Spinal Modulation orporated MN0200 Implantable Neurostimulator User Manual LP0275 Rev B September 2011

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TM
Axium™ Neurostimulator System
Physician Implant Manual
Spinal Modulation, Inc.
1135 O’Brien Drive
Menlo Park, CA 94025
USA
Copyright © September 2011 by Spinal Modulation, Inc. All Rights Reserved. No portion of this manual may be reproduced or
transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information
storage and retrieval systems, without the express written permission of Spinal Modulation, Inc.
LP0275 Rev B, September 2011
Spinal Modulation, Inc.
Physician Implant Manual
Contents
Explanation of Symbols on Product or Package Labeling ................................................. 4
INTRODUCTION ............................................................................................................................ 5
System Overview ............................................................................................................ 6
Indications for Use .......................................................................................................... 7
Contraindications............................................................................................................ 7
SYSTEM DESCRIPTION .................................................................................................................... 7
Trial Neurostimulator (TNS) ............................................................................................ 9
Implantable Neurostimulator (INS) ................................................................................. 9
Implant Leads / Trial Leads / Lead Extension..................................................................10
Connector Cable Kit .......................................................................................................10
Lead Accessories ............................................................................................................10
Implantation Tools.........................................................................................................11
Additional Accessories ...................................................................................................11
Clinical Programmer and Patient Programmer ...............................................................11
Sterilization Information ................................................................................................12
Storage Conditions.........................................................................................................12
Product Materials ..........................................................................................................12
SAFETY INFORMATION ..................................................................................................................13
•
General Warnings .................................................................................................13
•
Warnings – For Use in Home or Work Environments .............................................15
•
Precautions ...........................................................................................................16
Adverse Events ..............................................................................................................17
IMPLANTING THE NEUROSTIMULATOR SYSTEM ...................................................................................18
•
Precautions for the Implant Procedure .................................................................18
Selection of Neurostimulator Trial Approach .................................................................19
Preparing the Patient and Devices for Use .....................................................................20
Placing the Lead .............................................................................................................20
Intraoperative Testing....................................................................................................25
Removing the Delivery System Components – Percutaneous Lead Trial.........................26
Lead Anchoring – Percutaneous Lead Trial .....................................................................28
Neurostimulation Trial –Percutaneous Lead Trial...........................................................28
Removing Trial Lead –Percutaneous Lead Trial ..............................................................29
Removing the Delivery System Components – Implant Lead Trial Only ..........................29
Lead Anchoring ..............................................................................................................31
Spinal Modulation, Inc.
Physician Implant Manual
Percutaneous Extension Tunneling – Implant Lead Trial Only ........................................32
Removing Lead Extension – Implant Lead Trial Only ......................................................33
Creating the INS Pocket – Implant..................................................................................34
Lead or Extension Tunneling ..........................................................................................35
Connecting Lead to Extension ........................................................................................35
Connecting the INS.........................................................................................................36
Implanting the INS .........................................................................................................37
Checking System Integrity ..............................................................................................38
Completing the Procedure .............................................................................................38
REPLACING AN INS ......................................................................................................................38
Disposing of an Explanted Device...................................................................................39
APPENDIX A: TRIAL LEAD KIT / IMPLANT LEAD KIT .............................................................................40
How Supplied.................................................................................................................40
Package Contents...........................................................................................................40
Device Specification .......................................................................................................41
APPENDIX B: TRIAL NEUROSTIMULATOR ..........................................................................................42
Device Description .........................................................................................................42
Package Contents...........................................................................................................42
Device Specifications .....................................................................................................42
Handling ........................................................................................................................43
APPENDIX C: IMPLANTABLE NEUROSTIMULATOR ................................................................................44
How Supplied.................................................................................................................44
Device Description .........................................................................................................44
Package Contents...........................................................................................................44
Device Specifications .....................................................................................................44
Handling ........................................................................................................................45
Device Longevity ............................................................................................................45
COMPANY AND AUTHORIZED REPRESENTATIVE CONTACT INFORMATION ..................................................46
ii
Spinal Modulation, Inc.
Physician Implant Manual
Explanation of Symbols on Product or Package Labeling
Model Number
Lot Number
Consult Instructions for Use
Read the Manual
Do not resterilize
Single Use Only
Sterilized by Ethylene Oxide Gas
Use By YYYY‐MM
Open sterile pouch by peeling pouch corner
Open sterile tray by peeling tray corner
Manufacturer
Manufacturing Date
Warning
Standby
Caution
Not waterproof
Applies to the Programmer when it is not in its carrying case
Spinal Modulation, Inc.
Physician Implant Manual
Limited waterproof. Applies to the TNS
Applies to the Programmer in its carrying case
Contents of Package are Non‐Sterile
Keep Dry
Storage temperature
Store between 10% and 90% humidity
Sterile Components
Store between 0% and 93% humidity
TNS and Programmers
The device is a radio transmitter
Magnet. Shows the location of the Programmer magnet.
Authorized European Representative
RF Operating Frequencies. Nearby equipment emitting strong magnetic fields can interfere with
RF communication, even if the other equipment complies with CISPR emission requirements. The
operating characteristics are as follows:
MICS/MedRadio band: 402‐405 MHz. The effective radiated power is below the limits as
specified in
Europe: EN ETSI 301 839‐2
USA FCC 47 CFR Part 95; 95.601‐95.673 Subpart E, 95.1201‐95.1219
FCC ID: Y8L‐MN0200
This device may not interfere with stations operating in the 400.150–406.000 MHz band in the
Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must
accept any interference received, including interference that may cause undesired operation.
Introduction
This manual describes the Axium™ Neurostimulator System, including instructions for
implantation. For detailed operation and clinical programming instructions, refer to the Clinical
Programmer Manual.
Spinal Modulation, Inc.
Physician Implant Manual
System Overview
The Axium™ Neurostimulator System consists of an Implantable Neurostimulator (INS) device,
Trial Neurostimulator (TNS) device, a Clinical Programmer, a Patient Programmer, one or more
leads which may be used in combination with a lead extension and the accessories and tools
used for implanting the system. The TNS or INS is connected to leads placed within the epidural
space near the dorsal root ganglion (DRG). Up to four leads may be placed and connected to
the neurostimulator to provide stimulation.
Patients who are indicated for the Axium™ Implantable Neurostimulator (INS) System will first
undergo a temporary trial period using an external Trial Neurostimulator (TNS) System
connected to implanted leads. If both the clinician and patient believe that sufficient pain relief
was achieved, then the patient will be scheduled for an implant, in which the INS will be
implanted.
NOTE: In this manual the general abbreviation “NS” is used for information which applies to
both TNS and INS. In all other cases the specific abbreviations “TNS” or “INS” are used.
Spinal Modulation, Inc.
Physician Implant Manual
Indications for Use
The Axium™ Neurostimulator System is indicated as an aid in the management of chronic
intractable pain of the trunk and/or limbs.
Contraindications
Patients contraindicated for the Axium™ Neurostimulator System are those who:
•
Have an active implantable medical device including but not limited to cardiac
pacemakers and cardiac defibrillators
•
Are unable to operate the system
•
Are poor surgical risks
•
Are pregnant
•
Are under the age of 18
System Description
The Axium™ Neurostimulator System consists of the following components:
Component
Name
Model
Numbers
Package Content
Instructions for Use
Trial
Neurostimulator
MN10100
MN20100
• Trial Neurostimulator
Trial Neurostimulator
Manual
Implantable
Neurostimulator
MN10200
MN20200
•
•
•
•
•
Implantable Neurostimulator
Lead Port Plugs (3)
Torque Wrench
Sterile Magnet Sleeve
Medical Alert Card
Physician Implant
Manual
Trial Lead Kit
MN10350‐XX
MN20350‐XX
•
•
•
•
•
•
•
Trial Lead
22 cm Small Curve Delivery Sheath
22 cm Big Curve Delivery Sheath
Guidewire
Complex Curved Stylet
4.5” 14G Delivery Needle
Soft Tissue Anchor (2)
Physician Implant
Manual
(length in cm
specified by ‐XX)
Spinal Modulation, Inc.
