St. Jude Medical Axium, User Manual

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 definite 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 

benefits 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) fluid 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