Safety Certication
Follow instructions for use on this website.

2
Glossary
Lead – Surgical wire: takes electrical signals from the neurostimulator to the
stimulation area
Stimulation – Small electrical pulses: produces a tingling sensation and replaces pain
signals
Stimulator – Device that makes electrical pulses that will stimulate the nerves in your
spine: can refer to either the Trial Neurostimulator or Implantable Neurostimulator
Trial Neurostimulator (TNS)– External Stimulator that clips onto your belt: attaches
to the connector cable, which is connected to the leads that are implanted in the area
near your spine
Implantable Neurostimulator (INS) – Stimulator implanted in your back or abdomen:
attaches to leads implanted in the area near your spine
Connector Cable – Cable that connects the leads to your Trial Neurostimulator
Programmer – Portable, hand-held device: allows you to adjust your stimulation
settings
Clinical Programmer – Portable, hand-held device: allows the physician to program
your Stimulator.
Computer Tomography (CT) Imaging – Computerized X-ray imaging: produces
electronic images of tissues and organs
Diathermy – High energy heat: used to cut or cauterize during surgery or a type of
therapy
Electromagnetic Interference (EMI) – Electrical signals that interfere with the device
function
Magnetic Resonance Imaging (MRI) – Medical imaging: produces electronic images
of tissues and organs
Paresthesia – Tingling sensation felt during therapy delivery: produced by dorsal root
ganglion stimulation
Precaution – Situation that could cause uncomfortable stimulation and possible
damage to the Stimulator or Programmer
Program – Instructions or changes to stimulation settings that are put into the
Programmer and transmitted to the Stimulator
Stimulation Level – Amount of stimulation: can be increased or decreased within a
range set up by your doctor
Warning – Potentially serious hazard that could cause injury or death

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Introduction
Your Axium™Patient Programmer is used to program your Trial or Implantable
Stimulator. This User Manual gives detailed instructions on how to safely use your
Programmer and your Stimulator. See your doctor if you have any questions.
Description
The Axium Patient Programmer is a
portable, hand-held device. It is used to
communicate with your Stimulator. Your
Programmer contains information about
your Stimulator. You will use it to adjust your
stimulation settings or turn stimulation off. It
can run on its rechargeable battery. It can
also be plugged into a power outlet.
A Clinical Programmer is used by your
doctor to initially set up your Stimulator and
make adjustments later if needed. Only
your doctor and/or St. Jude Medical clinical
personnel use the Clinical Programmer.
Trial Neurostimulator (TNS)
The external TNS device connects to the Trial Lead(s) or
Lead Extensions and is worn for up to 30 days during the trial
period. The TNS device has a belt clip for your convenience.
Implantable Neurostimulator (INS)
The Axium™Implantable Neurostimulator (INS) is a non-rechargeable,
4-channel electronic device. It uses microelectronic circuitry, powered
by a hermetically sealed battery, to generate a pulsed waveform to
stimulate neural tissue.
Implant Leads / Trial Leads / Lead Extension
• Implant / Trial Leads: The Leads are designed for implant into
your body. Leads are comprised of surgical wire which takes
electrical signals from the neurostimulator to the stimulation
area.
• Lead Extension: The Lead Extension is intended to extend the length of the
lead and provide a connection between the lead and the Connector Cable or
the lead and the Implantable Neurostimulator. The Lead Extension is intended
for chronic implantation as a component of the Axium Neurostimulator System.
Connector Cable
• The Connector Cable connects the Leads or Lead Extension to the
external TNS.
LP0xxx Rev x
1
2
3
4

