Abbott Eterna 32400 User manual

Eterna™ Implantable Pulse Generator
Model 32400
Clinician's Manual

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
WARNING: This product can expose you to chemicals including ethylene oxide, which is known to
the State of California to cause cancer and birth defects or other reproducve harm. For more
informaon, go to www.P65Warnings.ca.gov.
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‡ Indicates a third-party trademark, which is property of its respecve owner.
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Pat. hp://www.abbo.com/patents
© 2022 Abbo. All Rights Reserved.

Contents
Prescripon and Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indicaon for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Clinical Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
MRI Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Precauons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Adverse Eects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Product Descripon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Package Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Idenfying the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Direcons for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Creang a Generator Pocket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecng a Lead or Extension to the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Implanng the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Replacing the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Disposing of Explanted Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Checking the Status of the Generator Baery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Technical Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Appendix A: Product Specicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Storage and Excursion Temperature Specicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Product Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Generator Specicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Adapters and Extensions for Compability with Non-Abbo Leads. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Appendix B: System Components and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Generator Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Charging System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Charging System Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Programmers and Controllers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Programmer and Controller Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Leads and Extensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Leads and Extensions Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Adapters and Extensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Appendix C: Generator Baery Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Appendix D: Regulatory Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Disposal Guidelines for Baery-Powered Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Statement of FCC Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Idencaon Informaon for Product Registraon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Wireless Technology Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Quality of Service for Wireless Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Appendix E: Symbols and Denions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
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Prescripon and Safety Informaon
Read this secon to gather important prescripon and safety informaon.
Intended Use
The Eterna™ Spinal Cord Smulaon (SCS) 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
compable with the system.
Indicaon for Use
The Eterna™ SCS 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.
Contraindicaons
The Eterna™ SCS System is contraindicated for paents who are unable to operate the system or who have
failed to receive eecve pain relief during trial smulaon.
Clinical Studies
Clinical studies were conducted to assess the safety and eecveness of spinal cord smulaon (SCS)
systems. For informaon that supports the clinical use of neurosmulaon systems and the anatomical
placement of leads, refer to the clinical summaries manual for SCS.
MRI Safety Informaon
Some models of this system are Magnec Resonance (MR) Condional, and paents with these devices may
be scanned safely with magnec resonance imaging (MRI) when the condions for safe scanning are met.
For more informaon about MR Condional neurosmulaon components and systems, including
equipment sengs, scanning procedures, and a complete lisng of condionally approved components,
refer to the MRI procedures clinician's manual for neurosmulaon systems (available online at
medical.abbo/manuals). For more informaon about MR Condional products, visit the Abbo Medical
product informaon page at neuromodulaon.abbo/MRI-ready.
Warnings
The following warnings apply to this neurosmulaon system.
Poor surgical risks. Neurosmulaon should not be used on paents who are poor surgical candidates.
Neurosmulaon should not be used for paents with comorbidies that could prevent successful implant
or eecve therapy.
Magnec resonance imaging (MRI). Some paents may be implanted with the components that make up a
Magnec Resonance (MR) Condional 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
paent is eligible to receive an MRI scan by following the requirements provided by Abbo Medical.
Physicians should also discuss any risks of MRI with paents.
Paents without an MR Condional neurosmulaon system should not be subjected to MRI because the
electromagnec eld generated by an MRI may damage the device electronics and induce voltage through
the lead that could jolt or shock the paent.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeuc ultrasound
diathermy (all now referred to as diathermy) on paents implanted with a neurosmulaon system. Energy
from diathermy can be transferred through the implanted system and cause ssue damage at the locaon
of the implanted electrodes, resulng in severe injury or death.
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Diathermy is further prohibited because it may also damage the neurosmulaon system components. This
damage could result in loss of therapy, requiring addional surgery for system implantaon and
replacement. Injury or damage can occur during diathermy treatment whether the neurosmulaon system
is turned on or o.
Electrosurgery. To avoid harming the paent or damaging the neurosmulaon system, do not use
monopolar electrosurgery devices on paents with implanted neurosmulaon systems. If use of
electrocautery is necessary, place the neurosmulator in Surgery mode using the clinician programmer app
or the paent controller app before using an electrosurgery device.
During the implant procedure, if an electrosurgery device must be used, take the following acons:
▪Use bipolar electrosurgery only.▪
▪Place the neurosmulator in Surgery mode before using an electrosurgery device.
▪
▪Set the electrosurgery device to the lowest possible energy seng. Output power below 80 W is▪
recommended for all acvaons.
▪Complete any electrosurgery before connecng the leads or extensions to the neurosmulator.▪
▪Keep the current paths from the electrosurgery device as far from the neurosmulaon system as ▪
possible.
