NEUROMODULATION
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ST. JUDE MEDICAL™ INVISIBLE TRIAL SYSTEM FOR SCS

          

          

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A TEMPORARY PAIN CONTROL SYSTEM THAT’S EASY AND INTUITIVE

Neurostimulation can be an effective way for your patients to manage their pain and live the life they want. But getting an implant is a big decision. Before your patients commit to surgery, the St. Jude Medical™ Invisible Trial System for SCS may be an opportunity for you to determine if spinal cord stimulation with BurstDR™ stimulation* is right for them.

OVERCOMING OBSTACLES TO CHRONIC PAIN RELIEF

The St. Jude Medical™ Invisible Trial System for spinal cord simulation (SCS) provides a way for you and your patients to evaluate SCS therapy for managing chronic pain. It’s a discreet, temporary system using a small external generator that’s practically invisible under clothing. There are no external cables, and your patients can adjust their therapy wirelessly using an Apple† iPod Touch† controller. The system is designed to remove some of the barriers between patients and SCS, helping patients focus on evaluating SCS therapy, rather than managing the system

91 Percent of Chronic Pain Patients Would proceed with SJM Invisible Trial System

DELIVERING BURSTDR™ STIMULATION

If you have patients who have not had success with SCS therapy in the past, BurstDR™ stimulation offers a new opportunity for pain relief. BurstDR™ stimulation is a unique form of neurostimulation proprietary to Abbott. It uses a novel waveform proven to deliver superior pain relief over conventional tonic stimulation.2-4 It works by emulating natural firing patterns in the brain and is believed to modulate both the sensory and emotional pathways1—providing patients potential relief from their physical pain, as well as the suffering** associated with the pain.2-4

For 89% of patients, BurstDR™ stimulation reduces or eliminates the paresthesia felt with traditional tonic stimulation.2-4 Consider using a temporary system like the St. Jude Medical™ Invisible Trial System to see if BurstDR™ stimulation can work for your patients

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A CONVENIENT TRIAL SYSTEM FOR YOU AND YOUR PATIENTS

APP-BASED PROGRAMMING

The St. Jude Medical™ Invisible Trial System for SCS helps reduce learning curves5 by providing patients with a more intuitive iPod touch† mobile digital device as a controller, while their doctor uses an iPad mini† to program and evaluate their therapy. The St. Jude Medical™ Invisible Trial System is the first and only app-based patient programming device using Apple† mobile digital devices.6

SMALLEST EPG

The system also features a discreet external pulse generator (EPG) designed to be virtually undetectable under clothes. The EPG is designed to closely mimic the experience of a permanent implant.

Man’s torso with iPhone and EPG
  1. Once placed, the leads connect directly to the EPG device.
  2. Working with your patient, you determine stimulation programs using the clinician programmer app on an iPad mini† mobile digital device.
  3. Your patient uses an app on an iPod touch† mobile digital device to self-adjust stimulation delivered by the EPG

BURSTDR(TM) STIMULATION: CLINICALLY SUPERIORITY, REAL-WORLD REPLICATION2,7-20

The Proclaim™ Elite Recharge-free SCS System is powered by BurstDR™ stimulation, a proprietary stimulation mode available only from Abbott. BurstDR™ stimulation has been proven to provide superior pain relief as compared to tonic stimulation.2-4

By emulating natural firing patterns in the brain, BurstDR™ stimulation is believed to effectively modulate both the sensory and emotional pathways in the brain—giving your patients relief from both their pain and the suffering** associated with the pain.1,2 The advantages of this revolutionary therapy are supported by a growing body of clinical evidence from around the world.

SUNBURST STUDY: DEMONSTRATED SUPERIORITY OF BURSTDR™ STIMULATION OVER TONIC STIMULATION2

The SUNBURST study was a prospective, randomized, controlled trial to assess BurstDR™ Stimulation vs traditional tonic for the treatment of chronic pain (n = 100). BurstDR™ Stimulation delivered significantly greater reduction in chronic pain compared to traditional tonic stimulation (p < 0.017).** .

BurstDR improvement in VAS

BURSTDR™ STIMULATION DELIVERS CONSISTENT, POSITIVE RESULTS2,7-20

BurstDR Stimulation has not only proven to have superiority over tonic stimulation in a large, randomized, controlled trial, but it has also shown consistent and replicable results across diverse clinical settings around the world over nearly a decade.

In 602 patients, over 8 years, and 3 continents, BurstDR™ Stimulation has been proven to provide consistent, repeatable, and superior‡ relief from pain and suffering.**,‡

BurstDR 23 percent decrease in VAS

Weighted average = an average that normalizes for study size. Based on the collection of final VAS/NRS scores from publications using BurstDR™ stimulation. Not all real world data came from randomized controlled multicenter clinical studies.