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Additional Accessories
• Medical Alert Card: Identies you as a user of the Neurostimulator System.
• Programmer Charger: To be used with the Patient Programmers to charge the
battery or allow use of the Programmers while plugged into standard electrical
outlets.
• Programmer Carrying Case: Protects the Programmer from water.
• Auxiliary Magnet: Allows you to turn off or communicate with the TNS or INS.
Indications for Use
The Axium Neurostimulator System is indicated for spinal column stimulation via
epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the
management of moderate to severe chronic intractable* pain of the lower limbs in
adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**
*Study subjects from the ACCURATE clinical study had failed to achieve adequate
pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug
classes and continued their pharmacologic therapy during the clinical study.
**Please note that in 1994, a consensus group of pain medicine experts gathered by
the International Association for the Study of Pain (IASP) reviewed diagnostic criteria
and agreed to rename reex sympathetic dystrophy (RSD) and causalgia, as complex
regional pain syndrome (CRPS) types I and II, respectively.
Contraindications
Patients contraindicated for the Axium Neurostimulator System are those who:
• Are unable to operate the system
• Are poor surgical risks
Patients who fail to receive effective pain relief during trial stimulation are contraindicated
to proceed to the INS procedure.
Warnings and Precautions
• Physicians should refer to the Physician Implant Manual for a complete list of
warnings and precautions for the Axium Neurostimulator System.
Warnings
• Do not use your Programmer or the Stimulator until your doctor has trained you.
• The safety and effectiveness of this therapy has not been established for
pregnancy, nursing, the unborn fetus, or delivery.
• The safety and effectiveness of the Axium Neurostimulator System has not
been established for pediatric use.
• Do not use your Programmer until your doctor has set up your Stimulator.
• Before having a CT scan, tell your doctor that you have an implanted device.
All stimulation for your device should be turned OFF before the procedure.
After the scan, your doctor should turn it back on and make sure the system is
working properly.
• Do not remove your leads or Connector Cable by yourself. This may cause
serious injury and could cause an infection.

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• Do not open or modify the Programmer or TNS. Keep them closed to protect
them. Modications to the device may cause improper operation.
• Do not transport the Programmer outside of its carrying case. Operate it only in
a moisture-free environment. The Programmer may malfunction if it becomes
wet.
• Power generators, arc welders and large magnetized speakers may cause
interference. Do not stand near these or similar devices.
• Be aware of where you place your Charger. Pets, children or you can become
entangled in the cord, which could cause a fall or strangulation.
• If contact with the Stimulator System causes a rash, report this to your doctor. If
your throat or tongue starts to swell, get emergency aid immediately.
• Please contact your doctor if you experience unusual pain or discomfort during
stimulation, or if the implant site is swollen, reddened, tender, or painful.
• Other Active Implantable Devices - The Axium Neurostimulator system may
interfere with other implanted stimulators, such as cardiac pacemakers and
debrillators which have sensing features, and may result in sensing problems
or inappropriate responses. The effect of other implanted devices, including
deep brain stimulators, peripheral nerve stimulators, implanted drug delivery
pumps, and cochlear implants on the Axium system are unknown.
• External Debrillators – Safety for use of external debrillator discharges
on those receiving neurostimulation has not been established. External
debrillation can cause induced currents in the lead-extension portion of the
neurostimulation system. After debrillation conrm the neurostimulation system
is still working.
• Magnetic Resonance Imaging – The Axium Neurostimulator system is MR
unsafe. Be advised to not undergo any elective magnetic resonance imaging
(MRI) with the entire system, or (in the case of removal of the implanted
generator) leads or lead fragments in place. Use of MRI in the vicinity of
the lead(s) may result in forceful dislodgment of the lead(s), or damage to
the Neurostimulator. If a voltage is induced through the lead, it may cause
uncomfortable (“jolting” or “shocking”) levels of stimulation or injury. MRI may
cause heating at the lead tip and unintended stimulation could result in tissue
damage.
• Computed Tomography (CT) – Please inform your doctor and medical
personnel conducting your CT scan that you have an implanted DRG system.
You must turn your device off temporarily while the scan is being conducted. It
is important that the person conducting your CT scan does the following:
◦Determines the device type;
◦If practical, tries to move external devices out of the scan range;
◦Minimizes x-ray exposure to the implanted or externally worn electronic
medical device by:
◦Using the lowest possible x-ray tube current consistent with obtaining the
required image quality; and
◦Making sure that the x-ray beam does not dwell over the device for more
than a few seconds.

