Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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Scuba Diving or Hyperbaric Chambers –
Do not dive below 13 meters (45 feet) of water or enter hyperbaric
chambers above 1.48 atmospheres absolute (ATA) with the Nalu Implantable Pulse Generator. These conditions
can damage the device. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with the
clinician. Do not dive or enter hyperbaric chambers with the Therapy Disc.
Remote Control Interference–
If interference is suspected during use of the remote control, confirm that the
Bluetooth data transmission is operating properly. If the Nalu Remote Control application is not connecting to the
Therapy Disc:
a. Terminate the current stimulation program and shut down the Nalu Remote Control application.
b. Check for sources of Bluetooth interference in the surrounding area.
c. Remove or turn off the source of interference.
d. Re-establish the Bluetooth link with the Therapy Disc through pairing.
Reopen the Nalu Remote Control application and resume the therapy.
Adverse Environments –
Any user with a Nalu Neurostimulation System should seek medical guidance before
entering environments which could adversely affect the operation of the Nalu Neurostimulation System, including
areas protected by a warning against entry by users.
ADVERSE EVENT SUMMARY
Below is a list of side effects that may occur during surgery and/or during standard spinal cord
stimulation:
•
Undesirable changes in stimulation sensation and/or location with or without user movement.
•
Persistent post-surgical pain at hardware implantation sites.
•
Seroma or hematoma at surgery sites.
•
Spinal cord injury and or compression with subsequent neurological deficits - permanent or temporary.
•
Stroke.
•
Lead migration, causing the electrodes to move from the intended location.
•
Implantable Pulse Generator migration, which may or may not require surgical intervention.
•
Fracture of the lead(s) or failure of other system components, which may result in the loss of stimulation or
untoward stimulation induced dysesthesias.
•
Allergic or rejection reaction to the anesthesia, implanted components, or external components.
•
Reaction to the selected antibiotics or to the Nalu device including: rash, diarrhea, abdominal pain,
nausea/vomiting, dizziness, headaches, hypersensitivity (allergic) reactions
•
Undesirable skin problems such as infection, irritation, blistering, tearing or allergic reactions that may occur
during the use of any wearable component of the Nalu Neurostimulation System.
•
Skin irritation, including redness, itchiness, and bumpiness
•
Infection at implant site that may or may not require hospitalization and require treatment with antibiotic therapy
or surgical intervention
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Cerebral spinal fluid (CSF) leak inclusive of those requiring active medical intervention.
•
Inadequate pain relief or increase in pain following system implantation
•
Wound complications that may require medical intervention inclusive of surgical management.
•
Thromboembolic events requiring medical intervention; inclusive of deep vein thrombosis and pulmonary
embolism.
•
Death and/or catastrophic neurological complications.
•
Anesthetic complications - e.g. nausea, urinary retention.
•
Headache.
•
Bleeding.
