Sometimes the biggest innovations don't come as bright and shiny new inventions. Instead, they're found in incremental improvements.
That's the case with new research around 大秀视频's聽聽for chronic pain management. The system, which delivers electrical pulses to neutralize pain signals, isn't new. What is new is the revelation that the voltage can be tempered to save energy and battery life 鈥 without compromising pain relief.
A Life Less Interrupted
In a聽聽of BurstDR spinal cord stimulation, 100% of participants on a low-energy programming settings felt full pain relief on less than six hours of battery use per day, and 43% of participants achieved pain relief on less than 2 hours of battery use per day.
By understanding how the brain naturally manages pain, doctors created BurstDR stimulation to mimic natural patterns found in the brain.1聽It works by using mild electrical pulses to change pain signals as they travel from the spinal cord to the brain,2聽and BurstDR stimulation has been proven to provide effective pain relief in low doses.1
The result: With the , you can have hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings* without ever needing to charge the system.
Combined with the power of BurstDR鈩聽stimulation therapy, the Proclaim鈩聽XR SCS system is our latest advancement in neurostimulation therapy (also called SCS).
Not only does it offer you superior pain relief,** but unlike other SCS systems that require frequent charging sessions to maintain therapy, the Proclaim XR SCS system is recharge free. Meaning, you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings* without ever needing to charge the system.
Adam Hammond is one of the people reaping that benefit.
"I've only had my new stimulator for a few months and am already seeing the benefits of the new way the stimulation is delivered," said the 36-year-old husband and father of two, stricken with chronic pain for a decade following a skydiving accident. "Not only am I experiencing significant and continuous pain relief; I also don't have to charge my stimulator. For the first time since my accident, I can live a more seamless life both at work and at home with my family."
Lessons in Iteration
These findings mark a big improvement for Hammond and the thousands like him who depend on BurstDR stimulation as a treatment for聽chronic pain management. But it's also a lesson in how we think about innovation 鈥 maybe even a reason to rethink it.
In many fields, there's a tendency to conflate innovation with invention. What the BurstDR stimulation study shows is that innovation understandably can be about enhancement, the development of new ways to use things more efficiently, more effectively 鈥 or all of the above.
For people using BurstDR stimulation, it means taking control of their health and life.
References
1Deer T. Efficacy of Burst Spinal Cord Stimulation Microdosing in a De-Novo Patient. Poster presented at: NAPA Pain 2019.
2De 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 Review of Medical Devices. 2015:12(2):14-150.
* 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 traditional tonic stimulation
PRESCRIPTION AND SAFETY INFORMATION
DORSAL ROOT GANGLION (DRG) THERAPY
SPINAL CORD STIMULATION
Read this section to gather important prescription and safety information.
INTENDED USE聽
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聽
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 大秀视频 product information page at neuromodulation.abbott.
WARNINGS
The following warnings apply to this neurostimulation system.
Poor surgical risks.聽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).聽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 大秀视频 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.聽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.
贰濒别肠迟谤辞蝉耻谤驳别谤测.听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:
Implanted cardiac systems.聽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鈥檚 can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.
Pediatric use.聽Safety and effectiveness of neurostimulation for pediatric use have not been established.
Pregnancy and nursing.聽Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
Device components.聽The use of components not approved for use by 大秀视频 Medical with this system may result in damage to the system and increased risk to the patient.
Case damage.聽Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.
IPG disposal.聽Return all explanted IPGs to 大秀视频 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.
笔搁贰颁础鲍罢滨翱狈厂听
The following precautions apply to this neurostimulation system.
GENERAL PRECAUTIONS
CLINICIAN TRAINING.聽IMPLANTING PHYSICIANS SHOULD BE EXPERIENCED IN THE DIAGNOSIS AND TREATMENT OF CHRONIC PAIN SYNDROMES AND HAVE UNDERGONE SURGICAL AND DEVICE IMPLANTATION TRAINING.
Patient selection.聽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.
滨苍蹿别肠迟颈辞苍.听Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.
Electromagnetic interference (EMI).聽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.聽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.聽In some environments, the use of wireless functions (e.g., Bluetooth庐 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庐 is a registered trademark of Bluetooth SIG, Inc.)
Mobile phones.聽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.聽
STERILIZATION AND STORAGE聽
Single-use, sterile device.聽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.聽Store components and their packaging where they will not come in contact with liquids of any kind.聽
HANDLING AND IMPLEMENTATION聽
Expiration date.聽An expiration date (or 鈥渦se-before鈥 date) is printed on the packaging. Do not use the system if the use-before date has expired.
Care and handling of components.聽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.聽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 大秀视频 Medical for evaluation.
System testing.聽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.聽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 大秀视频 Medical for service.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy.聽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.聽The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.
External defibrillators.聽The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.
Therapeutic radiation.聽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聽
In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this IPG:
DORSAL ROOT GANGLION (DRG) THERAPY
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.
听颁翱狈罢搁础滨狈顿滨颁础罢滨翱狈厂
This system is contraindicated for patients who are
聽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聽manuals.sjm.com). For more information about MR Conditional products, visit the 大秀视频 product information page at neuromodulation.abbott.
听奥础搁狈滨狈骋厂
The following warnings apply to this neurostimulation system.
Pregnancy and nursing.聽Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
Pediatric use.聽The safety and effectiveness of neurostimulation for pediatric use have not been established.
External defibrillators.聽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).聽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 大秀视频 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.聽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.
贰濒别肠迟谤辞蝉耻谤驳别谤测.听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:
Implanted cardiac systems.聽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鈥檚 can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system
Emergency procedures.聽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.聽The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.
Therapeutic radiation.聽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.聽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.聽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.聽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.聽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.聽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.聽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.聽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.聽The use of components not approved for use by 大秀视频 Medical with this system may result in damage to the system and increased risk to the patient.
Device modification.聽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 大秀视频 Medical for service.
Application modification.聽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.聽Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.
IPG disposal.聽Return all explanted IPGs to 大秀视频 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.聽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.聽Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.
Patient selection.聽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.
滨苍蹿别肠迟颈辞苍.听Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.
Implantation of multiple leads.聽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.聽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.聽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.聽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.聽Store components and their packaging where they will not come in contact with liquids of any kind.
Handling and Implementation
Expiration date.聽An expiration date (or 鈥渦se-before鈥 date) is printed on the packaging. Do not use the system if the use-before date has expired.
Package or component damage.聽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 大秀视频 Medical for evaluation.
Handle the device with care.聽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.聽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.聽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.聽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.聽Do not use surgical instruments to handle the lead. The force of the instruments may damage the lead or stylet.
Component manipulation.聽Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space.
Stylet handling.聽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.聽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.聽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.聽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.聽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.聽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.聽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.聽Return all explanted components to 大秀视频 Medical for safe disposal. 聽
Hospital and Medical Environments
High-output ultrasonics and lithotripsy.聽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).聽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). 聽
Wireless use restrictions.聽In some environments, the use of wireless functions (e.g., Bluetooth庐 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庐 is a registered trademark of Bluetooth SIG, Inc.)
Security, antitheft, and radiofrequency identification (RFID) devices.聽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.聽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:
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.
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