▪Exit Surgery mode during intraoperave tesng and aer the procedure is completed. ▪
NOTE: During intraoperave tesng, Surgery mode must be turned o for the neurosmulaon system
to funcon correctly.
▪Conrm that the neurosmulaon system is funconing correctly during the implant procedure, before ▪
closing the neurosmulator pocket, and aer the implant procedure.
Aer any surgery, check the neurosmulaon system for the following:
▪Check the neurosmulator to ensure Surgery mode has been turned o, even if Surgery mode was not ▪
turned on at the beginning or during the procedure.
▪Conrm the neurosmulaon system is funconing. ▪
Implanted cardiac systems. Physicians need to be aware of the risk and possible interacon between a
neurosmulaon system and an implanted cardiac system, such as a pacemaker or debrillator. Electrical
pulses from a neurosmulaon system may interact with the sensing operaon 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 neurosmulaon system, (1) maximize the distance between the
implanted systems; (2) verify that the neurosmulaon system is not interfering with the funcons of the
implanted cardiac system; (3) avoid programming either device in a unipolar mode (using the device’s can as
an anode) or using neurosmulaon system sengs that interfere with the funcon of the implantable
cardiac system.
Other acve implanted devices. The neurosmulaon system may interfere with the normal operaon of
another acve implanted device, such as a pacemaker, debrillator, or another type of neurosmulator.
Conversely, the other acve implanted device may interfere with the operaon of the neurosmulaon
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 acve implanted devices. Avoid placing equipment components directly over other electronic devices.
To correct the eect of interference with other devices, turn o the equipment or increase the distance
between the equipment and the device being aected.
Operaon of machines, equipment, and vehicles. Paents using therapy that generates paresthesia should
turn o smulaon before operang motorized vehicles, such as automobiles, or potenally dangerous
machinery and equipment because sudden smulaon changes may distract them from properly operang
it. However, current data shows that most paents using BurstDR™ smulaon therapy do not experience
paresthesia. For paents who do not feel paresthesia, sudden smulaon changes are less likely to occur
and distract them while operang motorized vehicles, machinery, or equipment.
Explosive and ammable gases. Do not use a clinician programmer or paent controller around explosive or
ammable gas fumes or vapors. This includes oxygen-enriched environments such as hyperbaric chambers.
Operang the device near gas fumes or vapors could cause them to catch re. If gas fumes or vapors catch
re, it could cause severe burns, injury, or death.
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Keep dry to avoid damage. Clinician programmers, paent controllers, and chargers are not waterproof.
Keep them dry to avoid damage. Advise paents to not use their devices when engaging in acvies that
might cause them to get wet, such as swimming or bathing.
Pediatric use. Safety and eecveness of neurosmulaon for pediatric use have not been established.
Pregnancy and nursing. Safety and eecveness of neurosmulaon for use during pregnancy and nursing
have not been established.
Device components. The use of components not approved for use by Abbo Medical with this system may
result in damage to the system and increased risk to the paent.
Device modicaon. This 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 Abbo Medical for service.
Applicaon modicaon. To prevent unintended smulaon, do not modify the generator soware in any
way. Only apply soware updates that are published directly by Abbo Medical.
Case damage. Do not handle the generator if the case is pierced or ruptured because severe burns could
result from exposure to baery chemicals.
Generator disposal. Return all explanted generators to Abbo Medical for safe disposal. generators contain
baeries as well as other potenally hazardous materials. Do not crush, puncture, or burn the generator
because explosion or re may result.
Product materials. Neurosmulaon systems have materials that come in contact or may come in contact
with ssue. A physician should determine whether or not a paent may have an allergic reacon to these
materials before the system is implanted.
Precauons
The following precauons apply to this neurosmulaon system.
General Precauons
Clinician training. Implanng physicians should be experienced in the diagnosis and treatment of chronic
pain syndromes and have undergone surgical and device implantaon training.
Paent selecon. It is extremely important to select paents appropriately for neurosmulaon. Thorough
psychiatric screening should be performed. Paents should not be dependent on drugs and should be able
to operate the neurosmulaon system.
Infecon. Follow proper infecon control procedures. Paents should avoid charging their generator over
an incision that has not completely healed. Infecons related to system implantaon might require that the
device be explanted.
Implantaon of two systems. If two systems are implanted, ensure that at least 20 cm (8 in.) separates the
implanted generators to minimize unintended interacon with other system components.
Implantaon of mulple leads. If mulple leads are implanted, leads and extensions should be routed in
close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnec energy that could
cause the paent unwanted smulaon.
