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Additional Accessories
• Medical Alert Card:
Identifies 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 reflex 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.
Summary of Contents for Axium
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