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Lead movement.
Patients should avoid bending, twisting, stretching, or lifting objects over 2 kg (5 lb) for six
to eight weeks postimplantation. Extension of the upper torso or neck may cause lead movement and alter
the stimulation field, resulting in overstimulation or ineffective stimulation.
Operation of machines, equipment, and vehicles.
turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous
machinery and equipment because sudden stimulation changes may distract them from properly operating
it. However, current data shows that most patients using BurstDR™ stimulation therapy do not experience
paresthesia. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur
and distract them while operating motorized vehicles, machinery, or equipment.
Postural changes.
Changes in posture or abrupt movements can change the level of stimulation and
potentially cause unpleasant sensations. Patients should turn stimulation off or lower the amplitude before
stretching, lifting their arms over their head, or exercising. If unpleasant sensations occur, turn off
stimulation.
Pediatric use.
Safety and effectiveness of neurostimulation for pediatric use have not been established.
Pregnancy and nursing.
have not been established.
Use in patients with diabetes.
in patients with diabetes. The following additional considerations should be made for patients with
diabetes:
▪
▪
A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for
ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a
Hemoglobin A1C (HbA1c) ≥8% (64 mmol/mol).
Safety and effectiveness of neurostimulation for use during pregnancy and nursing
Surgical complications and adverse effects may be more frequent and severe
Patients using therapy that generates paresthesia should
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