Physician Implant Manual
Component
Name
Model
Numbers
Package Content
Instructions for Use
Implant Lead Kit
MN10450‐XX
MN20450‐XX
•
•
•
•
•
•
•
Physician Implant
Manual
Connector Cable
Kit
MN11350
MN21350
• Connector Cable
• Lead Identifiers (3)
Physician Implant
Manual
Tunneling Tool Kit
30 /51 cm
MN11900
MN21900
•
•
•
•
•
•
•
Tunneling tool 30/51 cm
Straw
Trocar Tip
Pencil Tip
INS Sizer
Port Plugs (3)
Torque Wrench
Physician Implant
Manual
(length in cm
specified by ‐XX)
MN12200
MN22200
Implant Lead
22 cm Small Curve Delivery Sheath
22 cm Big Curve Delivery Sheath
Guidewire
Complex Curved Stylet
4.5” 14G Delivery Needle
Soft Tissue Anchor (2)
Clinical
Programmer
MN10700
MN20700
•
•
•
•
Clinical Programmer
External Magnet
Programmer Charger
Carrying Case
Clinical Programmer
Manual
Patient
Programmer
MN10600
MN20600
•
•
•
•
•
Patient Programmer
External Magnet
Programmer Charger
Carrying Case
Medical Alert Card
Patient Programmer
Manual
Auxiliary Magnet
Kit
MN13300
MN23300
•
Auxiliary Magnet
Ancillary Items Manual
Programmer
Charger Kit
MN13400
MN23400
•
Programmer Charger
Ancillary Items Manual
Programmer
Carrying Case
MN13500
MN23500
• Programmer Carrying Case
Ancillary Items Manual
Lead Accessories
Kit
MN12050
MN22050
•
•
•
•
•
•
Physician Implant
Manual
4.5” 14G Delivery Needle
6.0” 14G Delivery Needle
Soft Tissue Anchor
Complex Curved Stylet
30 cm Big Curve Delivery Sheath
30 cm Small Curve Delivery Sheath
Spinal Modulation, Inc.
Component
Name
Physician Implant Manual
Package Content
Instructions for Use
22 cm Small Curve MN12150
Delivery Sheath Kit MN22150
•
22 cm Small Curve Delivery Sheaths (2)
Physician Implant
Manual
22 cm Big Curve
MN13650
Delivery Sheath Kit MN23650
•
22 cm Big Curve Delivery Sheaths (2)
Physician Implant
Manual
4.5” Needle Kit
MN11700
MN21700
•
4.5” 14G Delivery Needle
Physician Implant
Manual
Lead Extension Kit
MN10550‐XX
MN20550‐XX
• Lead Extension 50 cm
• Torque Wrench
(length in cm
specified by ‐XX)
Model
Numbers
Physician Implant
Manual
Trial Neurostimulator (TNS)
The external TNS device connects to the Trial Lead(s) or Lead
Extensions and is worn by the patient for up to 30 days during
the trial period. The TNS device has a belt clip for the patient’s
convenience.
Implantable Neurostimulator (INS)
The Axium™ Implantable Neurostimulator (INS) is a non‐rechargeable, 4 channel electronic
device. It uses microelectronic circuitry, powered by a hermetically sealed battery, to generate
a pulsed waveform to stimulate neural tissue. The electronic circuitry and battery are housed
in a hermetically sealed titanium case.
Each neurostimulator has a unique internal identifier that allows the physician to identify the
type of device through an X‐ray. The radiopaque identifier inside the case allows identification
of both the device manufacturer and model number using standard x‐ray equipment. For the
Axium™ Neurostimulator, the code is SM001 which identifies Spinal Modulation as the
manufacturer and MN10200 / MN20200 as the model number.
Spinal Modulation, Inc.
Physician Implant Manual
The INS is packaged in a sealed inner tray within a sealed outer tray.
Implant Leads / Trial Leads / Lead Extension
The Lead Kits contain the Leads and the individual delivery devices that are required for their
placement.
CAUTION: The temporarily placed Trial Leads are intended for use for up to 30 days.
•
Implant / Trial Leads: The Leads are designed for percutaneous introduction into the body
using a special needle and a set of custom delivery tools provided in their respective kits.
Each Lead is fitted with four cylindrical electrodes spaced at equal intervals which are
intended to provide stimulation at the target dorsal root ganglion (DRG). Each Lead is
packaged with a Complex Curved Stylet inserted into the Lead and the Lead is pre‐loaded
into a 22 cm Small Curve Delivery Sheath for the physician’s convenience.
•
Lead Extension: The Lead Extension consists of a silicone port header that accepts the
Spinal Modulation Trial Lead and Implant Lead. It is intended to extend the length of the
lead and provide a connection between the lead and the Connector Cable or the lead and
the Implantable Neurostimulator System. The Lead Extension is intended for chronic
implantation as a component of the Axium™ Neurostimulator System.
Connector Cable Kit
The Connector Cable connects the Leads or Lead Extension to the external TNS.
•
Connector Cable: The Connector Cable is packaged separately from the Lead and Lead
Extension Kit. The Connector Cable includes a connector and 2 extension cables for use
as needed.
•
Lead Identifiers: The Lead Identifiers are small bent wires that can be inserted into the
proximal stylet lumen in the leads and are individually colored to identify the leads.
Lead Accessories
•
Small / Big Curve Delivery Sheath: The Delivery Sheaths are intended to allow passage of
the lead percutaneously into the epidural space. The labeled length of the sheath is the
distance from the hub to the pre‐shaped tip and the length of the curve at the tip is
approximately 2 mm for the Small Curve and approximately 8mm for the Big Curve.
•
Complex Curved Stylet: The Complex Curved Stylet is intended to assist in steering and
positioning the lead within the epidural space. The Complex Curved Stylet has been pre‐
inserted into the Lead for the physician’s convenience.
•
14G Delivery Needles: The Delivery Needle is intended to access the epidural space,
providing a conduit for lead, guidewire and delivery sheath placement.
•
Guidewire: The Guidewire is intended to verify that the needle is in the epidural space
after using a loss of resistance technique.
10
Spinal Modulation, Inc.
•
Physician Implant Manual
Soft Tissue Anchor: The Soft Tissue Anchors are intended to anchor the Lead in the soft
tissue or on the skin surface proximal to the distal contacts of the Lead.
Implantation Tools
•
Tunneling Tool: The tunneling tool is used to provide a conduit for the Trial Lead, Implant
Lead, or Lead Extension to the INS or away from the midline of the spine. It is packaged
with 2 exchangeable tips: a blunt pencil tip and a sharp trocar tip. A straw is slid over the
tunneling tool and when the steel handle is removed, the straw provides the conduit for
tunneling.
•
INS Sizer: The INS Sizer is approximately the same size as the INS and allows the physician
to properly size the INS pocket.
Port Plugs: The port plugs are used to fill unused ports in the INS. They are packaged with
the INS, but spare port plugs are also packaged with the Tunneling Tool Kits for the
convenience of the physician
•
Additional Accessories
•
Sterile Magnet Sleeve: The magnet is placed in the sterile sleeve to allow it to be used
during the implantation of the INS.
•
Medical Alert Card: Identifies the patient as a user of the Neurostimulation System.
•
Programmer Charger: To be used with the Clinical or Patient Programmers to charge the
battery or allow use of the Programmers while plugged into standard electrical outlets.
•
Programmer Carrying Case: Protects the Programmers from water.
•
Auxiliary Magnet: Allows the user to the turn the NS off or activates RF to allow the user to
communicate with the NS.
Clinical Programmer and Patient Programmer
Two programmers are available to interact with the NS device.
1. The Clinical Programmer is used to program the
stimulation parameters for both the TNS and
the INS. The instructions for programming the
TNS and INS devices are the same. The Clinical
Programmer is used by the physician or clinical
staff.
2. The Patient Programmer allows the patient to
adjust the stimulation settings of the TNS and
INS devices within limits preset by the clinician.
The Patient Programmer also allows the patient
to turn stimulation off, if necessary.
11
Spinal Modulation, Inc.
Physician Implant Manual
Note: For detailed information and instructions related to the Clinical and Patient
Programmer and the Trial Neurostimulator, refer to the respective user manuals.
Sterilization Information
Single‐use, sterile device ‐ The sterile components of the Axium™ Neurostimulator System are
provided sterile in a double pouch or tray assembly and are intended for single use only. An
expiration date (or “use‐before” date) is marked on the label of each package. Use proper
sterile techniques to open the packaging.
WARNING: Do not resterilize or reuse any devices for any reason because of risk of
infection to the subject and malfunction of the devices.
Sterilization – The Spinal Modulation INS, Trial Lead Kit, Implant Lead Kit, Lead Extension Kit,
Lead Accessories Kit and Tunneling Tool Kits have been sterilized using ethylene oxide (EO) gas.
