Recharge-Free SCS Systems

Proclaim™ Plus and Proclaim™ XR Spinal Cord Stimulation (SCS) Systems 

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scs products
scs products

SCS systems from Abbott deliver proprietary, low-energy BurstDR™ stimulation, providing up to 10 years of battery life at low-dose settings.* BurstDR™ stimulation has been evaluated in published clinical evidence for over 10 years* in more than 1,000 patients worldwide and has been proven to deliver consistent, superior and repeatable results.

This therapy is now indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral, bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain, diabetic peripheral neuropathy of the lower extremities, and nonsurgical back pain (for patients without prior surgery who are not candidates for back surgery).

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Recharge-free: Unlike other SCS systems that require frequent charging sessions, the Proclaim™ Plus and Proclaim™ XR SCS Systems offer up to 10 years of battery life at low-dose settings* without the hassles of charging. 

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NeuroSphere™ Virtual Clinic: You have access to NeuroSphere™ Virtual Clinic for secure remote neurostimulation programming and in-app video chat services that extend care beyond your clinic walls.

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MR Compatibility: This system also features full-body MR compatibility.§ 

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Extended Battery Life: This recharge-free platform harnesses the power of low-energy BurstDR™ stimulation to extend battery life and provide pain relief1 without the hassles of recharging. 

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Patient Controller App: Patients can manage their prescribed stimulation settings directly from an iOS software compatible app on their personal mobile devices. 

Proclaim™ Plus SCS System: flexibility for multi-site and evolving pain 

The Proclaim™ Plus SCS System with FlexBurst360™ therapy delivers a tailored approach to multi-site and evolving pain.

FlexBurst360™ therapy is the next generation of BurstDR™ therapy, which is clinically proven to improve people’s everyday activities2 and provide superior* relief from both pain and its associated suffering.3-4†

Patients experience complex pain4-5

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Multi-site pain
88% of chronic pain patients have two or more non-contiguous painful areas.5 FlexBurst360™ therapy produces broader myotomal coverage at lower amplitudes than single-area stimulation.6

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Less effective therapy due to evolving pain
Roughly 30% of SCS patients experience less effective therapy due to pain becoming more complex over time.7

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Upgradeable technology

The Proclaim™ Plus SCS System provides your patients the latest stimulation software without replacing the implant, allowing you to upgrade your technology wirelessly. 

Proclaim™ XR SCS System 

The Proclaim™  XR SCS System utilizes BurstDR™ stimulation to provide superior relief and a battery that lasts up to 10 years at low-dose settings* without the hassles of recharging.

This system offers the trusted benefits of BurstDR™ stimulation therapy and convenient patient features such as an easy-to-use mobile app, MR compatibility and upgradeable therapy. The system does not offer access to FlexBurst360™  therapy for multi-site and evolving pain. 

FDA-approved anatomical lead placement**

The Proclaim™ XR SCS System now offers two lead placement techniques:

  • Place the leads anatomically
  • Use paresthesia mapping

Paresthesia mapping is no longer required for BurstDR™ stimulation when the lead target is between T8 and T10, therefore reducing procedure time.10¶

Physicians can choose lead placement based on implant preference and procedure efficiency.

A proprietary waveform that is uniquely dosable

BurstDR™ stimulation is a unique and proprietary waveform that mimics natural firing patterns in the brain.11 A non-linear charge accumulation phase creates a powerful signal that modulates both the medial and lateral pathways.

This unique mechanism of action gives patients relief from both physical pain and the emotional suffering associated with the pain.12

Additionally, there is an observed carry-over effect6 meaning the therapy is effective even after stimulation is turned off.13

Extend care beyond your clinic walls with NeuroSphere™ Virtual Clinic

With the Proclaim™ Plus SCS system, your patients have access to remote programming with NeuroSphere™ Virtual Clinic – an in-app video chat service that allows your patients to remotely receive follow-up care without visiting the clinic. 

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Significantly reduced pain with dosing of BurstDR™ stimulation: BOLD study14

Abbott’s BoldXR™ dosing protocol identifies the lowest dose that ensures therapeutic effect. The BOLD study,14 which examined the efficacy of different dosed BurstDR™ stimulation programs in patients with chronic intractable pain, revealed that this type of dosed stimulation:

  • Delivered statistically significant reduction in pain,
  • Led to significantly improved quality of life, and
  • 76% pain reduction in trial responders.

With low-energy doses used in a large percentage of patients, battery longevity may be significantly increased with dosed BurstDR™ stimulation.

BurstDR™ stimulation significantly improves emotional pain responses: TRIUMPH study

Because BurstDR™ stimulation also treats the medial spinothalamic pathway that regulates the emotional aspects of pain, this stimulation has the potential to modify patients’ psychosocial functioning. The TRIUMPH study12 results revealed that 1 year after receiving a Proclaim™ XR SCS System with BurstDR™ stimulation, subjects showed significant and sustained improvements in physical, mental, and emotional functioning, as well as quality of life (QOL).

