PTRD2500
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Patient Manual
11052 Rev E ii
NEVRO CORP.
All questions or concerns about Nevro products should be forwarded to:
Nevro Corp.
1800 Bridge Parkway
Redwood City, CA 94065
USA
Tel: +1.650.251.0005
Fax: +1.650.251.9415
info@nevro.com
MDSS GMBH
Schiffgraben 41
D-30175 Hannover,
Germany
Australian Sponsor
Emergo Australia
Level 20, Tower II, Darling Park
201 Sussex Street, Sydney, NSW 2000
Australia
© Copyright 2019, Nevro Corp. All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored
in a retrieval system or translated into any language or computer language, in any
form or by any means, including, but not limited to, electronic, magnetic, optical,
chemical, manual, or otherwise without written permission of Nevro Corp.
Registered Trademarks: Senza, Senza II, Senza Omnia, HF10 and the HF10 logo,
and Nevro and the Nevro logo are trademarks of Nevro Corp.
CE Mark effective on 4 May 2010
Nevro hereby declares that the Senza® system is in compliance with the essential
requirements and other relevant provisions of the Radio Equipment Directive
(2014/53/EU).
IMPORTANT: Do not change or modify any component of the Nevro® Senza
system, unless expressly approved by Nevro Corp.
11052 Rev E iii
Explanation of symbols on the product or package labeling. Refer to the product
for symbols that apply.
Symbol Description
SN
Serial number
LOT
Batch code
Date of Manufacture
Manufacturer
Caution
Catalog number
Temperature limitation (storage)
www.nevro.com
Consult Electronic Instructions for Use
Non-sterile
Non-ionizing radiation
Type B Applied Part
Type BF Applied Part
Do not dispose of this product in the unsorted municipal waste
stream. Dispose of this product according to local regulations.
XX C
XXX F
XX C
XX F
11052 Rev E iv
Conditional
MR Conditional
MR unsafe
CE Marking of Conformity
Authorized representative in the European Community
For USA audiences only
0086
11052 Rev E v
Table of Contents
INTRODUCTION ...................................................................................... 1
ABOUT CHRONIC PAIN ........................................................................... 1
YOUR SENZA SYSTEM ............................................................................. 2
INDICATIONS ......................................................................................... 4
WARNINGS ............................................................................................ 4
WARNINGS ABOUT OTHER MEDICAL TREATMENTS ................................ 8
PRECAUTIONS ...................................................................................... 12
ADVERSE EVENTS ................................................................................. 15
WHAT TO EXPECT WITH SCS THERAPY .................................................. 17
TRIAL PHASE ........................................................................................ 17
How to Set Up and Use Your Equipment..................................................... 18
The Trial Stimulator ....................................................................................... 18
The Remote Control (RC1000) ....................................................................... 22
IMPLANTED STIMULATOR PHASE ......................................................... 28
How to Set Up and Use Your Senza Omnia™ Remote Control (RC2500 – 5
Program Remote) ...................................................................................... 28
Battery Status (CRG1000, RC1000, RC2500) ................................................ 35
Battery Level Indicators (CRG1000) ............................................................... 35
Battery Level Indicators (RC1000) ................................................................. 36
Battery Level Indicators (RC2500 – 5 Program Remote) ............................... 37
How to Charge the Implantable Pulse Generator ........................................ 37
How to Charge the Charger ........................................................................ 40
Optimizing Charging .................................................................................. 41
Charging Tips ............................................................................................. 41
YOUR PATIENT ID CARD ....................................................................... 43
ASK YOUR DOCTOR .............................................................................. 43
TROUBLESHOOTING ............................................................................. 44
Troubleshooting Therapy ........................................................................... 44
Troubleshooting the Remote Control (RC1000) ........................................... 44
Troubleshooting the Senza Omnia Remote Control (RC2500) ...................... 45
Troubleshooting the Trial Stimulator .......................................................... 46
Troubleshooting the Recharging Process .................................................... 46
All of the Lights are Blinking! ..................................................................... 47
11052 Rev E vi
APPENDICES ......................................................................................... 47
Device Specifications ................................................................................. 47
System Components .................................................................................. 54
11052 Rev E 1
INTRODUCTION
This booklet was written for people who are considering or have received a
Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. Every
person is unique and your medical needs differ from those of others, even people
with the same condition and the same SCS system. For this reason, always talk to
your doctor if you have questions about your condition. This booklet presents
general information and can help you better communicate with your doctor.
