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References

Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018.

Deer TR, Patterson DG, Baksh J, et al. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation. Published online March 23, 2020. doi:10.1111/ner.13143. PMID: 32202044

Diwan, Sudhir, and Timothy R. Deer. Advanced Procedures for Pain Management. Springer International Publishing:, 2018. https://www.springer.com/gp/book/9783319688398

Rx Only

Brief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with needles and electrodes that are compatible with the system.

Indications for Use: The NT2000iX™ generator is intended for lesioning neural tissue. The NT2000iX™ generator is intended to be used for pain management. The NT2000iX™ generator is to be used only with separately cleared/approved lesion/temperature probes (NeuroTherm™ radiofrequency probes and SPINECATH™ and ACUTHERM™ catheters). The NT2000iX™ generator is indicated for use in the peripheral nervous system.

Warnings/Precautions: Hazardous electrical output, Electric shock hazard, Explosion Hazard, Fire Hazard, Pooling Hazard, Ignition Hazard, Fuse Replacement, Risk of RF burns to patient, Interference with active implants, Interference with other equipment, Probes. User’s Guide must be reviewed for detailed disclosure. User’s Guide must be reviewed for detailed disclosure.

DRG

Indications for Use:

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

International: Management of chronic intractable pain.

Contraindications:

US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation.

International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.

Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal flui