Product Safety Information: Prior to using these devices, please review the latest Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.
Indications for use: The Nalu Neurostimulation System is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Contraindications: Patients contraindicated for this therapy are those who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical risks, and/or are pregnant. Diathermy should not be operated within the vicinity of a patient implanted with a Nalu Neurostimulation System or when wearing a Therapy Disc. The energy from diathermy can be transferred through the stimulator and cause tissue damage, resulting in severe injury. Occupational exposure to high levels of non-ionizing radiation that may interfere with therapy – Patients who regularly work in environments with elevated levels of non-ionizing radiation should not be implanted with the device. The energy in high-level areas can be transferred through the device and cause tissue damage, resulting in severe injury. Examples of environments having high level non-ionizing radiation include the following: Radio or cell phone transmission stations, facilities using radiofrequency heat sealers or induction heaters, electric power infrastructure controlled environments (i.e. step down transformers or high voltage power lines). Patients who have implanted cardiac or other neurostimulation systems should not use the Nalu Neurostimulation System. Electrical pulses from the Nalu Neurostimulation System may interact with the sensing operation of an implanted cardiac or neurostimulation system, causing the system to respond inappropriately.
Warnings: Occupational exposure to high levels of non-ionizing radiation that may interfere with therapy, exposure to very strong EMI, electromagnetic equipment/environments, operators of heavy machinery or equipment, theft detectors and metal screening devices, temperature rise during stimulation, active implantable or body-worn medical devices, magnetic resonance imaging (MRI), computed tomography (CT) scanning, radiofrequency (RF) ablation, psychotherapeutic procedures, painful stimulation, strangulation, tampering, and tampering.
Precautions: Clinician training, sterilization, post-operative care, medical tests and procedures, TENS, bone growth stimulators, dental drills and ultrasonic probes, electrolysis, laser procedures, use as directed, use of another’s Therapy Disc, handling of Therapy Disc, keeping Trial Therapy Disc dry, Therapy Disc water resistance, cleaning of Therapy Disc, storage temperatures, random component failures, unexpected stimulation changes, airline policies, flammable or explosive environments, activities requiring excessive twisting or stretching, scuba diving and hyperbaric chambers, Remote Control interference, and adverse environments.
Adverse Effects: Risks related to the surgical procedure, risk related to stimulation (e.g. painful stimulation, loss of pain relief), risks related to the system. The User’s Guide must be reviewed for detailed disclosures.