Patients should cautiously approach such devices and should request help to bypass them. All of our lead anchor models can be used.

The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. This allows you and your doctor to determine if DRG therapy is effective for your pain before undergoing an implant. Failure to do so may cause harm to the patient such as damage to the dura. The system is intended to be used with leads and associated extensions that are compatible with the system. PROCLAIM™ DRG IPG. Do not resterilize or reimplant an explanted system for any reason. IPG disposal. 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. All Rights Reserved. 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. Scuba diving and hyperbaric chambers. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Clinician training. Follow proper infection control procedures. This novel option is the only stimulation therapy proven to effectively deliver precise, long-term relief for patients suffering from focal chronic pain in the lower body.*,1,2. You can also learn more about how DRG therapy works and receiving a system. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Do not use surgical instruments to handle the lead. **Precise pain in the foot, knee, hip or groin due to CRPS types I and II. Security, antitheft, and radiofrequency identification (RFID) devices. Operation of machines, equipment, and vehicles. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Lead handling. All Rights Reserved. Implantation of multiple leads. Pain. Wireless use restrictions. 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. Read this section to gather important prescription and safety information. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target.

Expiration date. Device modification. Device components. Keep the device dry.

The Proclaim DRG neurostimulator system is built on a platform that includes Invisible Therapy™, a system offering discreet and patient-friendly Bluetooth® wireless technology and Apple‡ mobile digital programming. Therapeutic radiation. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Diathermy therapy. 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 systemsettings that interfere with the function of the implantable cardiac system.

Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. If unpleasant sensations occur, the device should be turned off immediately. 2017; 158(4):669-681.

If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Diathermy is further prohibited because it may also damage the neurostimulation system components. Scuba diving and hyperbaric chambers. 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, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). If your patients are unsure about having a neurostimulator implanted, you may have the opportunity to offer them a noninvasive trial of DRG therapy. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at manuals.sjm.com). One of the benefits of DRG therapy is that you can be fitted with a temporary device that works like an implanted system but can be removed. This novel option is the only stimulation therapy proven to effectively deliver precise, long-term relief for patients suffering from focal chronic pain in the lower body. Follow proper infection control procedures. The data from the ACCURATE study suggests that DRG stimulation may offer a meaningful treatment aid for patients suffering from focal chronic pain conditions caused by CRPS who are currently underserved by traditional SCS.

Using surgical instruments. Access our MRI ready resources and learn about our scan parameters. Our smallest neurostimulation device is designed for discreet, rechargeable chronic pain therapy. Sheath insertion precaution. Infections related to system implantation might require that the device be explanted. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). 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. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app.

Component handling.

Keep them dry to avoid damage. Infection.

Exposure to body fluids or saline. ... Dorsal Root Ganglion (DRG) Therapy ... cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. All Rights Reserved. †69.5 percent of patients experienced more than 80 percent pain relief

The equipment is not serviceable by the customer. 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.

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