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/or limbs, including unilateral or bilateral pain associated with the following: failed back
surgery syndrome and intractable low back and leg pain. 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). User’s Guide must
be reviewed for detailed disclosure.