The first part of this booklet discusses chronic pain, spinal cord stimulation, and
the Senza system. It is based on common questions that patients have about
their condition, this particular treatment option, and the Senza system.
The second part of this booklet explains how to use the devices.
In the back of the booklet, we have added some information in the appendices.
The first appendix contains technical information about this product. This
information may be useful to you, but it is not necessary for you to understand it
in order to use your device. The second appendix shows pictures of the parts of
the Senza system.
Throughout the booklet, we have provided definition of medical or electronic
terms in a shaded box with a definition.
STIMULATION. Small electrical pulses produced by the SCS system delivered to
your spinal cord to provide therapy for your pain. Spinal cord stimulation is
sometimes called “therapy delivery.”
ABOUT CHRONIC PAIN
Everybody feels pain when there is a painful external stimulus such as a pinprick
or touching something hot. This is referred to as acute pain and is an important
normal sensation that helps protect against injury. Chronic pain is very different.
People with chronic pain may also feel pain when there is no obvious reason or
may have pain that does not go away long after an injury.
CHRONIC. Something that persists or lasts for more than 3 months. Chronic pain
is pain that does not go away with the passage of time or as the body heals from
an injury.
11052 Rev E 2
Chronic pain can be intractable, which is the medical term meaning that it is hard
to treat. You have probably tried many treatments to control your pain and found
that they did not work well or perhaps they did not work at all.
INTRACTABLE. Any condition, such as chronic pain, which is very difficult to
control or treat effectively.
YOUR SENZA SYSTEM
The Senza system works by delivering electrical energy from a device to an area
around your spine. The system is capable of delivering HF10® therapy, a therapy
that does not produce tingling sensations called paresthesia. It is also capable of
providing stimulation that produces paresthesia at some therapy settings. You
will first go through a trial phase where you and your doctor evaluate the
therapy to see if it is right for you. The Senza system trial phase consists of
several components:
• Trial Stimulator is a temporary device that you use outside the body to
test to see if the therapy is helpful to you.
• Lead is a thin insulated wire that connects to the Trial Stimulator at one
end and with small electrodes on the other end placed near your spine. A
small amount of electrical energy from the device travels through the
lead and near the spine.
• OR Cable is an insulated wire used outside the body to temporarily
connect the leads to the Trial Stimulator.
• Remote Control is a unit that can turn the stimulator ON or OFF and
allows for some adjustments of therapy settings.
PARESTHESIA. A sensation of tingling, “pins and needles,” prickling, or even
burning. Paresthesia may be brief or it may last a long time.
TRIAL PHASE. A time during which a person with chronic pain tests SCS therapy
to see if and how well it works. During the trial phase, the person will temporarily
use a Trial Stimulator, which is not implanted in the body.
11052 Rev E 3
If the Senza system is right for you, your doctor will discuss with you the
implantation of a battery-powered device after the trial phase. The Senza system
components will include:
• Implantable pulse generator (IPG) is a small, battery-powered electronic
device that is implanted inside the body (see IPG in the diagram above).
• Lead, same as in the trial phase. However, instead of connecting to an
external stimulator as occurred during the trial phase, will connect to the
implanted IPG. After implantation there are no external wires or
connections as occurred during the trial phase (see lead wires in diagram
above).
• Charger recharges the IPG after it is implanted.
• Power Adaptor recharges the Charger.
• Charger Belt and Charger Holster holds the Charger during recharging.
• Remote Control is a unit that can turn the IPG ON or OFF and allows for
some adjustments of therapy settings.
For pictures of the Charger, Power Adaptor, Charger Belt and Remote Control, please see the
“System Components” section at the end of this manual.
IMPLANTABLE PULSE GENERATOR or IPG. A self-contained battery-powered
device that is small enough to fit in a person’s hand and delivers small amounts of
electrical energy or pulses.
You will first use the Trial Stimulator and Remote Control. If the Senza system is
right for you, your doctor will then implant the IPG. You control the implanted
device with the same Remote Control.
11052 Rev E 4
INDICATIONS
The Senza system is not right for everyone. Indications for the use of this device
are as follows:
The Senza neuromodulation 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, intractable low
back pain, and leg pain.
INDICATIONS. Reasons that you should get a device, drug, or treatment.