The greatest changes were observed for pain catastrophizing, depression, and quality of life.4 And with catastrophizing found to be the most accurate predictor of QOL,15 TRIUMPH revealed that catastrophizing returned to levels observed in a healthy non-chronic pain population.4  TRIUMPH revealed:

  • Catastrophizing returned to levels observed in a healthy non-chronic pain population,
  • Opioid use reduced significantly at both six and 12 months, and that
  • 89% of subjects recommended BurstDR™ stimulation at both six and 12 months.12

Consider BurstDR™ stimulation to resolve SCS loss of efficacy: Burst(able) Study 

When patients experience loss of efficacy (LOE) related to traditional SCS therapy, physicians shouldn’t presume a failure of neuromodulation overall; such cases could be a failure of that one particular type of stimulation.16 The BURST(able) study showed that introduction of BurstDR™ stimulation—after LOE from traditional SCS therapy—can be an effective option for treating LOE, as well as potentially reducing opioid consumption. The majority of patients reported their former complaints had been rectified after being switched to BurstDR™ stimulation: 72% in the non-surgical revision group and 89% in the surgical revision group.16

Ordering Information

ProductReorder Number
Proclaim™ XR 5 IPG3660
Proclaim™ XR 7 IPG3662
Proclaim™ Plus IPG 53670
Proclaim™ Plus IPG 73672

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NOTE:  BurstDR™ stimulation, patented technology exclusively from Abbott, is also referred to as Burst stimulation in clinical literature.

* Up to 10 years of battery longevity at the lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s/off. NOTE: In neurostimulation therapy, ‘dose’ refers to the delivery of a quantity of energy to tissue. Safety comparisons and specific dose-response curves for each dosage have not been clinically established. Refer to the IFU for additional information. Hassle-free means recharge-free.

† When compared to tonic stimulation.

§ Within approved parameters. Refer to the IFU for full details on MR Conditional scan parameters.

‖ Pain and suffering as measured by VAS. 

¶ Not powered for hypothesis testing.

** Only for SCS systems enabled with BurstDR™ stimulation. Only approved in the U.S.

 

  1. De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013;80(5):642-649.e1.

  2. De Ridder D, Vanneste S, Plazier M, van der Loo E, Menovsky T. Burst spinal cord stimulation: toward paresthesia-free pain suppression. Neurosurgery. 2010;66(5):986-990.

  3. Falowski SM. An observational case series of spinal cord stimulation waveforms visualized on intraoperative neuromonitoring. Neuromodulation. 2019;22:219-228.

  4. Falowski SM, Moore GA, Cornidez EG, et al. Improved psychosocial and functional outcomes and reduced opioid usage following burst spinal cord stimulation. Neuromodulation. 2021;24(3):581-590.

  5. Deer T, Slavin KV, Amirdelfan K, et al. Success using neuromodulation with BURST (SUNBURST) Study: results from a prospective, randomized controlled trial using a novel burst waveform. Neuromodulation. 2018;21(1):56-66.

  6. Courtney P, Espinet A, Mitchell B, et al. Improved pain relief with burst spinal cord stimulation for two weeks in patients using tonic stimulation: results from a small clinical study. Neuromodulation. 2015;18(5):361-366. doi:10.1111/ner.12294

  7. Schu S, Slotty PJ, Bara G, von Knop M, Edgar D, Vesper J. A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. Neuromodulation. 2014;17(5):443-450.

  8. Pop-Busui R, Boulton AJ, Feldman E.L., et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154. doi:10.2337/dc16-2042

  9. Abbott. Clinical Summaries: Spinal Cord Stimulation Systems. Clinician's Manual; 2023.

  10. Pope JE, Schu S, Sayed D, et al. Anatomic lead placement without paresthesia mapping provides effective and predictable therapy during the trial evaluation period: results from the prospective, multicenter, randomized, DELIVERY Study. Neuromodulation. 2020;23(1):109-117. doi:10.1111/ner.13019

  11. De Ridder D, Vanneste S, Plazier M, Vancamp. T. Mimicking the brain: evaluation of St. Jude Medical’s Prodigy chronic pain system with burst technology. Expert Rev Med Devices. 2015;12(2):143–150. doi:10.1586/17434440.2015.985652

  12. Hagedorn JM, Falowski SM, Blomme B, Capobianco RA, Yue JJ. Burst spinal cord stimulation can attenuate pain and its affective components in chronic pain patients with high psychological distress: results from the prospective, international TRIUMPH study. Spine J. 2022;22(3):379-388. doi:10.1016/j.spinee.2021.08.005

  13. Saber M, Schwabe D, Park HJ, et al. Tonic, burst, and burst-cycle spinal cord stimulation lead to differential brain activation patterns as detected by functional magnetic resonance imaging. Neuromodulation. 2022;25(1):53-63. doi:10.1111/ner.13460

  14. Deer TR, Patterson DG, Baksh J, et al. Novel intermittent dosing burst paradigm in spinal cord stimulation. Neuromodulation. 2021;24(3):566-573. doi:10.1111/ner.13143

  15. Sullivan MJL, Lynch ME, Clark AJ. Dimensions of catastrophic thinking associated with pain experience and disability in patients with neuropathic pain conditions. Pain. 2005;113(3):310-315.

