Safety and effectiveness of neurostimulation for pediatric use have not been established. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.Set the electrosurgery device to the lowest possible energy setting.Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.Confirm the neurostimulation system is functioning correctly after the procedure.ĭuring implant procedures, if electrosurgery devices must be used, take the following actions: Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.Įlectrosurgery. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.ĭiathermy is further prohibited because it may also damage the neurostimulation system components. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.ĭiathermy therapy. Physicians should also discuss any risks of MRI with patients. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The following warnings apply to this neurostimulation system. For more information about MR Conditional products, visit the Abbott product information page at neuromodulation.abbott. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and aĬomplete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at ). Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. 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 and The system is intended to be used with leads and associated extensions that are compatible with the system. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Read this section to gather important prescription and safety information. SPINAL COLUMN STIMULATION (SCS) PRESCRIPTION AND SAFETY INFORMATION
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