6
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 first 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 flow.
◦
RF Ablation – Uses radio frequency energy to cause controlled tissue damage.
◦
Microwave Ablation – Uses high speed alternating electric field to cause
controlled tissue damage.
◦
Dental procedures, electrolysis, static field 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 efficacy of
implantation of leads implanted above the T10 vertebral level has not been
evaluated.
•
Number of Leads Implanted –
The safety and efficacy of the implantation of
greater than 4 leads has not been evaluated.
• Back Pain -
The safety and efficacy for the treatment of patients who have back
pain as the greatest region of pain has not been evaluated.
Summary of Contents for Axium
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