Indications are determined by medical experts, clinical studies, and the Food &
Drug Administration (FDA).
CONTRAINDICATIONS
CONTRAINDICATIONS. Situations in which the device should not be used because
the risk of use clearly outweighs any possible benefit. Contraindications are
determined by medical experts, clinical studies, and the Food & Drug
Administration (FDA).
The Senza system is contraindicated (not appropriate) for certain patients.
Contraindications for the Senza system include:
• Not being able to operate the Senza system
• Not being able to have the SCS surgery
• Failing to receive effective pain relief during trial stimulation.
Your doctor can tell you if the Senza system might be appropriate for you. If you
have questions about whether the Senza system may be right for you, ask your
doctor.
WARNINGS
Warnings are statements about safety of your device that you should take very
seriously. If you do not follow these warnings, it is possible that you could be hurt
and/or the device could be damaged. The following are some warnings for the
Senza system:
Stimulation Frequencies – Stimulation frequencies in the range of 2 Hz to 1,200
Hz are indicated for paresthesia-based therapy and the system must be
configured to produce paresthesia. Stimulation at 10,000 Hz is indicated as
11052 Rev E 5
paresthesia-free therapy and the system must be configured to deliver
paresthesia-free stimulation. Stimulation between 1,200 Hz and 10,000 Hz has
not been evaluated for safety, effectiveness and perception of paresthesia.
Specifically, for stimulation frequencies above 1,200 Hz, amplitudes that produce
paresthesias have not been evaluated and therefore it is unknown whether injury
may occur.
Stimulation at vertebral levels above T8 – The safety of program settings above
1,200 Hz have not been studied above the T8 vertebral level.
Pediatric Use – The safety and effectiveness of spinal cord stimulation has not
been established for use in children.
Other Active Implanted Devices – Please let your doctor know if you have any
other active implanted devices in your body. The Senza system may interfere
with other implanted stimulators, such as cardiac pacemakers and defibrillators
which have sensing features, and may result in sensing problems or inappropriate
responses. The effect of other implanted devices, including deep brain
stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and
cochlear implants on the Senza system are unknown.
Sleep – If you are using therapy that generates paresthesia (tingling sensations
caused by stimulation) you may choose to turn stimulation off to avoid
uncomfortable sensations during sleep (see Warning regarding Stimulation
Frequency). If you are using therapy at 10 kHz which does not generate
paresthesia, stimulation can remain on during sleep.
Operation of Vehicles (e.g., driving) or Machinery – If you are using therapy that
generates paresthesia you should not operate motorized vehicles such as
automobiles or potentially dangerous machinery and equipment with the
stimulation on when using paresthesia-causing programs. Stimulation must be
turned off first in such cases. Any sudden stimulation changes may distract you
from proper operation of the vehicle, machinery, or equipment. If you are using
therapy at 10 kHz which does not generate paresthesia, it is less likely that
sudden stimulation changes resulting in distraction could occur.
11052 Rev E 6
Heat from Charging – You will have to recharge the battery in your device.
Always use the special Charger Belt when recharging. During recharging, the
Charging Coil may become warm or even burn you. If you feel warmth or
discomfort when recharging the device, stop recharging and contact your doctor.
Do not place the charger over an area of skin where you do not feel any
sensation.
Electromagnetic Interference (EMI) – Ordinary household appliances, magnets,
and devices encountered in everyday life will not affect your implanted Senza
device. However, some equipment generates electromagnetic interference (EMI)
which may affect your Senza system.
ELECTROMAGNETIC INTERFERENCE (EMI). Invisible signals generated by some
equipment, appliances, and devices, also known as noise or static. Even if you
cannot hear this noise, it may be picked up by your implanted SCS system and can
affect it.
Electromagnetic interference (EMI) can affect the implanted Senza system in
ways that are hard to predict. For example, EMI might:
• Turn your Senza system ON or OFF
• Cause your Senza system to give you more stimulation (a “shock”)
• Cause damage to the system that may result in loss of therapy and
require reoperation to replace the system
There are many sources of EMI today so it is not possible to give exact
instructions as to how to avoid them. Listed below are some well-known sources
of EMI that you should avoid:
• Power lines and power generators
• Arc welders
• Large, magnetized stereo speakers
• Radiofrequency identification devices (RFID)
Exposure to strong EMI can result in serious patient injury or death, resulting
from heating of the implanted components of the SCS system and damage to the
surrounding tissue.
