Use caution when sedating the patient. After defibrillation, confirm the neurostimulation system is still working. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Output power below 80 W is recommended for all activations. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. ** Keep dry to avoid damage. Physicians should also discuss any risks of MRI with patients. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Infection. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Transcutaneous electrical nerve stimulation (TENS). Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Advancing components. Keep the device dry. IPGs contain batteries as well as other potentially hazardous materials. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Wireless use restrictions. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Diathermy is further prohibited because it may also damage the neurostimulation system components. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. This includes oxygen-enriched environments such as hyperbaric chambers. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Use extreme care when handling system components prior to implantation. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. Neurostimulation should not be used on patients who are poor surgical candidates. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Scuba diving or hyperbaric chambers. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. An expiration date (or use-before date) is printed on the packaging. Charge density can be reduced by lowering the stimulation amplitude or pulse width. For more information, see the clinician programmer manual. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. Patients should cautiously approach such devices and should request help to bypass them. Care and handling of components. Therapeutic magnets. System testing. INDICATIONS FOR USE Operation of machinery and equipment. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Product materials. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. Patients should cautiously approach such devices and should request help to bypass them. Do not use the application if the operating system is compromised (i.e., jailbroken). Before reinserting the sheath, verify there is no damage to the sheath. Detailed information on storage environment is provided in the appendix of this manual. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. ), Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure or breakage, Stimulation in unwanted places (such as stimulation of the chest wall), Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage, Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, Pain or bleeding where the needle was inserted, Seroma (mass or swelling) at the implant site, Allergic or rejection response to device or implant materials, Hardware malfunction that requires replacing the neurostimulator, Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain, Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.). This neurostimulation system is indicated 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Failure to do so can damage or cut the lead or sheath. Programmer and controller devices are not waterproof. Removing a kinked sheath. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Overcommunicating with the IPG. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. commercial electrical equipment (such as arc welders and induction furnaces). Security, antitheft, and radiofrequency identification (RFID) devices. Back pain. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). Generator disposal. Explosive and flammable gasses. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. January 4, 2022 By Sean Whooley. Learn more about the scan details for our MR Conditional products below. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. (2) The method of its application or use. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support.
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