Storage Conditions
Store all sterile product including the INS, Leads, and Lead Accessories Kits as follows:
Storage Temperature – Store components between 14°F (‐10°C) and 122°F (50°C).
Temperatures outside this range may damage the components. If a temperature deviation has
occurred, do not use the product.
Storage Humidity –Store components between 10% and 90% humidity.
Storage Environment – Store components and their packaging where they will not come in
contact with liquids of any kind.
Product Materials
Portions of the Axium™ Neurostimulator System will come in contact with bodily tissues.
WARNING: Neurostimulation systems have materials that 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.
The following materials are implanted and come in contact with tissue:
•
•
•
•
•
Platinum iridium
Polyurethane
Titanium
Epotek
Silicone rubber
•
•
•
•
•
Stainless Steel
MP35N (nickel‐cobalt‐chromium‐molybdenum alloy)
PEEK (polyether ether ketone)
PFA (perfluoroalkoxy copolymer resin)
PMMA [poly(methyl methacrylate)]
12
Spinal Modulation, Inc.
Physician Implant Manual
Safety Information
General Warnings
The following warnings apply to the use of the Axium™ Neurostimulator System:
•
External Defibrillators – Safety for use of external defibrillator discharges on a patient
receiving neurostimulation has not been established.
•
Magnetic Resonance Imaging – The patient should be advised to not undergo any
elective magnetic resonance imaging (MRI) with the system in place. Use of MRI in the
vicinity of the lead(s) may result in forceful dislodgment of the lead(s), or damage to the
Neurostimulator. If a voltage is induced through the lead, it may cause uncomfortable
(“jolting” or “shocking”) levels of stimulation or injury to the patient.
•
Ultrasonic Scanning – Ultrasonic equipment may cause mechanical damage to the lead
if used directly over the site.
•
Electrosurgery Devices – Electrosurgery devices should not be used in close proximity to
implanted lead(s). Contact between an active lead and the electrosurgical pencil can
cause direct stimulation of the contacted nerve and can cause severe injury to the
patient. Electrosurgery devices may also damage the lead and cause a loss of
stimulation.
•
Pediatric Use – Use of neurostimulation has not been approved specifically for children
less than 18 years of age.
•
Pregnancy – Safety and effectiveness of neurostimulation for use during pregnancy and
nursing have not been established.
•
Non‐Emergency Procedures –The patient must be advised that they must not have non‐
emergency procedures while they are undergoing trial stimulation.
•
Emergency Procedures – The patient should be instructed to designate a representative
(family member or close friend) to notify any emergency medical personnel of their
neurostimulator implant, if emergency care is required. Each patient also will be
provided with a Medical Alert Card to carry with them that will inform emergency
medical personnel of the patient’s implant. The patient should be advised to use
caution when undergoing any procedure that could include RF or microwave ablation,
defibrillation or cardio version.
•
Routine Medical Procedures – The patient should be instructed to not to undergo
dental procedures, diathermy, electrolysis, diagnostic ultrasound, static field
therapeutic magnets, diagnostic X‐ray, and high output ultrasonic lithotripsy. These
procedures may provide interference that can affect TNS or INS device operation or use
or damage components of the system that may cause patient harm.
13
Spinal Modulation, Inc.
Physician Implant Manual
If the patient with an INS or TNS device is subsequently given any medical treatment in
which an electrical current is passed through his/her body from an external source,
either the device should first be deactivated, or care should be taken to monitor the
functioning of the neurostimulator during the initial stages of treatment.
•
Diathermy Therapy – Do not use short‐wave diathermy, microwave diathermy, or
therapeutic ultrasound diathermy (all now referred to as diathermy) on patients
implanted with a neurostimulation system. Energy from diathermy can be transferred
through the implanted system and cause tissue damage at the location of the implanted
electrodes, resulting in severe injury or death. Diathermy is further prohibited because
it may also damage the neurostimulation system components. This damage could result
in loss of therapy, requiring additional surgery for system implantation and
replacement. Injury or damage can occur during diathermy treatment whether the
neurostimulation system is turned on or off. All patients are advised to inform their
health care professionals that they should not be exposed to diathermy treatment.
•
Cardiac Pacemakers and Implantable Cardiac Defibrillators (ICD) – It is possible that the
device may affect the operation of other implantable devices such as pacemakers or
implantable cardiac defibrillators. The physician should be aware of any other
implantable devices the patient may have or is scheduled to receive.
•
Explosive or Flammable Gases – Do not use the patient programmer or clinical
programmer to communicate with the INS or TNS in an environment where explosive or
flammable gas fumes or vapors are present. The operation of the programmer could
cause them to ignite, causing severe burns, injury, or death.
•
Case Damage – If the INS case is pierced or ruptured, an explosion can occur from the
battery chemicals, which can lead to severe burns or even death.
•
Device Components – The use of non Spinal Modulation components with the system
may result in damage to the system and increased risk of harm to the patient.
•
Component Disposal – Return all explanted Neurostimulators to Spinal Modulation for
safe disposal. Do not crush, puncture, or burn the Neurostimulator because explosion
or fire may result.
•
Exposure to Fluids – Exposure of the external TNS or the Connector Cable to water,
body fluids, saline, or cleaning agents can cause corrosion and affect stimulation. If this
occurs, dry all components thoroughly prior to lead connection. Do not immerse the
external TNS or Connector Cable in fluids.
•
Device Handling ‐ The patient must be instructed to not remove their Trial Lead(s) or
Connector Cable. Manipulation of the components may result in an undesired outcome,
such as the patient developing an infection, getting undesirable stimulation, or
accidentally turning their stimulation off. The patient must be instructed to not rub or
exert pressure on the implantable neurostimulator through the skin as this may cause:
lead dislodgement leading to stimulation at the implant site, device inversion leading to
the inability to communicate with the device, or skin erosion that can lead to another
surgical procedure or possible infection.
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Spinal Modulation, Inc.
Physician Implant Manual
Warnings – For Use in Home or Work Environments
•
Equipment Operation – During stimulation, patients should be advised to not operate
potentially dangerous equipment, such as power tools, automobiles, or other motor
vehicles. They should not climb ladders or participate in other activities where postural
change or an abrupt movement could alter the perception of stimulation intensity and
cause patients to fall or lose control of equipment or vehicles or injure others.
•
Patient Activity – Patients should be advised to limit their activities to low or moderate
levels during their trial stimulation period and the first six weeks of implantation of the
INS. Failure to do so may result in migration of the leads causing loss of stimulation
therapy, muscle stimulation or painful stimulation thereby requiring reoperation to
reposition.
•
Theft Detectors and Metal Screening Devices – Certain types of antitheft devices, such
as those used at entrances/exits of department stores, libraries, and other public
establishments, and/or airport security screening devices may affect stimulation. It is
possible that patients who are implanted with non‐adjacent multiple leads and/or
patients who are sensitive to low stimulation thresholds may experience a momentary
increase in their perceived stimulation, which has been described by some patients as
uncomfortable or jolting. It is recommended that patients use caution when
approaching such a device and that they request assistance to bypass the device. If they
must proceed through the device, patients should turn off the NS and proceed with
caution, being sure to move through the detector quickly.
•
Restricted Areas – The patient should be warned to seek medical guidance before
entering environments which could adversely affect the operation of the implanted
device, including areas protected by a warning notice preventing entry by patients fitted
with a pacemaker.
•
Electromagnetic Interference (EMI) – Certain commercial equipment such as resistance
welders and induction furnaces, certain communication equipment such as microwave
transmitters, linear power amplifiers, and high voltage power lines may generate
sufficient EMI to interfere with the INS and TNS System resulting in understimulation,
overstimulation, or difficulty in device communications. Certain medical devices may
also cause EMI interference and make it difficult to communicate with the INS or TNS;
such devices include bone growth stimulators, transcutaneous electrical nerve
stimulation (TENS), and implanted cardiac devices.
•
Lead Movement – The patient should be instructed to avoid excessive bending, twisting,
and stretching, entering hyperbaric chambers above 2.0 atmosphere, and operating the
neurostimulator while driving or lifting objects of over 2 Kg (5 lbs) for a minimum of 6
weeks after implantation. These activities may cause lead movement, which can result
in understimulation or overstimulation for the patient. Excessive lead migration may
lead to the need for reoperation to replace the leads.
15
Spinal Modulation, Inc.