The Remote Control, Charger and Trial Stimulator are suitable for use in a
residential environment (Per CISPR 11 class B).
11052 Rev E 7
WARNING: Use of the Senza system adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is
necessary, the Senza system and the other equipment should be observed to
verify that they are operating normally.
WARNING: Use of accessories other than those specified or provided by Nevro
could result in increased electromagnetic emissions or decreased
electromagnetic immunity of the Senza system and result in improper operation.
WARNING: Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 15 cm (6
inches) to any part of the Senza system, including cables specified by Nevro.
Otherwise, improper operation of the Senza system could result.
Theft Detectors and Security Screening Devices – Security checkpoints, metal
detectors, screening systems at airports, and theft detectors all produce EMI. If
you must pass through such a system, tell the personnel that you have an
implanted medical device and show them your patient ID card. They may be able
to help you get through the checkpoint without going through the scanner. If that
is not possible, you may be able to pass through the scanner or detector by
turning the device OFF and moving through the scanner as quickly as possible.
Theft detection systems may also produce EMI. While some theft detection
systems are obvious and are located at store exits, others may be concealed
within the store. If you are in a store or other environment and suspect EMI is
affecting your device, turn OFF the Senza system and move out of the area. Once
you are out of the area, check whether therapy is ON or OFF. You may have to
recharge the device. If you have specific questions about EMI sources, talk to
your doctor.
Strong electromagnetic fields arising from closeness to electrical equipment such
as mobile phones, satellite phones and radio systems may interfere with the
radio communication between the Remote Control and IPG. As described in the
“Troubleshooting” section of this manual, communication failure is indicated by
three beeps. Communication can be restored by moving away from the
interfering electrical equipment and retrying the operation.
Electrostatic Discharge (ESD) is a common source of electromagnetic interference
that can occur when a person or object accumulates a static charge. ESD is made
worse by low humidity and synthetic materials.
• If the battery terminals of the Trial Stimulator are exposed to ESD, the
device may reset and stop stimulation. Stimulation can be restarted by
following the instructions in the “How to Turn ON Stimulation” section of
11052 Rev E 8
this manual. To avoid unintentionally stopping stimulation, do not open
the battery compartment while stimulation is ongoing.
• ESD may cause the Charger to stop charging the IPG. If this happens,
charging can be resumed by repeating the steps in the “How to Charge
the Implantable Pulse Generator” section of this manual. ESD events can
be minimized by keeping the charger in the Charger Holster while
recharging the IPG.
WARNINGS ABOUT OTHER MEDICAL
TREATMENTS
Always tell your doctors, nurses, and other clinicians (including dentists, physical
therapists, occupational therapists, and others) that you have the Senza Spinal
Cord Stimulation system implanted in your body. There are some procedures that
are not recommended for people with the Senza system, and there are other
procedures which may be possible for you only with certain precautions. If you
ever need any of these treatments, be sure to discuss them with your pain doctor
as well as with the clinical team doing the procedure.
Procedures that are not recommended for you with an implanted SCS system
include:
• Diathermy
• Computed tomography (CT scans)
• Magnetic resonance imaging (MRI scans)
• Lithotripsy
• External defibrillation
• Ultrasound procedures
• Radiation
• Radio-Frequency or Microwave Ablation
DIATHERMY. A medical treatment in which heat energy from shortwaves,
microwaves, or ultrasounds are used as treatment or in surgery.
Diathermy Therapy - Energy from the diathermy device can be transferred to the
SCS system and can cause the lead to overheat, which may cause damage to the
device, heating and damage to the body, severe injury, and even death.
CT SCAN. A type of technology in which x-ray-like images are taken in sections
(slices) and then re-assembled by computer to provide detailed two- and three-
dimensional pictures of inside the body.
11052 Rev E 9
Computed Tomography (CT) – Please inform your doctor and medical personnel
conducting your CT scan that you have an implanted SCS system. You must turn
your device off temporarily while the scan is being conducted. It is important that
the person conducting your CT scan does the following:
• Determines the device type;
• If practical, tries to move external devices out of the scan range;
• Minimizes x-ray exposure to the implanted or externally worn
electronic medical device by:
o Using the lowest possible x-ray tube current consistent with
obtaining the required image quality; and
o Making sure that the x-ray beam does not dwell over the device
for more than a few seconds;
Important note: For CT procedures that require scanning over the medical device
continuously for more than a few seconds, as with CT perfusion or interventional
exams, attending staff should be ready to take emergency measures to treat
adverse reactions if they occur.