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Important note: For CT procedures that require scanning over the medical device
continuously for more than a few seconds, as with CT perfusion or interventional
exams, attending staff should be ready to take emergency measures to treat
adverse reactions if they occur.
After CT scanning directly over the implanted or externally worn electronic
medical device:
◦You should turn your Axium Neurostimulator system device back on.
◦Check that the Axium Neurostimulator system is working properly.
◦Contact your doctor as soon as possible if you suspect the Axium system is not
functioning properly after a CT scan.
• Tell your regular doctors or healthcare providers that you have a Stimulator.
Do not have any elective medical procedures without rst discussing them with
your doctor. Some medical devices or therapies, such as those listed below,
may interfere with your Stimulator:
◦Electrocautery – Uses an electric probe to cauterize blood vessels and stop
bleeding during surgery.
◦Lithotripsy – Uses high-output shock waves to break up gallstones and kidney
stones.
◦Therapeutic Radiation – Uses ionizing radiation to destroy cancer cells.
◦High-output ultrasound – Uses high frequency sound waves to treat bone and
muscle injuries, or to stimulate muscle or improve blood ow.
◦RF Ablation – Uses radio frequency energy to cause controlled tissue damage.
◦ Microwave Ablation – Uses high speed alternating electric eld to cause
controlled tissue damage.
◦ Dental procedures, electrolysis, static eld therapeutic magnets and diagnostic
X-ray.
• Ultrasonic Scanning – Inform your doctor and medical personnel that ultrasonic
equipment may cause mechanical damage to the lead if used directly over the
site.
• Electrosurgery Devices – Inform your doctor and medical personnel that
electrosurgery devices should not be used in close proximity to implanted lead(s).
Contact between an active lead and the electrosurgical pencil can cause direct
stimulation of the contacted nerve and can cause severe injury. Electrosurgery
devices may also damage the lead and cause a loss of stimulation.
• Implantation at Vertebral Levels above T10 – The safety and efcacy of
implantation of leads implanted above the T10 vertebral level has not been
evaluated.
• Number of Leads Implanted – The safety and efcacy of the implantation of
greater than 4 leads has not been evaluated.
• Back Pain - The safety and efcacy for the treatment of patients who have back
pain as the greatest region of pain has not been evaluated.

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• Non-Emergency Procedures – Do not have non-emergency procedures while
undergoing trial stimulation.
• Emergency Procedures – Designate a representative (family member or close
friend) to notify any emergency medical personnel of your neurostimulator
implant, if emergency care is required. You will be provided with a Medical Alert
Card to carry with you to inform emergency medical personnel of your implant.
Be advised to use caution when undergoing any procedure that could include RF
or microwave ablation, debrillation or cardio version.
• Routine Medical Procedures – Do not undergo dental procedures, diathermy,
electrolysis, diagnostic ultrasound, static eld therapeutic magnets, diagnostic
X-ray, or high output ultrasonic lithotripsy. These procedures may provide
interference that can affect TNS or INS device operation or use or damage
components of the system that may cause patient harm. If you are given any
medical treatment in which an electrical current is passed through your body from
an external source, either the device should rst be deactivated, or care should
be taken to monitor the functioning of the neurostimulator during the initial stages
of treatment.
• Diathermy Therapy – Do not use short-wave diathermy, microwave diathermy,
or therapeutic ultrasound diathermy (all now referred to as diathermy) on
patients implanted with a neurostimulation system. Energy from diathermy can
be transferred through the implanted system and 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. This damage could result in loss of therapy, requiring additional
surgery for system removal and replacement. Injury or damage can occur during
diathermy treatment whether the neurostimulation system is turned on or off. All
patients are advised to inform their health care professionals that they should not
be exposed to diathermy treatment.
• Explosive or Flammable Gases – Do not use the patient programmer to
communicate with the INS or TNS in an environment where explosive or
ammable gas fumes or vapors are present. The operation of the programmer
could cause them to ignite, causing severe burns, injury, or death.
Warnings Regarding the Trial Neurostimulator
• Exposure to Fluids – Exposure of the external TNS or the Connector Cable
to water, body uids, saline, or cleaning agents can cause corrosion and affect
stimulation. Do not immerse the external TNS or Connector Cable in uids.
• Wear the TNS on the outside of your clothing or on a belt.
Warnings - For Use in Home or Work Environments
• Equipment Operation - Patients who feel an uncomfortable change in
paresthesia during motion should avoid driving a car or operating other
potentially dangerous machinery while stimulation is on. You could be distracted
from driving or device operation if sudden changes in stimulation occur.

