CE marking does not necessarily indicate regulatory approval status for all markets. Please refer to the instructions for use for a full listing of indications, contraindications, warnings and precautions.
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 are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. 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. Adverse Effects: Unpleasant or undesirable stimulation, surgical risks (e.g., paralysis), allergic response. Clinician’s Manual must be reviewed prior to use for detailed disclosure.Bluetooth is a trademark of Bluetooth SIG, Inc.
Last Updated: December 18, 2018
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