  16. Hunter CW, Carlson J, Yang A, et al. BURST(able): A retrospective, multicenter study examining the impact of spinal cord stimulation with burst on pain and opioid consumption in the setting of salvage treatment and “upgrade.” Pain Physician. 2020;23(6):E643-E658. PMID:33185383

Important Safety Information

Spinal Column Stimulation (SCS) Systems

Intended Use

This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.

Indications For Use

Abbott Medical spinal cord stimulation (SCS) systems are 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, nonsurgical back pain (without prior surgery and not a candidate for back surgery), and diabetic peripheral neuropathy of the lower extremities.

Contraindications

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.

MRI Safety Information

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. 

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 medical.abbott/manuals). 

For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html

Warnings

The following warnings apply to this neurostimulation system.

Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

Magnetic resonance imaging (MRI). 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. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients. 

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. 

Diathermy therapy. 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. 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.

Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 

Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure. 

  • Use bipolar electrosurgery only.

  • Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.

  • Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.

  • Set the electrosurgery device to the lowest possible energy setting.

  • Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.

Implanted cardiac systems. 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. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. 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 the implantable cardiac system.

Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system.

Interference with other devices. Some of this system’s electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Avoid placing equipment components directly over other electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected.

Operation of machines, equipment, and vehicles. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. However, current data shows that most patients using BurstDR™ stimulation therapy do not experience paresthesia. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment.

Explosive and flammable gasses. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of these devices could cause them to ignite, causing severe burns, injury, or death.

Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to avoid damage. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing.

Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.

Use in patients with diabetes. Surgical complications and adverse effects may be more frequent and severe in patients with diabetes. 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).
  • Monitor the patient’s blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes.
  • Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes.

Stimulation modes. The BurstDR™ stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population.

Device components. 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.

Device modification. Equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.

Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (that is, jailbroken).

Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.

IPG disposal. Return all explanted IPGs to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.

Product materials. Neurostimulation systems have materials that come in contact or may come in contact with tissue. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted.

Precautions

The following precautions apply to this neurostimulation system.

General Precautions
  • Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.

  • Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.

  • Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.

  • Implantation of two systems. 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.

  • Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.
  • Implant healing. While charging the generator, patients may perceive an increase in temperature at the generator site. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation.
  • High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations occur, the device should be turned off immediately.

  • Electromagnetic interference (EMI). 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 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).
  • Consumer goods and electronic devices. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) away from the generator and avoid placing any smart device in a pocket near the generator. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support.
  • Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) six to eight weeks after implantation of a neurostimulation system. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation.
  • Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system.

  • Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient.

Sterilization and Storage
  • Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.

  • Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind.

Handling and Implementation
  • Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.
  • Recharge-by-date. A recharge‑by date is printed on the packaging. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation.
  • Handle the device with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.

  • Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.

  • Package or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to Abbott Medical for evaluation.

  • Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. 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.

  • System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.

Hospitals and Medical Environments
  • High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.

  • Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.

  • External defibrillators. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.

  • Therapeutic radiation. 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. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Home and Occupational Environments
  • Security, antitheft, and radiofrequency identification (RFID) devices. 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. 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.
    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. Patients should cautiously approach such devices and should request help to bypass them. 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.

  • Scuba diving or hyperbaric chambers. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician.

  • Wireless use restrictions. In some environments, the use of wireless functions (for example, Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 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. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: 

  • Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately

  • 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

  • Stimulation in unwanted places (such as radicular stimulation of the chest wall) 

  • Lead migration, causing changes in stimulation or reduced pain relief 

  • 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, or pain below the level of the implant 

  • Persistent pain at the electrode or IPG site 

  • Seroma (mass or swelling) at the IPG site

  • Allergic or rejection response to implant materials 

  • Implant migration or skin erosion around the implant 

  • Battery failure

  • Changes in blood glucose levels in response to any adverse effect 

    NOTE: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate preoperative glycemic control. For adverse effects observed in the use of diabetic peripheral neuropathy, refer to the clinical summaries manual for SCS systems.

Safety And Effectiveness Studies

For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system.  

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 

(2) The method of its application or use.

 

23-78280 MAT-2215216 v4.0 | Item approved for U.S. use only.

23-79008 MAT-2213751 v4.0 | Item approved for U.S. use only.