Implant heang. While charging the generator, paents may perceive an increase in temperature at the
generator site. In paents who have areas of increased sensivity to heat, consider placing the implant
where the paent has normal sensaon.
High smulaon outputs. Smulaon at high outputs may cause unpleasant sensaons or motor
disturbances or render the paent incapable of controlling the generator. If unpleasant sensaons occur,
turn o smulaon immediately.
Electromagnec interference (EMI). Some equipment in home, work, medical, and public environments can
generate EMI that is strong enough to interfere with the operaon of a neurosmulaon system or damage
system components. Paents should avoid geng too close to these types of EMI sources, which include
the following examples: commercial electrical equipment (such as arc welders and inducon furnaces),
communicaon equipment (such as microwave transmiers and high-power amateur transmiers), high-
voltage power lines, radiofrequency idencaon (RFID) devices, and some medical procedures (such as
therapeuc radiaon and electromagnec lithotripsy).
Consumer goods and electronic devices. Magnec interference with consumer goods or electronic devices
that contain magnets, such as mobile phones and smart watches, may unintenonally cause the
neurosmulaon system to turn on or turn o or aect communicaon between the device and generator;
however, it will not change the prescribed programmed parameters. Paents should be advised to keep
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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 paent is concerned about a smart device interacng with
their neurosmulaon system, consider disabling magnet mode. For more informaon about seng the
magnet mode, refer to the clinician programmer manual or contact Technical Support.
Lead movement. Paents should be instructed to avoid bending, twisng, stretching, and liing objects
over 2 kg (5 lb) for six to eight weeks aer implantaon of a neurosmulaon system. Extension of the
upper torso or neck may cause lead movement and alter the smulaon eld (especially with leads in the
cervical area), resulng in oversmulaon or ineecve smulaon.
Paent training. Instruct paents to use their neurosmulaon system only aer an authorized clinician has
programmed the generator and has trained the paent on how to safely control smulaon and to charge
the system.
Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes
that may injure a paent.
Sterilizaon and Storage
Single-use, sterile device. The implanted components of this neurosmulaon 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 introducon into the sterile eld. 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 Implementaon
Expiraon date. An expiraon 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 implantaon, the generator should be charged prior to implantaon.
Handle devices with care. The clinician programmer and paent controller are sensive 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
implantaon. Excessive heat, excessive tracon, excessive bending, excessive twisng, 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, the device, or any device
components show signs of damage, tampering, or if the sterile seal is ruptured, or contaminaon is
suspected for any reason. Return any suspect components to Abbo Medical for evaluaon.
Exposure to body uids or saline. Exposure of the metal contacts, such as those on the connecon end of a
lead or extension, to body uids or saline prior to connecon can lead to corrosion. If such exposure occurs,
clean the aected parts with sterile, deionized water or sterile water for irrigaon, and dry them completely
prior to lead connecon and implantaon.
System tesng. To ensure correct operaon, always test the system during the implant procedure, before
closing the neurosmulator pocket, and before the paent leaves the surgery suite.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic
lithotriptor, may damage the electronic circuitry of an implanted generator. If lithotripsy must be used, do
not focus the energy near the generator.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage
to an implanted neurosmulaon system if used directly over the implanted system.
External debrillators. Safety for use of external debrillator discharges on a paent receiving
neurosmulaon has not been established. External debrillaon can cause induced currents in the lead-
extension poron of the neurosmulaon system. Aer debrillaon, conrm the neurosmulaon system
is sll working.
Therapeuc radiaon. Therapeuc radiaon may damage the electronic circuitry of an implanted
neurosmulaon system, although no tesng has been done and no denite informaon on radiaon
eects is available. Sources of therapeuc radiaon include therapeuc X rays, cobalt machines, and linear
accelerators. If radiaon therapy is required, the area over the implanted generator should be shielded with
lead. Damage to the system may not be immediately detectable.
4

Home and Occupaonal Environments
Security, anthe, and radiofrequency idencaon (RFID) devices. Some anthe devices, such as those
used at entrances or exits of department stores, libraries, and other public places, and airport security
screening devices may aect smulaon. Addionally, RFID devices, which are oen used to read
idencaon badges, as well as some tag deacvaon devices, such as those used at payment counters at
stores and loan desks at libraries, may also aect smulaon. Paents who are implanted with nonadjacent
mulple leads and paents who are sensive to low smulaon thresholds may experience a momentary
increase in their perceived smulaon, which some paents have described as uncomfortable or jolng.
Paents should cauously approach such devices and should request help to bypass them. If they must go
through a gate or doorway containing this type of device, paents should turn o their generator and
proceed with cauon, being sure to move through the device quickly.