After CT scanning directly over the implanted or externally worn electronic
medical device:
• You should turn your Senza system device back on.
• Check that the Senza system is working properly.
• Contact your doctor as soon as possible if you suspect the Senza
system is not functioning properly after a CT scan.
MRI SCAN. A type of technology in which electromagnetic energy is used to take
images of soft tissue in the body.
Magnetic Resonance Imaging (MRI) - The Senza system is MR Conditional which
means that safety has been demonstrated only within specifically defined
conditions. Scanning under different conditions may result in severe injury,
death or device malfunction. If your doctor determines it is safe for you to have
an MRI, your doctor will have you turn off the device before the scan and turn it
back on when the scan is complete. This should be done with extreme caution,
since these scans may injure you or damage the device. Never undergo an MRI
scan without making sure the team doing the scan knows you have an SCS device.
If your doctor recommends an MRI, inform the doctor that you have the Senza
Spinal Cord Stimulation system and show him/her your patient ID card (refer to
Your Patient ID section in this manual). The doctor will need to take specific
11052 Rev E 10
precautions (as identified in the MRI Guidelines located at:
http://www.nevro.com/manuals
) to prevent patient injury and device damage.
Do not take the trial stimulator, patient remote, or charger into the MRI scan
room. They are not considered safe for MRI and may be rapidly pulled into the
MRI scanner. In doing so, they may strike and injure a person.
Before undergoing these or any other procedures, discuss them with your doctor
to be sure they are safe for you.
LITHOTRIPSY. The use of sound waves to help break up calcified stones in the
body.
EXTERNAL DEFIBRILLATION. The emergency use of two large paddles placed on
the chest to deliver a large amount of electrical energy to “re-start” the heart.
ULTRASOUND PROCEDURES. Any number of procedures that use sound waves to
get images of the soft tissue in the body.
RADIATION. The use of radiation energy for therapy. There are many types of
radiation treatments. Radiation can be as simple as an x-ray of the body or it can
be targeted therapy to kill cancer cells (radio therapy).
Lithotripsy, External Defibrillation, Ultrasound Procedures and Radiation - If you
are required to undergo lithotripsy, external defibrillation, high-output
ultrasound, radiation therapy, or ultrasonic scanning, inform the medical
personnel conducting the procedure that you have an implanted SCS system and
follow these precautions:
• Turn off the IPG before the procedure.
• Have medical personnel use the equipment as far away from the
IPG as possible.
• Have medical personnel keep fields, such as current, radiation, or
high-output ultrasonic beams, away from the IPG.
• Equipment should be set to the lowest energy setting possible.
• After the therapy or procedure, check to see that the IPG is
functioning properly by gradually increasing the IPG’s stimulation
to the desired level.
11052 Rev E 11
• If you suspect that the device is not functioning properly after
the use of these therapies or procedures, please contact your
doctor.
RADIO-FREQUENCY OR MICROWAVE ABLATION – An electrical current produced
by a radio/micro wave is used to heat up a small area of nerve tissue, thereby
decreasing pain signals from that specific area.
Radio-Frequency or Microwave Ablation – Safety has not been established for
Radio-Frequency or Microwave Ablation in people who have an implanted
neurostimulation system. Induced electrical currents may cause heating,
especially at the lead electrode site, resulting in tissue damage.
11052 Rev E 12
PRECAUTIONS
Precautions are instructions about your device you should follow to avoid
damage to the device, so that it will function correctly and last longer.
• Store the Trial Stimulator and Remote Control at normal temperatures in
the range of -20°C to 60°C (-4°F to 140° F).
• Store the Charger at normal temperatures in the range of 0°C to 45°C
(32°F to 113°F).
• The operating temperature range for the Patient Remote Control is 10°C
to 40°C (50°F to 104°F). The operating temperature range for the Trial
Stimulator is 10°C to 38°C (50°F to 100 °F). The operating temperature
range for the Charging System is 10°C to 40°C (50°F to 104°F).
• Keep the Charger, Trial Stimulator and Remote Control dry.
• Do not drop the Charger, Trial Stimulator and Remote Control. Although
these devices are built for constant use, they could break if dropped onto
a hard surface.