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• Activities Related to Lead Movement - Limit your activities to low or moderate
levels during your trial stimulation period and the rst six weeks of implantation
of the INS. Failure to do so may result in migration of the leads causing loss of
stimulation therapy, muscle stimulation or painful stimulation thereby requiring
reoperation to reposition. You may turn off your device if stimulation becomes
uncomfortable.
◦Do not rub or press on the implant site. This may cause the leads to move or
your skin to erode. It may also cause the INS to move.
◦ Avoid excessive bending, twisting and stretching. Do not lift objects over ve
pounds. These activities may cause the leads to move. You may experience
higher or lower levels of stimulation.
• 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. If you have implanted non-adjacent multiple leads or
are sensitive to low stimulation thresholds you may experience a momentary
increase in perceived stimulation, which has been described as uncomfortable
or jolting. Use caution when approaching such a device and request assistance
to bypass the device. If you must proceed through the device, turn off the NS
and proceed with caution, being sure to move through the detector quickly.
• Restricted Areas – Seek medical guidance before entering environments
which could adversely affect the operation of the implanted device, including
areas protected by a warning notice preventing entry by patients tted with a
pacemaker.
• Scuba Diving and Hyperbaric Chambers – Avoid scuba diving and entering
hyperbaric chambers above 150 kPa. These activities may damage the Axium
system.
• Cell Phones - While interference with cell phones is not anticipated, cell phone
technology continues to change, and interaction with a neurostimulator system
is possible. Contact your physician if you have a concern about cell phone
interaction with your neurostimulator system.
• Electromagnetic Interference (EMI) – Electromagnetic interference is a
eld of energy generated by equipment found in the home, work, medical or
public environments that is strong enough to interfere with neurostimulator
function. Most electrical devices and magnets encountered in a normal day are
unlikely to affect the operation of a neurostimulator. Keep away from areas of
EMI and turn off the stimulator if they are in such an area. Sources of strong
electromagnetic interference can result in the following:
◦Operational changes –Operational changes to the neurostimulator, causing it
to turn on or off (particularly in neurostimulators enabled for magnet use), or to
reset to power-on- reset (POR) settings, resulting in loss of stimulation, return
of symptoms, and in the case of POR, requiring reprogramming by a clinician.
◦Unexpected changes in stimulation, causing a momentary increase in
stimulation or intermittent stimulation, which some patients have described as
a jolting or shocking sensation. Although the unexpected change in stimulation
may feel uncomfortable, it does not damage the device or injure you directly. In

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rare cases, as a result of the unexpected change in stimulation, patients have
fallen down and been injured.
Sources of potentially strong EMI include the following:
◦Microwave transmitters
◦Communication equipment such as microwave transmitters, linear power
ampliers, and high voltage power lines and power generators
◦Electric arc welding equipment
◦Large, magnetized stereo speakers
◦Radio frequency identication devices (RFID)
◦Antenna of citizens band (CB) or ham radio
◦Electric steel furnaces
◦Dental drills and ultrasonic probes
◦Electrolysis
Precautions – For Your Programmer and Your Stimulator
Follow these precautions to maintain proper function of your Programmer and
Stimulator.
• Do not drop or mishandle your Programmer or Stimulator. Physical damage to
the devices may keep them from working properly.
• Do not wash the Programmer or TNS device. Excess water may keep them
from working properly. Use a soft damp cloth to gently wipe the devices if
needed.
• Do not use abrasive or caustic cleaning products on your Programmer or TNS
device.
• Avoid contact with body uids for the TNS and Programmer. Contamination may
cause damage to the devices.
• Do not shower or bathe with the TNS device. You may take a sponge bath. You
must take care not to get the TNS device wet.
• Do not use any equipment or accessories that are not supplied with your
Programmer.
• Do not place your Programmer close to cards with magnetic strips. The
Programmer has a magnet that could demagnetize your cards. Keep the
Programmer away from computer hard drives and magnetic storage devices.
• Do not operate the Programmer or Stimulator outside the temperature range
of 5°C to 40°C (41°F to 104°F). Rapid temperature changes may affect device
operation.
• Do not store the Programmer outside the temperature range of -10°C to 50°C
(14°F to 122°F).
• Do not leave the Programmer in a car or other places where temperatures can
reach 50°C (122°F).
• An unlikely failure of your Stimulator System is possible due to random
component failure. If any part of your Stimulator System stops working or