•
Physician Implant Manual
Therapeutic Radiation – Therapeutic radiation may damage the electronic circuitry of
an implanted neurostimulation system, although no testing has been performed and no
definite information on radiation effects is available. Sources of therapeutic radiation
include x‐rays, cobalt machines, and linear accelerators. If radiation therapy is required,
the area over the implanted INS should be shielded with lead.
Precautions
The following precautions apply to the use of the Axium™Neurostimulator System:
•
Physician Training – Implanting physicians should be experienced in the diagnosis and
treatment of chronic pain syndromes and have undergone surgical and device
implantation training.
•
Patient Selection – It is extremely important to select patients appropriately for
neurostimulation and that thorough psychiatric screening be performed. Patients
should not be dependent on drugs and should be able to operate the spinal cord
stimulator system.
•
Infection – It is important to follow proper infection control procedures. Infections
related to system implantation might require that the device be explanted.
•
Implantation of Two Systems – If two systems are implanted, ensure that at least 15 cm
(6 in) separates the implanted INSs to minimize the possibility of interference during
programming.
•
Implantation of Multiple Leads – If multiple leads are implanted, leads and extensions
should be routed in close proximity. Nonadjacent leads can possibly create a conduit for
stray electromagnetic energy that could cause the patient unwanted stimulation.
•
High Stimulation Outputs – Stimulation at high outputs may cause unpleasant
sensations or motor disturbances or may render the patient incapable of controlling the
patient programmer. If unpleasant sensations occur, the device should be turned off
immediately.
•
Stimulation Parameters – Patients should be cautioned that stimulation parameters
must be determined under the supervision of a physician and that they should not
adjust stimulation parameters within prescribed programs unless ordered to do so by a
physician.
•
Cellular Phones – The effect of cellular phones on neurostimulation systems is
unknown; patients should avoid placing cellular phones directly over the system.
•
Trial Leads – Trial Leads are intended for use for up to 30 days. Use of these devices
must be performed in accordance with the instructions provided in this manual.
•
Overprogramming – Excessive communication with the device can shorten the life of
the INS. The patient should be warned to communicate with the device only when
necessary.
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Spinal Modulation, Inc.
Physician Implant Manual
•
TNS Device Care – The patient must be instructed to not spill fluids on, to wash or
otherwise get their TNS device wet. The patient must not shower or bathe with it
(sponge baths are acceptable as long as the TNS device does not get wet). The patient
must be instructed not to drop or mishandle their TNS device. Physical damage to the
unit may impair its function. The patient must be instructed to not open the TNS case.
•
Lead and Cable Care – The patient must be instructed to not remove their lead(s) or
Connector Cable during the trial period. Manipulation of the components may result in
the patient developing an infection, getting undesirable stimulation, or accidentally
turning their stimulation off.
•
TNS Device Failure – Device failure, although unlikely, is possible due to random
component failure. If the TNS device stops working, the patient should contact their
physician.
•
TNS Device Disposal – The patient is to be instructed that they must return their TNS
device and Patient Programmer to their physician after the trial period. The patient
must be instructed to not discard or burn their TNS device. Fire may cause the internal
battery to explode.
•
TNS Battery Replacement – It is unlikely that the battery will need replacement in the
short time that the patient has their TNS device. However, if the TNS device does not
function the patient must not try to open the TNS case. The internal battery must be
replaced by Spinal Modulation personnel only. The patient should be advised to contact
their physician during regular business hours.
•
Material Sensitivity – Hypersensitivity (redness in the area of skin contact) can happen
if the patient has an allergic reaction to the materials. If this occurs, the patient should
be instructed to contact their physician during regulator business hours.
Adverse Events
The implantation of a neurostimulation system involves risk. In addition to those risks
commonly associated with surgery, the following risks are also associated with
implantation and use of the Axium™ Neurostimulator System:
•
•
•
•
•
•
•
•
•
•
•
•
•
Pain (where the needle has been inserted)
Pain (caused by understimulation due to lead migration)
Pain over the implantable neurostimulator site
Escalating pain
Bleeding (where the needle has been inserted)
Headache
Infection
Localized collection of serous (clear) fluid at injection site
Discomfort during the treatment
Allergic or rejection response to implant materials
Constant pain at the lead site
Stimulation of the chest wall
Lead migration (movement) and/or local skin breakage
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Weakness
Clumsiness
Numbness
Temporary muscle activation
Very rare risks and side effects include:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Cerebral Spinal Fluid (CSF) leakage
Tissue damage
Nerve damage
Spinal cord compression
Paralysis
Hematoma
Swelling
Seroma
Sensory loss
Skin erosion around the INS or leads
Battery failure and/or battery leakage
Lead breakage requiring replacement of the lead
Hardware malfunction requiring replacement of the neurostimulator
Pain from a non‐injurious stimulus to the skin (allodynia)
An exaggerated sense of pain (hyperesthesia)
Additional risks to the subjects, as a result of the placement and stimulation of the lead in the
area of the DRG, include potential tissue damage or pain due to 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
subjects will be awake and conversant during the procedure to minimize the likelihood of any
nerve damage.
Implanting the Neurostimulator System
Precautions for the Implant Procedure
•
All implanting physicians should be experienced in the diagnosis and treatment of
chronic pain syndromes and have undergone surgical and device implantation training.
•
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.
•
Do not insert the sheath into the epidural space without the lead inserted, as this may
cause injury to the dura. The lead cannot be inserted into the sheath with the sheath in
the epidural space.
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•
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.
•
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.
•
Do not use surgical instruments to handle the lead. The force of the instruments may
damage the lead or lead stylet.
•
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.
•
Do not over manipulate the sheath and lead system as this may result in trauma within
the epidural space.
•
Do not use saline or other ionic fluids at or near any of the electrical connections, as this
could result in short circuits.
•
Do not place sutures directly around the lead body since the sutures may damage the
lead.
•
Before opening any sterile package, verify the kit model number, that the kit is within its
expiration (use‐by) date and that the packaging has not been damaged or compromised
in any way. If the packaging has been compromised or the device is beyond its
expiration date, do not use the device as it may be compromised and could cause harm
to the patient.
•
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.
•
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.
•
The leads, accessories, and neurostimulator are only compatible with the Spinal
Modulation components. Use of other manufacturer’s components may result in
unexpected device performance and increased risk of injury to the patient.
Selection of Neurostimulator Trial Approach
There are two suggested approaches for a neurostimulation trial:
A. Percutaneous Lead Trial ‐ A trial is done using a Trial Lead which exits the skin at the needle
entry site and which is completely removed after the trial period. In a second procedure,
the system is implanted, including the Implant Leads.
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B. Implanted Lead + Percutaneous Extension Trial – A trial is done with an Implant Lead
sutured to the soft tissue just above the spinous process, using the soft tissue anchor to
protect the lead. An extension is tunneled away from the needle insertion site where it
exits the skin. In a second procedure only the Lead Extension is removed and the Lead or a
new Lead Extension is tunneled to a pocket, the INS is implanted in the pocket, and the
Lead or Lead Extension is connected to the INS.
Preparing the Patient and Devices for Use
Leads are designed for placement in the epidural space. Each Lead is accompanied by
accessories designed to aid the clinician in positioning the tip of the Lead near the target DRG.
•
To perform a Percutaneous Lead trial, use the temporary Trial Lead Kit.
•
To perform an Implant Lead trial, use the Implant Lead Kit.
CAUTION: The temporarily placed Trial Leads are intended for use for up to 30 days. Use of
these devices must be performed in accordance with the instructions provided in this
manual.
Using standard sterile technique, perform the appropriate skin prepping, draping, and injection
of local anesthetic to perform the epidural approaches for percutaneous lead placement.
WARNING: The placement of the leads involves some risk, as with any surgical
procedure. Conscious sedation can cause side effects such as systemic toxicity, or
cardiovascular or pulmonary problems. Use caution when sedating the patient. The
patient must be awake and conversant during portions of the procedure to minimize the
likelihood of nerve damage.
Placing the Lead
Lead placement should always be done under fluoroscopic guidance. The appropriate vertebral
level for needle entry should be identified and marked.
WARNING: As with any spinal epidural procedure, potential risks of serious injury to the
patient, although extremely rare, include epidural hemorrhage, hematoma, infection,
spinal cord or nerve compression, and/or paralysis.
1. Determine the length of the lead required to extend from the target foraminal level to the
Neurostimulator implantation site. Using a 90 cm lead in the lumbar region may cause
difficulty in coiling the excess lead. A 50 cm lead used in the upper thoracic region may not
be long enough to reach the Neurostimulator and a lead extension may be needed to bridge
the additional length.