PATIENTS PREFER THE RELIEF AND CONTROL OF BURSTDR™ STIMULATION2,7,9,10,13,15,16,22

Patient preference for BurstDR™ stimulation is clear – and supported by a growing body of clinical evidence from around the world. Replicable clinical experience indicates that nearly 9 out of 10 patients prefer BurstDR™ stimulation for their chronic pain

87 percent of chronic pain patients prefer BurstDR

Based on weighted average from studies with preference data

TECH SPECS

Reorder Number

Dimensions (H x W x T, cm)

Weight (g)

Volume (cc)

Battery

RF Generator Type

3599

8.0 (with header) x 5.7 x 1.1

45.7 (with batteries)

44.6

CR2450 Coin Cell

Bluetooth® wireless technology 4.0

Accessories

 

 

 

 

 

Reorder Number

Description

 

 

 

 

3032

Header Kit

 

 

 

 

3013ANS

Multilead Trial Cable

 

 

 

 

1212ANS

Batteries

 

 

 

 

 

QUESTIONS ABOUT REIMBURSEMENT?

We’ve got the answers you’re looking for.

 

References:

*BurstDR™ neurostimulation, exclusively from St. Jude Medical, is also referred to as Burst stimulation in clinical literature.
†Apple and iPod Touch are trademarks of Apple, Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc.
**Pain and suffering as measured by VAS.
When compared to traditional tonic stimulation, supported by SUNBURST.

1.   Stirman, T., Hargett, J., Fontenot, H., & Peichel, D. (2015, June). Evaluating the invisible spinal cord stimulation trial system—Results from the INSTINCTS study. Presented at the meeting of the North American Neuromodulation Society, Las Vegas, NV. N = 75.
2.   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. 2017.
3.   St. Jude Medical. (2016). St. Jude Medical™ Proclaim™ Neurostimulation System Clinician’s Manual. Plano, TX.
4.   St. Jude Medical. (2016). St. Jude Medical™ Prodigy™ Neurostimulation System Programming and Reference Manual. Plano, TX.
5.   St. Jude Medical. (2015). NSR Report 60066593/A.
6.   Abbott. Data on File. Memo SJM-PROC-0815-0020(1).
7. 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.
8. Bara B, Schu S, Vesper J. First results of Burst high frequency stimulation in failed FBSS stimulation patients. One year follow up. Neuromodulation. 2013;16(5):e136.
9. De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World neurosurgery. 2013;80(5):642-649.e641.
10. 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.
11. Espinet A, Courtney P, Mitchell B, et al. Burst spinal cord stimulation provides superior overall pain relief compared to tonic stimulation. Pain practice: the official journal of World Institute of Pain. 2014;14(s1):114.
12. De Vos CC, Bom MJ, Vanneste S, Lenders MW, de Ridder D. Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. Neuromodulation. 2014;17(2):152-159.
13. 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.
14. De Ridder D, Lenders MW, De Vos CC, et al. A 2-center comparative study on tonic versus burst spinal cord stimulation: amount of responders and amount of pain suppression. Clinical Journal of Pain. 2015;31(5):433-437.
15. Tjepkema-Cloostermans MC, de Vos CC, Wolters R, Dijkstra-Scholten C, Lenders MW. Effect of Burst Stimulation Evaluated in Patients Familiar With Spinal Cord Stimulation. Neuromodulation. 2016;19(5):492-497.
16. Colini-Baldeschi G, De Carolis G, Papa A, et al. Burst stimulation for chronic low back and leg pain. 8th World Congress of the World Institute of Pain; 2016; New York, USA.
17. Kretzschmar M, Vesper J, Van Havenbergh T, et al. Improved pain and psychosocial function with Burst SCS: 1 year outcomes of a prospective study. Neuromodulation. 2017;20(7):e450.
18. Kinfe TM, Muhammad S, Link C, Roeske S, Chaudhry SR, Yearwood TL. Burst Spinal Cord Stimulation Increases Peripheral Antineuroinflammatory Interleukin 10 Levels in Failed Back Surgery Syndrome Patients With Predominant Back Pain. Neuromodulation: Technology at the Neural Interface. 2017;20(4).
19. Wahlstedt A, Leljevahl E, Venkatesan L, Agnesi F. Cervical burst spinal cord stimulation for upper limb chronic pain: A retrospective case series. Poster presented at 16th Annual Pain Medicine Meeting; 2017; Lake Buena Vista, FL.
20. Muhammad S, Roeske S, Chaudhry SR, Kinfe TM. Burst or High-Frequency (10 kHz) Spinal Cord Stimulation in Failed Back Surgery Syndrome Patients With Predominant Back Pain: One Year Comparative Data. Neuromodulation. 2017.
21. De Ridder, D., Vanneste, S., Plazier, M., & Vancamp, T. (2015). Mimicking the brain: Evaluation of St. Jude Medical’s Prodigy Chronic Pain System with Burst Technology. Expert Review of Medical Devices, 12(2), 143–150.
22. Deer, T, et. Al. Randomized, Controlled Trial Assessing Burst Stimulation for Chronic Pain: Two-year Outcomes from the SUNBURST Study.  Poster presented at North American Neuromodulation Society Meeting; 2018; Las Vegas, NV