10
changes how it works, turn stimulation OFF. Contact your doctor during normal
business hours.
• Return your Programmer and your TNS to your doctor at the end of the trial
period, or when no longer being used. Do not discard or burn the TNS or
Programmer. Fire may cause the internal batteries to explode.
• Do not attempt to dispose of the TNS or Programmer yourself.
• Do not replace the TNS or Programmer battery by yourself, even if it does not
seem to be working. Only St. Jude Medical personnel should replace the TNS
or Programmer batteries.
• Do not use any other company’s device to program your Stimulator. Use only
the Programmer provided by St. Jude Medical.
• Do not allow unauthorized use of your Programmer. This may cause unwanted
changes in the programming.
• Do not use the Charger if the power cord is damaged. This may cause injury or
damage your Stimulator.
• To remove power from the Charger when not in use, unplug it from the power
outlet.
• Avoid unnecessary programming of your device. Frequent usage will wear the
battery down faster.
• Do not open or shred the battery.
• Do not short-circuit the battery.
• Do not subject the battery to mechanical shock.
• In the event of a battery leak, do not allow the liquid to come in contact with the
skin or eyes. If contact has been made, wash the affected area with copious
amounts of water and seek medical advice.
• In case of a non-responding unit, St. Jude Medical personnel will observe the
plus (+) and minus (–) marks on the battery and equipment and ensure correct
use. They will also wipe the battery terminals with a clean dry cloth if they
become dirty.
• Keep the battery out of the reach of children.
• Seek medical advice immediately if a battery has been swallowed.
• Keep the Programmer clean and dry to prevent affecting the battery.
Precautions – For Your Therapy
Follow these precautions to maintain appropriate therapy:
• Follow the proper wound care techniques given to you by your doctor.
• When programming, temporary discomfort may be experienced due to quick
changes in stimulation output. Talk to your physician about enabling the Ramp
feature if this occurs.
• Appoint a family member or friend to tell emergency medical personnel that
you have a Stimulator, in case you need emergency care. You will be given a
Medical Alert Card to carry with you. This card will inform emergency medical
personnel that you have a Stimulator.
• High Stimulation Outputs – Stimulation at high outputs may cause unpleasant
sensations or motor disturbances or may render you incapable of controlling

11
the patient programmer. If unpleasant sensations occur, the device should be
turned off immediately.
• Stimulation Parameters – Stimulation parameters must be determined under
the supervision of your physician. Do not adjust stimulation parameters within
prescribed programs unless ordered to do so by your physician.
• Transcranial Magnetic Stimulation (TMS) and Electroconvulsive Therapy
(ECT) – Inform your doctor and medical personnel that safety has not been
established for TMS or ECT with your implanted neurostimulation system.
Induced electrical currents may cause heating, especially at the lead electrode
site, resulting in tissue damage.
• Transcutaneous Electrical Nerve Stimulation – Inform your doctor and
medical personnel that safety has not been established for transcutaneous
electrical nerve stimulation (TENS) electrodes and may cause TENS current to
pass over part of the neurostimulation system. If you feel that the TENS may be
interfering with the implanted neurostimulator, discontinue using the TENS until
you talk with your doctor.
• Therapeutic Radiation – Therapeutic radiation may damage the electronic
circuitry of an implanted neurostimulation system, although no testing has been
performed and no denite information on radiation effects is available. Sources
of therapeutic radiation include x-rays, cobalt machines, and linear accelerators.
If radiation therapy is required, the area over the implanted INS should be
shielded with lead.
• Long-Term Effectiveness of DRG Stimulation – The long-term effectiveness
of DRG stimulation has been documented. You may not realize long-term
benets from DRG stimulation. Stimulation effectiveness has been established
for one year.
Adverse Events
The implantation of a neurostimulation system involves risk. In addition to those
risks commonly associated with surgery, the following risks are also associated with
implantation and use of the Axium Neurostimulator System:
• Pain (where the needle has been inserted)
• Pain (caused by understimulation due to lead migration)
• Pain over the implantable neurostimulator site
• Escalating pain
• Bleeding (where the needle has been inserted)
• Headache
• Infection
• Localized collection of serous (clear) uid at injection site
• Discomfort during the treatment
• Allergic or rejection response to implant materials
• Constant pain at the lead site
• Stimulation of the chest wall
• Lead migration (movement) and/or local skin breakage
• Weakness

12
• Clumsiness
• Numbness
• Temporary muscle activation
• Cerebral Spinal Fluid (CSF) leakage
• Tissue damage
• Nerve damage
• Spinal cord compression
• Paralysis
• Hematoma
• Swelling
• Seroma
• Sensory loss
• Skin erosion around the INS or leads
• Battery failure and/or battery leakage
• Lead breakage requiring replacement of the lead
• Hardware malfunction requiring replacement of the neurostimulator
• Pain from a non-injurious stimulus to the skin (allodynia)
• An exaggerated sense of pain (hyperesthesia)
• Change in stimulation, possibly related to tissue changes around the electrodes,
shifts in electrode position, loose electrical connections, lead or extension
fractures, which has been described by some patients as uncomfortable
stimulation (jolting or shocking sensation).
• Formation of reactive tissue in the epidural space around the lead can result in
delayed spinal cord compression and paralysis, requiring surgical intervention.
Time to onset can range from weeks to many years after implant.
Additional risks, as a result of the placement and stimulation of the lead in the area of
the DRG, include pain due to setting the stimulation parameters too high. This may
occur once the lead is in place and is connected to the neurostimulator and activated.
The neurostimulator is controlled by a trained operator and the starting point for the
stimulation will be set to the lowest available settings. Additionally, all patients will be
awake and conversant during the procedure to minimize the impact.
If you have any concerns about your Stimulator, contact your doctor during normal
business hours.