Scuba diving or hyperbaric chambers. Before diving or using a hyperbaric chamber, paents should contact
their physician to discuss the eects of high pressure on their implanted system. Implanted systems with
non-Abbo leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Paents
with implanted Abbo leads should avoid scuba diving in more than 30 m (100 ) of water or entering
hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of me, as this may damage the
neurosmulaon system. For less than 30 m (100 ) of water or pressures below 4.0 ATA, duraons of less
than 60 minutes are recommended.
Wireless use restricons. In some environments, the use of wireless funcons (for example, Bluetooth®
wireless technology) may be restricted. Such restricons may apply aboard airplanes, near explosives, or in
hazardous locaons. If you are unsure of the policy that applies to the use of this device, please ask for
authorizaon to use it before turning it on.
Adverse Eects
In addion to those risks commonly associated with surgery, the following risks are associated with using
this neurosmulaon system:
▪Unpleasant sensaons or motor disturbances, including involuntary movement, caused by smulaon▪
at high outputs (If either occurs, turn o your generator immediately.)
▪Undesirable changes in smulaon, which may be related to cellular changes in ssue around the▪
electrodes, changes in electrode posion, loose electrical connecons, or lead failure
▪Smulaon in unwanted places (such as radicular smulaon of the chest wall) ▪
▪Lead migraon, causing changes in smulaon or reduced pain relief▪
▪Epidural hemorrhage, hematoma, infecon, spinal cord compression, or paralysis from placement of a▪
lead in the epidural space
▪Cerebrospinal uid (CSF) leakage▪
▪Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant▪
▪Persistent pain at the electrode or generator site ▪
▪Seroma (mass or swelling) at the generator site▪
▪Allergic or rejecon response to implant materials▪
▪Implant migraon or skin erosion around the implant ▪
▪Baery failure▪
System Overview
This neurosmulaon system is designed to deliver electrical smulaon to nerve structures. The
neurosmulaon system includes the following main components:
▪Generator and accessories▪
▪Charger and accessories▪
▪Leads▪
▪Clinician programmer applicaon on clinician programmer device ▪
▪Paent controller applicaon on paent controller device ▪
▪Paent magnet
▪
5

The implantable pulse generator (also referred to as an IPG or neurosmulator) delivers electrical pulses
through the leads to electrodes near selected nerve bers in order to provide therapeuc smulaon. The
paent magnet can turn the generator on and o if the physician enables this funconality.
Physicians use the clinician programmer to create and modify programs for a paent, view and email
program log les, and view generator and charger informaon. Paents use the paent controller to control
their prescribed programs, monitor generator baery status to maintain smulaon, monitor charging
status, and modify charger sengs. Paents use the charger to charge their generator.
NOTE: In this document, the term "clinician programmer" refers to the Abbo Medical Clinician Programmer
device, "paent controller" refers to the Abbo Medical Paent Controller device, "clinician programmer
app" refers to the Abbo Medical Clinician Programmer soware applicaon (app), and "paent controller
app" refers to the Abbo Medical Paent Controller app.
The following image shows how the major system components are intended to interact.
Figure 1. Interacon among main system components
1. Clinician programmer1.
2. Charger2.
3. Paent controller3.
4. Generator4.
5. Leads/Extensions/Adapters5.
6. Magnet6.
indicates devices communicate through
Bluetooth® wireless technology
NOTE: This manual provides instrucons for implanng the generator. For instrucons for using other
components or more informaon about the neurosmulaon system, see the applicable manuals for those
components.
Product Descripon
This implantable pulse generator is a rechargeable electronic device designed to be connected to one or
more extensions or leads with up to 16 electrodes total. It is powered by a hermecally sealed rechargeable
baery within a tanium case and uses microelectronic circuitry to generate constant-current electrical
smulaon. The generator can deliver smulaon with a single program or with mulple programs. Each
program can provide smulaon to a single anatomical area or to mulple areas. The generator
communicates wirelessly with the clinician programmer and the paent controller and receives radio
frequency energy from an external charger to charge the generator baery.
Addional funcons supported:
▪Upgradeability. Soware upgrades aer implantaon provide paents with addional features as▪
approved by the respecve regulatory agencies. To upgrade features on the generator, a clinician
programmer or paent controller is needed.
▪Compability. The generator header is designed to allow the generator to connect to an Abbo adapter ▪
so compable leads or extensions from another manufacturer can be used with the Eterna™ SCS
system. Refer to the compability guidelines in this manual (see “Adapters and Extensions for
Compability with Non-Abbo Leads” (page 12)).
6