• Do not plug your Charger into a power source near water.
• Use only Nevro or Nevro-approved accessories with your Senza system.
Caring for the Trial Stimulator, Remote Control, and Charging System – You can
care for your Trial Stimulator, Remote Control, and Charger by cleaning them
with a soft, damp (not wet) cloth and mild detergent. Do not use alcohol or any
harsh or abrasive cleansers and never let moisture get inside these items.
Pregnancy and Nursing – This device is not to be used in pregnant/nursing
women, or women who may become pregnant.
Patient Activities – Some therapy settings are known to cause tingling sensations
(called “paresthesias”). With such settings, you may feel a sudden increase in
these sensations when you change your posture or make large or sudden
movements. You can lower the amplitude or turn off the stimulation before
making posture changes. If you are using stimulation at 10 kHz which does not
generate paresthesia, these postural changes should not affect you.
Patient Activities Related to Lead Movement – Do not make sudden and
excessive bending, stretching, or twisting movements, particularly within the first
11052 Rev E 13
weeks after the surgery. An implanted lead can move from its original location
during such movements, which might affect delivery of therapy. In such cases,
your system may need to be reprogrammed or the lead may need to be
repositioned through another operation.
Scuba Diving and Hyperbaric Chambers – Your Senza system is sensitive to high
pressure. To prevent possible damage to the device, prior to beginning these
activities turn OFF the Senza system and:
• Do not scuba dive to depths greater than 115 feet (35 meters)
• Do not enter a hyperbaric chamber with pressure above 4.5
atmospheres
HYPERBARIC CHAMBER. A special chamber or compartment in which 100%
oxygen is delivered to a person under very high pressures, far above the normal
atmospheric pressure. Hyperbaric therapy is used for some medical treatments,
such as wound healing.
Transcranial Magnetic Stimulation (TMS) and Electroconvulsive Therapy (ECT) –
Safety has not been established for TMS or ECT in people who have an implanted
neurostimulation system. Induced electrical currents may cause heating,
especially at the lead electrode site, resulting in tissue damage.
TMS. A non-invasive way that uses magnetic fields to stimulate nerve cells in the
brain.
ECT. A procedure in which electric currents are passed through the brain to
intentionally cause a seizure.
Transcutaneous Electrical Nerve Stimulation – Do not place transcutaneous
electrical nerve stimulation (TENS) electrodes so that the TENS current passes
over any part of the neurostimulation system. If you feel that the TENS may be
interfering with the implanted neurostimulator, discontinue using the TENS and
consult with your doctor.
TENS. A TENS unit is a device that sends small electrical currents to targeted body
parts. These currents are used to relieve pain.
Post-Operative Pain – In the days after the surgery, you may experience pain in
the implant area, which is typical in SCS surgeries.
11052 Rev E 14
IPG Location and Patient Manipulation – Do not to twist or rotate the IPG. If the
IPG flips over in the body, the Charger may not be able to charge the IPG.
Manipulation of the IPG in your body may cause the skin over the IPG to become
thinner over time.
Infection – If you experience persistent discomfort or excessive redness around
the wound areas, please advise your physician. You may need to be checked for
infection. Infections related to the SCS system may require the implanted
components to be explanted. Do not use the Charger if the incision is not
sufficiently healed. The Charger and the charging belt are not sterile and should
not be in contact with the incision.
Cell Phones – The impact of cell phones on the neuromodulation system is
unknown at this time.
IPG Failure – If your IPG does not provide stimulation even after complete
charging of the IPG or replacement of the batteries in the Patient Remote
Control, turn off the IPG and contact your physician. When frequency of
recharging becomes too inconvenient for you, the IPG may need to be replaced.
You should contact your physician if this occurs.
Device Disposal – If you want to dispose of any components in your system, it is
best to bring them back to your doctor. Do not throw them (or any electronic
components, including batteries) in the regular household trash. Your local
community will have regulations and advice as to how to dispose of batteries and
other components.
Never put these device components in fire as they may explode.
If an IPG and/or lead is ever removed from your body, your doctor will return it to
Nevro Corp. This helps Nevro monitor its products and is required by U.S. law.
In the event of death and cremation, the implanted IPG should be removed prior
to cremation.
Long-term effectiveness of neurostimulation – The long-term effectiveness of
spinal cord stimulation has been documented. Not all patients realize long-term
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