13
RF Operating Frequencies
Nearby equipment emitting strong magnetic elds can interfere with RF
communication, even if the other equipment complies with CISPR emission
requirements. The operating characteristics are as follows:
MedRadio/MICS band: 402-405 MHz
The effective radiated power is below the limits as specied in
Europe: EN ETSI 301 839-2
USA FCC 47 CFR Part 95; 95.601-95.673 Subpart E, 95.1201-95.1219
FCC ID: Y8L-MN20600-02
This device may not interfere with stations operating in the 400.150–406.000 MHz
band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration
Satellite Services and must accept any interference received, including interference
that may cause undesired operation.
Programmer Overview
Your Axium Patient Programmer is a portable, hand-held device. It is powered by an
internal rechargeable battery. The Programmer can also be plugged into a power
outlet for use or for recharging. Your Programmer communicates with your Stimulator
to control your stimulation. Your doctor will explain how to use the Programmer to
adjust stimulation for your best pain relief.
Keep your Programmer near you at all times. This will allow stimulation adjustment,
if needed. Carry your Programmer in its carrying case. The case provides protection
from water.
Your Programmer System consists of:
• Programmer (and internal magnet) • Stylus
• Auxiliary Magnet • Charger
• Carrying Case • Patient Medical Alert Card
• Patient Quick Guide • Patient Programmer User Manual
(this document)
Stylus Programmer ChargerProgrammer

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Programmer Features
With your Axium Patient Programmer, you can:
• Turn stimulation ON or OFF for each body region
• Adjust the stimulation level for each body region
• Change the Group for stimulation - See “Select Group” under the “Pain Control
Screen” section
• Turn OFF all stimulation if needed
• View your Stimulator ID information
• View your ID number
• View your lead implant date
• View your doctor’s name, clinic name and contact information
Charging the Battery
The Programmer System comes with a Charger. The Programmer must be fully
charged before using it for the rst time. It takes approximately two to four hours
to fully charge the battery. The Programmer Status Bar at the bottom of the
screen shows the battery charge level.
The device is
charging when
the amber light
is on.
1. Plug the Charger into a power outlet.
2. Connect the Charger to your Programmer.
When the battery is charging, the battery icon on the screen shows “AC”. When
charging is complete, the amber light becomes green.
Your Programmer will operate when it is connected to a power outlet. It does not use
battery power when connected to an outlet. Connect your Programmer to the Charger
and plug it into an outlet regularly to keep it charged above 30%. Do not leave
Charger plugged into a power outlet overnight.
NOTE: Use only the Model MN23400-U Charger. It was included with your
Programmer. Use of any other charger could damage your Programmer.

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Press here
to turn on
Programmer
screen.
Reset pinhole is
on the back.
The battery can be expected to last at least 500 discharge cycles with normal use.
Once it fails to hold a charge, it should be replaced by St. Jude Medical personnel
only. Do not attempt to change the battery. Your Programmer and Charger can be
expected to last up to two years with normal use.
Programmer Power Up
Press the “ ” button to turn ON your Programmer screen. The Main Menu will
display.
NOTE: If your Programmer does not turn ON, charge the battery and try again.
Main Menu
The Programmer Main Menu displays two main functions:
• Connect: Allows you to connect to your Stimulator; also allows you to adjust
stimulation settings.
• Programmer Setup : Allows you to set your Programmer date and time, and
to view information about your Stimulator.
The Main Menu also shows your physician, and the clinic phone number.

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The Programmer status bar is at the bottom of the Main Menu. It displays your
Programmer–Stimulator connection status, the battery charge level and the time. See
the “Programmer Status Bar” section in this User Manual for more detail.
Programmer
status bar Programmer Setup
button
You can change the time and date and access the Programmer Info screen from the
Setup screen. You can also view your Stimulator serial number and your patient ID.
The Programmer Info screen displays your programmer serial number, programmer
software version, rmware version and manufacturing date.