IMPORTANT SAFETY INFORMATION

Spinal Cord Stimulation

Prescription and Safety Information

Read this section to gather important prescription and safety information.

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 

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 intractable low back and leg pain.

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 manuals.sjm.com). For more information about MR Conditional products, visit the Abbott product information page at neuromodulation.abbott.

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.

  • During implant procedures, if electrosurgery devices must be used, take the following actions:
  •  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.

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.

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.

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.

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.

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).

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.

Wireless use restrictions. In some environments, the use of wireless functions (e.g., 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.)

Mobile phones. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system.

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.

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.

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.

Device modification. The 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.

Hospital and Medical Environments

High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, 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.

Adverse Effects 

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

  •  Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.)
  • Stimulation in unwanted places (such as radicular stimulation of the chest wall)
  • Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
  • Persistent pain at the 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

Dorsal Root Ganglion (DRG) Therapy

Prescription and Safety Information

Read this section to gather important prescription and safety information.

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 

This neurostimulation system is indicated for the management of chronic, intractable pain.

Contraindications 

This system is contraindicated for patients who are

  • Unable to operate the system
  • Poor surgical risks
  • Pregnant
  • Under the age of 18

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 manuals.sjm.com). For more information about MR Conditional products, visit the Abbott product information page at neuromodulation.abbott.

Warnings

The following warnings apply to this neurostimulation system.

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

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

External defibrillators. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. After defibrillation, confirm the neurostimulation system is still working

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, 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.

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. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment.

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.

During implant procedures, if electrosurgery devices must be used, take the following actions:

  • 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

Emergency procedures. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion.

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.

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.

Restricted areas. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker.

Component manipulation by patients. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection.

Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Excessive lead migration may require reoperation to replace the leads.

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.

Operation of machines, equipment, and vehicles. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. 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.

Explosive and flammable gases. 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.

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. The 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 (i.e., 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 multiple leads. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.

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.

Postural changes. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. However, some patients may experience a decrease or increase in the perceived level of stimulation. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. If unpleasant sensations occur, the IPG should be turned off immediately.

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.

Package or component damage. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. 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. Return any suspect components to Abbott Medical for evaluation.

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.

Lead inspection. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target.

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.

Component handling. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function.

Using surgical instruments. Do not use surgical instruments to handle the lead. The force of the instruments may damage the lead or stylet.

Component manipulation. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space.

Stylet handling. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Use care when reinserting a stylet. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Remove the stylet from the lead only when satisfied with lead placement. If the stylet is removed from the lead, it may be difficult to reinsert it.

Sheath insertion precaution. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura.

Stabilizing the lead during insertion. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Failure to do so may cause harm to the patient such as damage to the dura.

Bending the sheath. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead.

Lead handling. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Failure to do so may result in difficulty delivering the lead.

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.

Component disposal. Return all explanted components to Abbott Medical for safe disposal.  

Hospital and Medical Environments

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

Home and Occupational Environments

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, 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).  

Wireless use restrictions. In some environments, the use of wireless functions (e.g., 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.)

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.

Mobile phones. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system.

Adverse Effects 

In addition to those risks commonly associated with surgery, the following risks are associated with 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 or breakage
  • Stimulation in unwanted places (such as 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
  •  Tissue damage or nerve damage
  •  Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant
  •  Pain or bleeding where the needle was inserted
  •  Persistent pain at the electrode or IPG site
  •  Escalating pain
  •  Seroma (mass or swelling) at the implant site
  •  Headache
  •  Allergic or rejection response to device or implant materials
  •  Implant migration or skin erosion around the implant
  •  Battery failure, leakage, or both
  •  Hardware malfunction that requires replacing the neurostimulator
  • Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain

 

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. This may occur once the lead is in place and is connected to the neurostimulator and activated. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Additionally, all patients will be awake and conversant during the procedure to minimize the impact.

SJM-NWEB-0718-0136(1)

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