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Choosing an Approach
2. Antegrade Approach
Under fluoroscopic guidance, use a contralateral approach, with the bevel of the needle
facing toward the target level, to insert the Delivery Needle into the epidural space at the
appropriate angle until you encounter resistance from the ligamentum flavum. Start one or
two levels below the target site. The needle angle should be no greater than 30 degrees to
ensure smooth delivery of the delivery sheath and lead.
Single Level Delivery Approach
Two Level Delivery Approach
3. Contralateral Approach
Under fluoroscopic guidance, use a contralateral approach with the bevel of the needle
facing toward the target level to insert the 14G delivery needle into the epidural space.
WARNING: When using a contralateral approach, advance the needle slowly into the
epidural space and take caution as it enters. The needle will be inserted at a steeper
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angle than in an antegrade approach and there is a greater chance of dural puncture that
will lead to a cerebrospinal fluid leak.
4. Confirm entry into the epidural space using standard methods, such as a loss of resistance
technique.
5. Once loss of resistance is achieved, the clinician may verify complete insertion into the
epidural space using fluoroscopic guidance and/or inserting the guidewire through the
needle. If resistance is discovered during guidewire insertion, either pull the needle out and
repeat Steps 1‐4 using a more acute angle or advance the needle further and reconfirm
placement using the guidewire.
WARNING:
Use fluoroscopy and extreme care when inserting, advancing, or
manipulating the guidewire or lead in the epidural space to minimize the risk of a dural
tear.
WARNING: Dural puncture can occur if needle or guidewire is advanced aggressively once
loss of resistance is achieved. Advance the needle and/or guidewire slowly.
6. Remove the guidewire (if used) after confirmation of access to the epidural space.
NOTE: The Complex Curved Stylet has been pre‐inserted into the lead and the lead has been
loaded into a 22 cm Small Curve Sheath to facilitate delivery by the clinician.
7. Before insertion into the needle, push the lead outside the sheath and verify that the stylet
is pushed fully distal within the lead.
NOTE: Failure to ensure the stylet is completely inserted may make delivery of the lead
more difficult.
8. Before insertion into the needle, pull back on the lead so that the ball‐tip end of the lead is
flush against the Delivery Sheath and tighten down the lead stabilizer until the lead does
not slide within the sheath.
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Tightening the Lead Stabilizer
WARNING: Insertion of a sheath without the lead may result in dural puncture. Securing
the lead with the lead stabilizer will mitigate this risk.
WARNING: Use of the delivery sheath is necessary for successful placement of the Lead.
9. Note that the steering wing on the sheath lines up with the bend in the sheath.
10. Before inserting the sheath into the needle, verify that the Lead is loaded. The Lead cannot
be delivered through the sheath once the sheath is located within the epidural space.
11. Insert the sheath, lead, and stylet through the needle and advance through the epidural
space to the target foraminal opening.
WARNING: If the sheath needs to be retracted from the epidural space, verify that the
steering wing is no more than 90 degrees misaligned with the mark on the needle. Failure
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to do so may result in damage to the sheath. Before reinserting sheath, verify there is no
damage to the sheath.
WARNING: If the sheath is not responding to rotation, do not rotate the steering wing
out of plane from the curve of the sheath more than 90 degrees. The tip of the sheath
may whip around and could cause harm to the patient.
12. With the distal end of the sheath in or at the target foramen, loosen the lead stabilizer,
and advance the lead so that it moves into the foramen. Confirm placement of the lead on
the dorsal side of the foramen using a lateral fluoroscopic view. Verify that the electrodes
extend out of the sheath. If the electrodes remain within the sheath, stimulation will not
be possible because of high impedance readings.
Loosening the Lead Stabilizer
WARNING: If the lead is unable to deploy out of the sheath, inject sterile water or saline
slowly to release tissue that may have entered between the sheath and the lead. Do not
use excessive pressure when injecting through the sheath.
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Lead Advanced Along Dorsal Aspect of DRG
WARNING: Do not use excessive force to push the lead or sheath into the neural
foramen as this may result in permanent or transient nerve damage. The patient should
be awake and conversant during this part of the procedure so they can provide feedback
to the physician.
Intraoperative Testing
1. Connect the head to the cable. Press and hold the cable button down to release the
locking mechanism and slide the proximal end of the leads into the head. Release the
cable button to lock the lead into place. Verify that the lead comes to a stop before
releasing the button. This will ensure that the electrical contacts are in the appropriate
position.
Head
2. Put the TNS in standby mode or turn the amplitude of each lead set to zero.
PRECAUTION: Put the trial stimulator in standby mode or reduce amplitude of leads to
zero before plugging in the cable. Failure to do so may result in delivering an
uncomfortable stimulation to the patient.
3. Pass the proximal end of the Connector Cable off the sterile field and connect to the TNS.
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NOTE: Refer to the Trial Neurostimulator User Manual and Clinical Programmer User
Manual for specific instructions on the operation of these devices.
WARNING: Maintain adequate slack in the cable. If there is not enough slack and the
cable is pulled, the lead may be dislodged and will need to be replaced. This will extend
the procedure.
4. Using the TNS, test the various electrode configurations used to obtain appropriate
paresthesia or pain relief.
5. Turn off the Trial Neurostimulator and disconnect the lead from the connector cable.
6. Up to four leads may be placed in one patient. Refer to “Placing the Lead” to position
subsequent leads.
WARNING: As described in the Clinical Programmer User Manual, always turn the
external TNS amplitude to 0 µA when repositioning a lead, changing the selected
electrode combination, or attaching the Connector Cable to the external TNS. When
restarting stimulation, increase the amplitude SLOWLY until the desired paresthesia is
achieved. Failure to do so may result in uncomfortable motor activation or painful
stimulation.
Removing the Delivery System Components – Percutaneous Lead Trial
1. Before removing the delivery system components, advance the lead further into the
epidural space to create a strain relief.
2. Slowly remove the delivery sheath by first pulling back the sheath near the needle. Always
hold forward pressure on the Lead while retracting the delivery sheath to prevent lead
migration.
3. Retract the stylet into the needle so that it is retracted beyond the tip of the sheath.
4. Turn the sheath away from the opening of the foramen and push out the lead so that a
loop is created in the epidural space.
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WARNING: Failure to put a loop in the epidural space may result in lead migration and
may lead to a procedure to revise the position.
5. Remove the sheath completely while holding forward pressure on the lead.
WARNING: When removing the sheath, verify that the steering wing is no more than 90
degrees misaligned with the mark on the needle. Failure to do so may result in damage
to the sheath. Before reinserting sheath, verify there is no damage to the bend of the
sheath.
6. Remove the needle following the same procedure. It is recommended that the desired
paresthesia be re‐tested after the removal of the delivery system components but before
the complete removal of the stylet. With the external TNS amplitude set to 0 µA,
reconnect the Connector Cable as described before.
WARNING: If the sheath has been kinked during delivery, slowly retract through the
needle with the curve facing the same direction as the bevel. Failure to do so can
damage or cut the lead or sheath. If resistance is encountered, pull the needle out of the
epidural space and then remove the sheath.
WARNING: Do not use excessive force if the lead needs to be removed. Excessive force
may cause lead fracture.
7. Record the lead position with both an A/P and lateral fluoroscopic view for comparison of
the position at time of closure to ensure that the lead has not moved. Remove the stylet
by holding forward pressure on the lead while retracting the stylet.
WARNING: Use extreme care when removing the lead stylet, the delivery sheath, and
the needle, to insure that the distal tip of the lead remains in the desired location.
Removing each item in slow movements, while holding the remaining components in
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place, will assist this process.
Lead Anchoring – Percutaneous Lead Trial
1. After placing a Trial lead in its final position, it should be secured using a lead anchor on
the skin.
2. Carefully slide the lead anchor over the proximal end of the Trial Lead and advance it to
the puncture site. The short end of the suture anchor must be facing towards the incision.
3. Apply sutures around the anchor and cinch onto the Trial Lead as shown below. Apply at
least two ties to the main body and one tie to the leg.
WARNING: Do not suture directly onto the lead, as there is a risk of damaging the lead.
Failure to secure the lead to the skin, or other tissue, may result in lead migration and/or
motor activation or painful stimulation.
WARNING: Failure to comply to the anchoring technique may result in lead migration
and/or motor activation or painful stimulation.
