Patient selection. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Do not crush, puncture, or burn these devices because explosion or fire may result. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. The system is intended to be used with leads and associated extensions that are compatible with the system. Return any suspect components to Abbott Medical for evaluation. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) While charging the generator, patients may perceive an increase in temperature at the generator site. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Single-use, sterile device. Return of symptoms and rebound effect. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. 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. Do not crush, puncture, or burn the generator because explosion or fire may result. Infections may require that the device be explanted. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Avoid excessive stimulation. Inserting the anchor. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. Mobile phones. Removing a kinked sheath. Case damage. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). 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). System testing. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. 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. IPG placement. Deep brain stimulation complications include, but are not limited to, the following: Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture, Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture, Initial jolt or tingling during stimulation; jolting or shocking sensations, Lead fracture, migration, or dislodgement, Extension malfunction, fracture, or disconnect, Deep brain stimulation system failure or battery failure within the device, Deep brain stimulation system malfunction or dislodgement, Allergic or rejection response to implanted materials, Persistent pain, tightness, or redness at the incision sites or general pain, General erosion or local skin erosion over the IPG, Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck), Impaired wound healing (e.g., incision site drainage) or abscess formation, Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component, Stimulation-related complications or other complications, Worsening of motor impairment and Parkinsons disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia, Paresis, asthenia, hemiplegia, or hemiparesis, Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance, Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia, Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium, Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope), Eye disorder including eye apraxia or blepharospasm, (1) The symbol statement Rx only or only or the statement Caution: Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Damage to the system may not be immediately detectable. 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. Lead movement. 21 CR 801.109(b) The label of the device, other than surgical instruments, bears: (1) The symbol statement Rx only or only or the statement Caution: Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Schu S, Gulve A, ElDabe S, et al. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Unwanted changes in stimulation may include a jolting or shocking feeling. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Security, antitheft, and radiofrequency identification (RFID) devices. Operation of machines, equipment, and vehicles. Transcutaneous electrical nerve stimulation (TENS). Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. **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. IPGs contain batteries as well as other potentially hazardous materials. Long-term safety and effectiveness. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Overcommunicating with the IPG. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Use appropriate sterile technique when implanting leads and the IPG. Physicians should also discuss any risks of MRI with patients. The following warnings apply to this neurostimulation system. The device should be turned off and the doctor contacted if this occurs. IPG disposal. *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. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). 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. Removing each item in slow movements while holding the remaining components in place will assist this process. Set the electrosurgery device to the lowest possible energy setting. The implanted components of this neurostimulation system are intended for a single use only. Lead movement. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Inaccurate ECG results may lead to inappropriate treatment of the patient. After defibrillation, confirm the neurostimulation system is still working. High stimulation outputs. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. The safety and efficacy of the implantation of greater than four leads have not been evaluated. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. Avoid placing equipment components directly over other electronic devices.
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