Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications for Use: Spinal cord stimulation as an aid in the management of chronic, intractable pain of the trunk and limbs.
Contraindications: Patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.
Warnings/Precautions: Diathermy therapy, implanted cardiac systems, magnetic resonance imaging (MRI), explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, postural changes, pediatric use, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted.
Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). Clinicians manual must be reviewed for detailed disclosure.
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