4. Apply an antibacterial agent to the puncture site, if desired
5. Reconnect the connector cable to the leads and coil any excess Trial Lead length around
the distal end of the Connector Cable, fold a gauze pad around the block, and apply a large
adhesive patch over the area containing the Trial Lead(s), puncture site and Connector
Cable.
6. Verify the connection of the Connector Cable to the Trial Leads and the external TNS prior
to discharge of the patient.
Neurostimulation Trial –Percutaneous Lead Trial
1. Using the Clinical Programmer, program the TNS with the neurostimulation trial
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parameters.
NOTE: Refer to the Trial Neurostimulator User Manual and Clinical Programmer User Manual
for specific instructions on the programming of these devices.
Removing Trial Lead –Percutaneous Lead Trial
WARNING: Always remove the Trial Leads before implanting the Implant Leads, as there
is a risk of infection that may cause death if the leads are not removed. Always practice
proper sterile practices when implanting leads and implantable neurostimulator.
To remove the Trial Lead(s) from a patient:
1. Disconnect the Connector Cable connection for each Trial Lead.
2. Remove any sutures or anchor securing each Trial Lead to the patient’s skin.
3. Slowly apply light tension to each Trial Lead and verify that the lead is retracting from the
patient.
4. Place the used Trial Lead(s) into a designated “Biohazard” package clearly labeled with the
patient’s ID number and the removal date.
5. Send Trial Lead(s) back to Spinal Modulation for evaluation as instructed by clinical
personnel.
WARNING: Do not remove a Trial Lead quickly, as this may result in lead breakage and
unintentional lead fragments being left in the patient.
WARNING: Take proper precautions when handling removed Trial Lead components.
Treat all used Trial Leads and delivery components as a “biohazard”.
WARNING: Do not reuse any device from the Trial Lead Kit or Trial Accessories Kit.
Removing the Delivery System Components – Implant Lead Trial Only
These instructions pertain only after placing Implant Lead during the trial procedure. After
placing a lead in its final position, using the techniques described above, it should be secured
using a lead anchor to the supraspinous ligament or fascia and then connected to the
externalized lead extensions.
WARNING: Do not suture directly onto the lead, as there is a risk of damaging the lead.
Failure to secure the lead may result in lead migration and uncomfortable motor
stimulation or painful stimulation.
PRECAUTION: Use extreme care when using sharp instruments or electrocautery around
the lead to avoid damaging the lead.
1. Leaving the needle in place, prepare the anchor site by making an approximately a 3 ‐ 7 cm
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longitudinal incision, centered on the needle to the depth of the supraspinous ligament.
2. Establish hemostasis and use retractors for good visualization.
3. Slowly remove the delivery sheath by first pulling back the sheath near the needle. Always
hold forward pressure on the Lead while retracting the delivery sheath to prevent
movement.
4. Retract the stylet into the needle so that it is retracted beyond the tip of the sheath.
5. Turn the sheath away from the opening of the foramen and push out the lead so that a
loop is created in the epidural space.
WARNING: Failure to put a loop in the epidural space may result in lead migration and
may lead to a procedure to revise the position.
6. Remove the sheath completely while holding forward pressure on the lead.
WARNING: When removing the sheath, verify that the steering wing is no more than 90
degrees misaligned with the mark on the needle. Failure to do so may result in damage
to the sheath.
WARNING: If the sheath has been kinked during delivery, slowly retract through the
needle with the curve facing the same direction as the bevel. If resistance is
encountered, pull out the needle and then proceed to remove the sheath. Failure to do
so can damage or cut the lead or sheath.
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7. Remove the needle following the same procedure.
8. It is recommended that the desired paresthesia be re‐tested after the removal of the
delivery system components but before the complete removal of the stylet. With the
external TNS amplitude set to 0 µA, reconnect the Connector Cable as described before.
WARNING: Do not use excessive force if the lead needs to be removed. Excessive force
may cause lead fracture.
9. Record the lead position with both an A/P and lateral fluoroscopic view for comparison of
the position at time of closure to ensure that the lead has not moved. Remove the stylet
by holding forward pressure on the lead while retracting the stylet.
WARNING: Use extreme care when removing the lead stylet, the delivery sheath, and
the needle, to ensure that the distal tip of the lead remains in the desired location.
Removing each item in slow movements, while holding the remaining components in
place, will assist this process.
Lead Anchoring
After placing a lead in its final position, it should be secured using a soft tissue anchor and then
connected to externalized extensions.
WARNING: Do not suture directly onto the lead, as there is a risk of damaging the lead.
Failure to secure the lead to the skin, or other tissue, may result in lead migration and
uncomfortable muscle stimulation.
PRECAUTION: Use extreme care when using sharp instruments or electrocautery around
the lead to avoid damaging the lead.
1. Soak the anchor in sterile water (not saline) to lubricate it.
2. Place the anchor on the lead and slide it down as close as possible to where the lead
emerges from the vertebral column. Be careful not to move the lead.
NOTE: If implanting multiple leads, tag the leads with suture (ligature) so that their position
can be identified later.
PRECAUTION: Observe these cautions when attaching the soft tissue anchor because
damage to the anchor or lead can occur and result in failure of the system:
•
Do not use polypropylene or monofilament suture
•
Do not place sutures directly on the lead.
•
Avoid sharp bends or kinking on the lead.
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3. Using the 2‐0 silk non‐absorbable suture, tie two ligatures around the center of the anchor
to secure the anchor to the lead. If needed, make minor adjustments to the lead position.
Tie one ligature around the leg and do not tie to the soft tissue. Verify that the short end
of the anchor enters into the ligament.
PRECAUTION: Failure to push the short end of the soft tissue anchor into the ligament or
fascia may result in lead migration and a procedure to revise the lead location.
4. It is recommended that the lead position is verified under fluoroscopy and desired
paresthesia be re‐tested after fixation. With the external TNS amplitude set to 0 µA,
reconnect the Connector Cable as described before.
Percutaneous Extension Tunneling – Implant Lead Trial Only
1. Identify the tunneling route between the lead incision and the extension exit site.
2. Administer anesthetic at the exit site and along the tunneling route.
3. Assemble the tunneling tool packaged with the lead by slipping the passing straw over the
tunneling rod, then attaching the tunneling tip.
4. Bend the tunneling tool as necessary to conform to the patient’s contour along the
tunneling route.
5. Make a stab wound at the exit site.
6. Begin at the exit site and tunnel subcutaneously to the lead incision
7. Guide the tunneling tool subcutaneously along the tunneling route by pushing the skin
over the advancing tool tip until the tip and approximately 1 cm of the passing straw are
exposed at the lead incision.
8. Withdraw the tunneling tool leaving the passing straw in place in the tunnel.
9. Gently insert the proximal end of the extension through the passing straw to the exit site.
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10. Slide the passing straw over the extension and out of the skin exit site, leaving the
extension in place.
11. If not done previously, use blunt dissection to a form a subcutaneous pocket off the lead
incision for the lead‐extension connection.
12. Wipe the lead and extension connector junction with sterile gauze. If necessary, moisten
the gauze with sterile water or a nonionic antibiotic solution.
13. Dry all connections. Fluid in the connection may result in stimulation at the connection
site, intermittent stimulation, or loss of stimulation.
14. Hold the extension connector straight while firmly, but gently, inserting the lead into the
connector one or two contacts at a time until each lead contact is aligned under each
extension connector contact. During insertion, some resistance is typical because the
internal seals provide electrical isolation.
15. Verify that the mark on the lead aligns with the end of the extension connector. This will
verify that the lead is fully inserted.
16. Use the torque wrench supplied in the package to tighten the setscrew. Tighten until a
click is heard. Using minimal force, and while securely holding the lead to prevent
dislodgement, pull on the connection to ensure that it is secure.
17. Using minimal force, pull the extension from the skin exit site, feeding the lead‐extension
connection into the lead‐extension connection pocket.
18. In order to aid in identification of each lead after the trial period, tie a suture lightly to the
lead and another one to the lead extension. Use different color suture and numbers of
suture to identify the leads. This will aid in identification during the implant procedure.
19. Create strain relief loops by coiling excess lead proximal to the soft tissue anchor in loops.
Insert the coiled lead into the pocket, under the connection, leaving as much slack as
possible in the lead between the anchor and the lead‐extension connection.
20. Close the incision and dress the incision site.
21. At the exit site, coil any excess extension around the distal end of the Connector Cable,
fold a gauze pad around the block, and apply a large adhesive patch over the area
containing exit puncture, excess extension, and Connector Cable.
