Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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Excessive fibrotic reaction to device leading to pain and/or new pain symptoms.
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Unexpected stimulation effects including but not limited to: chest wall stimulation, muscle stimulation, tremor,
dyskinesia, superficial pain, cramping, light-headedness and metallic taste.
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Weakness.
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Numbness.
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Clumsiness.
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Tissue damage.
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Nerve damage.
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Paralysis.
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Swelling.
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Sensory loss.
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Discomfort during the treatment.
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Skin erosion around the Nalu Implantable system or at the site of the Nalu wearable devices.
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Battery failure
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Lead breakage requiring replacement of the Lead.
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Electromagnetic interference causing a change in System performance.
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Loss of therapeutic effect despite a functioning system.
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Hardware malfunction requiring replacement of the neurostimulator components.
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Pain from a non-injurious stimulus to the skin (allodynia).
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An exaggerated sense of pain (hyperesthesia).
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Change in stimulation that are possibly related to tissue changes around the electrodes, shifts in electrode
position, loose electrical connections, and lead or extension fractures which have been described by some
users as uncomfortable stimulation (a jolting or shocking sensation).
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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 days to many years after implant.
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Arrhythmia.
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Cardiac arrest.
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Intracranial hypotension.
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Fracture of the lead(s) or failure of other system components.
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Loss of therapy or unpleasant paraesthesia.
Adverse effects of stimulation are usually mild and go away when stimulation is turned off. Contact your clinician
immediately if you experience any problems. There may be changes in the level of pain control over time.
Notice: In the event of any serious incident that has occurred in relation to the Nalu Neurostimulation System, the
user should report the incident to Nalu Medical at +1.800.618.3402 or visit www.nalumed.com.