Removing Lead Extension – Implant Lead Trial Only
1. Remove the bandage near the exit point of the lead extension.
2. Pull the lead extension lightly out of the incision and cut the lead extension.
3. Expose the lead‐extension to lead connection.
4. While maintaining lead position, carefully remove the lead‐extension connections from the
incision.
5. Disconnect the lead from the extension.
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6. Cut the extension near the lead‐extension connector.
7. Discard the lead‐extension connector.
8. Preserving sterility, pull the extension out through the skin exit site.
9. Discard the extension.
10. If multiple extensions are implanted, repeat the removal steps for the other extensions.
Creating the INS Pocket – Implant
Once the lead(s) has been anchored, a Neurostimulator pocket should be created and the lead
tunneled for connection to the INS.
The following steps outline the suggested procedure to create an INS pocket:
1. Determine the site for the INS. This should be done before implanting the lead to verify
there is enough length to reach the INS pocket and provide strain relief in the pocket, near
the anchor, and in the epidural space.
NOTE: The INS should be located in an area that the patient can easily reach with the
magnet and/or programmer:
•
In the upper buttocks along the posterior axillary line (avoiding the beltline)
•
Just over the abdomen below the lowest rib
2. Administer local anesthetic at the neurostimulator pocket site.
3. Use blunt dissection to create a pocket so that the INS is parallel to the skin surface and no
deeper than 2.0 cm below the skin surface. Use electrocautery to maintain hemostasis.
4. (Optional) Insert the INS sizer to ensure the pocket is large enough to accommodate the
INS, allowing extra room for a strain relief loop for each lead.
PRECAUTION: Do not implant the INS deeper than 2.0 cm, as the programmer will not be
able to communicate with the INS.
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PRECAUTION: Do not apply electrocautery directly to the INS as this can damage the INS
or cause interference while communicating with the INS.
Lead or Extension Tunneling
Tunnel the leads from the anchor site to the INS pocket. When tunneling to the abdomen, the
clinician has two options:
•
Tunnel to a midpoint and then continue to INS site.
•
Use the 51 cm tunneling tool and curve the conduit around the side of the patient.
The following steps outline the suggested procedure to tunnel from the lead anchor site to the
INS pocket:
PRECAUTION: Use extreme care to not damage the lead with the sharp point of the
tunneling tool.
1. Identify the tunneling route between the lead incision and the neurostimulator pocket.
2. Administer local anesthetic along the tunneling route. Additional sedation may be
administered at the discretion of the physician.
3. Bend the tunneling tool as necessary to conform to the patient’s contour along the
tunneling route
4. With the straw in place on the tunneling tool, tunnel from the INS pocket to the lead
anchor site.
5. Withdraw the tunneling tool from the straw, leaving the straw in the subcutaneous
tunnel.
PRECAUTION: Leads or Extensions should be routed adjacent to one another as to prevent
changes in perceived stimulation from theft detectors and metal screening detectors.
6. Pass the end of the Lead(s) or Extension(s) through the straw from the anchor site to the
INS pocket or to the midpoint if tunneling to the abdomen. At each incision point, leave
a strain relief loop in place as to minimize the chances of lead migration.
7. Remove the straw from the tunnel by passing it over the leads, taking care not to cause
traction on them and disturb the lead position.
Connecting Lead to Extension
If an extension is used to connect the Lead to the INS, refer to the section “Percutaneous
Extension Tunneling” for instructions on how to connect the Extension to the Lead.
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Connecting the INS
The following steps outline the guidelines to connecting a Lead or Extension to the INS:
PRECAUTION: Do not connect a lead with body fluid on its contacts because corrosion can
occur and cause failure of the system.
PRECAUTION: If there is a need to communicate with the INS prior to implantation, do not
put the INS on a stainless steel table, as communication may be difficult. This may prolong
the procedure.
1. If the lead contacts came in contact with body fluids or saline, thoroughly clean with
sterile deionized water or sterile water for irrigation and then dry them completely.
2. Using clean gloves, carefully slide the lead or extension into the INS header until the
depth marker aligns with the edge of the header.
PRECAUTION: Use only the torque wrench provided by Spinal Modulation or the device or
lead may be damaged and unusable. Tighten until a click is heard or the lead may make
intermittent contact with the stimulator.
3. Insert the torque wrench through the seal plug and tighten the setscrew by turning it
clockwise, until the wrench clicks.
4. Carefully remove the torque wrench and verify that the septum over the set screw is
closed. Reseat the flaps if it is not closed.
5. If implanting less than 4 leads, insert the port plugs in each of the vacant header ports.
Use the torque wrench to tighten the setscrew on the port plug until it clicks.
PRECAUTION: Insert the lead slowly into the header to prevent damage to the INS. If the
lead needs to be retracted, retract the lead slowly.
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Implanting the INS
The following steps outline the procedure for implanting the INS:
PRECAUTION: Do not implant the INS face down. Always implant with the label facing up.
Failure to do so will prevent communication with the programmer and/or magnet.
PRECAUTION: If using more than INS, implant them at least 15 cm apart. Putting them too
close together may interfere with the programmer’s ability to communicate with each one
separately.
1. Place the INS into the pocket at a depth no greater than 2 cm from the skin surface, with
the label facing the skin surface.
2. Carefully coil excess lead behind the INS or around the INS in loops to provide strain
relief for the lead and INS connection.
PRECAUTION: Coiling the lead on the top surface of the INS (closest to the skin) will
interfere with the ability of the programmer to communicate with the device.
PRECAUTION: Do not bring the suture needle in contact with the INS, or lead during
sewing the INS into the pocket or closing the pocket. The components may be damage if
this occurs.
3. To stabilize the INS within the pocket, pass a suture through the two suture holes in the
INS and secure it to connective tissue.
4. Check the entire system by fluoroscopy prior to closing to ensure proper positioning of
the leads. Verify that the leads have no sharp bends or kinks.
5. Place the magnet into a sterile bag and wave over the INS.
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6. Slowly awaken the patient and test for stimulation perception and thereby verifying the
system is operational.
NOTE: The INS output may not be identical to the trial neurostimulator output. Always start
stimulating from a setting lower than that used to stimulate with the trial neurostimulator.
7. Ensure that that the INS is away from the pocket incision suture line, close the pocket
incision, and apply appropriate dressings.
8. Fill out the patient registration information form and return it to Spinal Modulation.
Checking System Integrity
1. Place the magnet in a sterile pouch and wave it over the device to
start programmer communication.
2. Using the clinical programmer in the non‐sterile field, program
the basic stimulation parameters, check the battery status, and
check the electrode impedances to ensure there is no short or
open circuit.
3. Once the system’s function is verified, turn the neurostimulator off.
Completing the Procedure
1. Follow standard procedure for wound closure and bandaging.
Replacing an INS
The following steps outline the suggested procedure to replace an INS:
1. Turn off the INS and verify that it has been turned off.
Magnet Activation Target
Magnet must be within 3.5
cm of INS surface for
activation of
communication.
PRECAUTION: Exercise care when using sharp instruments or electrocautery around leads
or they might be damaged.
2. Open the INS implant site per normal surgical procedures.
3. Remove the suture from the INS header, without damaging the lead, and carefully
remove the INS from the pocket.
4. Clean the INS header and the lead with sterile water and then wipe with a surgical
sponge.
5. Insert the torque wrench through the septum of the INS header and loosen the setscrew
by turning it counterclockwise.
PRECAUTION: When performing the following steps, do not bend the lead sharply as this
may cause lead breakage.
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6. Gently remove the lead from the INS header; then clean and dry all connections on the
lead, ensuring they are free from fluid and tissue.
PRECAUTION: If resistance is met while removing leads from the epidural space, do not
use excessive force to extract. Always perform removal with the patient conscious and
able to give feedback.
WARNING: Do not remove a lead quickly, as this may result in lead breakage and
unintentional lead fragments being left in the patient.
WARNING: Take proper precautions when handling removed lead components. Treat all
used leads and delivery components as a “biohazard”.
7. If you need to replace a lead, perform the following actions:
a. Make an incision above the location of the suture anchor.
b. Carefully cut the sutures from the suture anchor.
c. Slide the lead out of the epidural space slowly.
8. To complete the INS replacement procedure, see “Connecting the Lead to the INS”.
9. To complete lead placement, see “Placing a Lead”.
Disposing of an Explanted Device
All explanted INSs should be returned to Spinal Modulation for proper disposal. To dispose of
an explanted device, follow these steps:
WARNING: Do not crush, puncture, or burn the INS because it may explode or catch on
fire.
1. Decontaminate the explanted device.
2. Place it in a container with a biohazard label.
3. Include a completed “Returned Product Form.” (One is packaged with each new INS)
4. Return the explanted device to:
Spinal Modulation
1135 O’Brien Drive
Menlo Park, CA 94025
U.S.A.
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Appendix A: Trial Lead Kit / Implant Lead Kit
How Supplied
The components of the Spinal Modulation Trial Lead Kit and Implant Lead Kit are provided
sterile in a double pouch assembly and are intended for single use only. Do not resterilize or
reuse any devices from the Lead Kits, for any reason, because of risk of infection to the subject
and malfunction of the devices.
PRECAUTION: Do not resterilize the Lead Kits or any other sterile components as it will
create a risk of infection or malfunction of the device.
Storage Temperature ‐ Store the Trial Lead Kit and Lead Accessories Kit between 14°F (‐10°C)
and 122°F (50°C). Temperatures outside this range may damage the components. If a
temperature deviation has occurred, do not use the product.
Sterilization ‐ The Trial Lead Kit, Connector Cable, and all Lead Kit Accessories have been
sterilized using ethylene oxide (EO) gas.
Package Contents
(1) Trial / Implant Lead 50 cm / 90 cm
(1) 22 cm Small Curve Delivery Sheath
(1) 22 cm Big Curve Delivery Sheath
(1) Guidewire
(1) Complex Curve Stylet
(1) 4.5” 14 Gauge Needle
(2) Soft Tissue Anchors
(1) Physician Implant Manual
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Device Specification
The Lead has four electrodes on the distal end and the proximal end fits into a four conductor
connector on the Connector Cable or into the INS ports. The Complex Curved Stylet has been
inserted into the proximal end of the lead and the lead has been pre‐loaded into a 22 cm Small
Curve Delivery Sheath for user convenience. An illustration of the Trial Lead is given in Figure 1.
Figure 1: Lead showing four proximal electrical connectors and four radiopaque electrodes
The approximate measurements for a Trial Lead are presented below:
Proximal Electrical Connector..................Quadrapolar, in‐line
Center to Center Connector Spacing ........3.3 mm (0.130”)
Diameter ..................................................1.0 mm (0.040”)
Length ......................................................50 cm (20”) or 90 cm (35”)
Number of Electrodes……………………........4
Electrode Shape…………………………….........Cylindrical
Electrode Length ......................................1.25 mm (0.050”)
Edge to Edge Spacing ...............................5 mm (0.200”)
Center to Center Spacing.........................6.25 mm (0.250”)
Array Length………………………………….........20 mm (0.790”)
Ball Tip Diameter......................................1.5 mm (0.060”)
Stylet Wire Diameter………………...............0.25 mm (0.010”)
DC Lead Impedance (50cm / 90cm / Extension)…. <20Ω / <35Ω / <60 Ω
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Appendix B: Trial Neurostimulator
Device Description
See the Trial Neurostimulator Manual for the full description of the device. The external Trial
Neurostimulator (TNS) provides energy and controls electrical signals delivered to the Leads.
The TNS device is intended to be connected to the Leads and worn by the subject for up to 30
days during the study period. The device is intended to be connected to the Spinal Modulation
Connector Cable. It is not compatible with other cables from other manufacturers. The
external TNS device has a belt clip that can be used or the subject may choose to use a flexible,
elastic bandage to secure their TNS device during the trial period. The patient should be
advised not to allow the TNS to make direct contact with skin.
Package Contents
(1) Trial Neurostimulator
(1) TNS Manual
Device Specifications
Specifications
Range
Step Size
Default Value
Pulse Amplitude ‐ PA (µA)
(Depending on measured impedance)
0 – 6000 µA
25 µA: 0‐2000 µA
50 µA: 2000‐6000 µA
0 µA
Maximum Pulse Amplitude ‐ Max (µA)
Programmable by Patient
Same as PA
Same as PA
0 µA
Pulse Width – PW (µs)
40 – 720 µs
10 µs
40 µs
Pulse Frequency ‐ PF (Hz)
4 – 100 Hz
2 Hz
60 Hz
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Handling
Storage Conditions: ‐10°C ‐ 50°C
Humidity Range: 10 – 93%
Cleaning Instructions for Healthcare Professional: For disinfecting the TNS surfaces after gross
filth and heavy soil loads have been removed, spray Cavicide or equivalent onto a paper towel,
and then wipe the surface of the TNS with the wet paper towel. Allow the surface to remain
damp for 2 minutes. Dry the surface using a dry paper towel. Do not immerse the TNS in
liquid. Advise the patient not to clean the TNS with excessive liquid. A damp cloth may be used
to wipe the TNS, if necessary.
WARNING: Always wear the TNS on the outside of clothing as the material may cause
skin irritation.
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Appendix C: Implantable Neurostimulator
How Supplied
The Axium™ Implantable Neurostimulator is provided sterile in a double tray assembly and is
intended for single use only. Do not resterilize or reuse, for any reason, because of risk of
infection to the patient and malfunction of the devices.
PRECAUTION: Do not resterilize the INS as it will create a risk of infection or malfunction
of the device.
Device Description
The Implantable Neurostimulator is a four channel neurostimulator that is only compatible with
Spinal Modulation Implant Leads and Lead Extensions. It has four ports to allow for stimulation
of up to four leads simultaneously. It has an antenna in the header that allows wireless
communication with the device using the Spinal Modulation Clinical Programmer or Patient
Programmer.
Package Contents
(1) Implantable Neurostimulator
(3) Lead Port Plugs
(1) Torque Wrench
(1) Sterile Magnet Sleeve
(1) Medical Alert Card
(1) Reference to Implant Manual
Device Specifications
Output of the INS is equivalent to the output of the TNS. The device is programmed in current,
impedance is measured by the device, and the appropriate output voltage matches the
impedance and current programmed.
Specifications
Range
Step Size
Default Value
Pulse Amplitude ‐ PA (µA)
0 – 6000 µA
25 µA: 0‐2000 µA
50 µA: 2000‐6000 µA
0 µA
Maximum Pulse Amplitude ‐ Max (µA)
Programmable by Patient
Same as PA
Same as PA
0 µA
Pulse Width – PW (µs)
40 – 720 µs
10 µs
40 µs
Pulse Frequency ‐ PF (Hz)
4 – 100 Hz
2 Hz
60 Hz
(Depending on measured impedance)
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Therapy Accuracy.....................................10% over the range of 300 to 6000 µA
Impedance Measurement Accuracy ........5% over the range of 400 to 2000 Ohms
Height.......................................................6.52 cm (2.57 in)
Width .......................................................4.77 cm (1.88 in)
Thickness..................................................1.10 cm (0.43 in)
Volume .....................................................31 cm3 (1.89 in3)
Maximum Connector Strength ................10N
Number of Channels ................................4
Power Source ...........................................CFx, lithium ‐ carbon monofluoride
Storage Temperature...............................‐10°C (14°F) to 50°C (122°F)
Storage Humidity .....................................10% to 90%
Handling
Storage Conditions: ‐10°C ‐ 50°C
Humidity Range: 10 – 90%
Handling: Before implantation, only wipe with sterile water and do not use any cleaning
agents.
PRECAUTION: Before implantation, do not use chemicals or any cleaning agents to wipe
the INS. This may cause irritation or inflammation at the implant site.
Device Longevity
For information regarding device longevity, contact Spinal Modulation.
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The Axium™ Neurostimulator System complies with the following International Standards:
•
IEC 60601‐1: 2005
•
ISO 14708‐1: 2000
•
IEC 60601‐1‐11: 2010
•
ISO 14708‐3: 2008
•
IEC 60601‐1‐2: 2007
Company and Authorized Representative Contact Information
Spinal Modulation, Inc.
Healthlink Europe B.V.
1135 O’Brien Drive
Menlo Park, CA 94025
U.S.A.
Telephone: (650) 543‐6800 (24‐hour support line)
Fax: (650) 327‐2336
Email: clinicalsupport@spinalmodulation.com
De Tweeling 20‐22
‘s Hertogenbosch 5215 MC
The Netherlands
Telephone: + 31 13 547 9300
Fax: + 31 13 547 9301
Authorization to affix the CE mark granted in 2011
46

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