St. Jude Medical 3046, 3086 Clinician Manual
St. Jude Medical 3046 is a percutaneous trial lead kit used with St. Jude Medical trial systems for spinal cord stimulation (SCS) during a trial period of up to 30 days. It helps manage chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and intractable low back and leg pain.
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Percutaneous Trial Lead Kit
Models 3046, 3086
Clinician's Manual
Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude
Medical, Inc. and its related companies.
Pat. http://patents.sjm.com
© 2017 St. Jude Medical, Inc. All Rights Reserved.
Contents
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Prescription and Safety Information
Read this section to gather important prescription and safety information.
Intended Use
The percutaneous leads covered in this manual are intended to be used with St. Jude Medical™ trial systems for SCS during a trial period that shall not exceed 30 days.
Indications for Use
St. Jude Medical™ neurostimulation systems are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
Contraindications
This system is contraindicated for patients who are unable to operate the system.
Warnings
The following warnings apply to these components.
Poor surgical risks.
Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.
Magnetic resonance imaging (MRI).
Patients with implanted neurostimulation systems should not be subjected to MRI. MRI can cause a temperature rise in the electrodes leading to serious injury.
Additionally, the electromagnetic field generated by an MRI may dislodge implanted components, damage the device electronics, and induce voltage through the lead that could jolt or shock the patient.
Diathermy therapy.
Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.
Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment.
Electrosurgery devices.
Electrosurgery devices should not be used in close proximity to an implanted IPG or lead. Contact between an active electrode and an implanted IPG or lead can cause severe injury to the patient.
Implanted cardiac systems.
Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately.
To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.
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Theft detectors and metal screening devices.
Certain types of antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public establishments, and airport security screening devices may affect stimulation. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which has been described by some patients as uncomfortable or jolting. Patients should use caution when approaching such a device and should request assistance to bypass the device. If they must proceed through the device, patients should turn off the IPG and proceed with caution, being sure to move through the detector quickly.
Device components.
The use of components that are not approved by St. Jude Medical with this system may result in damage to the system and increased risk to the patient.
Device modification.
To avoid damaging internal components or injuring a patient, do not modify the lead in any way, such as by cutting it or altering its shape.
Precautions
The following precautions apply to these components.
General Precautions
Physician training.
Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and should have undergone sufficient surgical and device implantation training.
Infection.
It is important to follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.
Implantation of multiple leads.
If multiple leads are implanted, the leads should be routed to the
IPG in adjacent tunnels. Nonadjacent leads have the possibility of creating a conduit for stray electromagnetic energy that could cause unwanted stimulation in the patient.
Sterilization and Storage
Single-use device.
The implanted components of this neurostimulation system are intended for a single use only. The components of this kit have been sterilized using ethylene oxide (EtO) gas and are supplied in packaging permitting direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason because of risk of infection and device malfunction.
Exposure to liquids.
System components should be stored where they will not be exposed to liquids or excessive moisture, which can damage the seal integrity of the package materials.
Handling and Implementation
Expiration date.
An expiration date (or "use before" date) is printed on the packaging. Do not use a component if the use-before date has expired.
Care and handling of components.
Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, or the use of sharp instruments may damage and cause failure of the components.
Package and component damage.
Do not implant a device if the sterile package or components show signs of damage, the sterile seal is ruptured, or if contamination is suspected for any reason.
Return it to St. Jude Medical for evaluation.
Exposure to body fluids or saline.
Exposure of the internal metal (i.e., contacts on the lead, the
IPG, or extension) to body fluids or saline can cause corrosion and affect stimulation. If this occurs, clean with sterile deionized water or sterile water for irrigation and dry completely prior to lead connection and implantation.
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System testing.
The operation of the system should always be tested after implantation and before the patient leaves the surgery suite to ensure correct operation.
Component disposal.
Return all explanted components to St. Jude Medical for safe disposal.
Home and Occupational Environments
Lead movement.
Patients should be instructed to avoid bending, twisting, stretching, or lifting objects over five pounds during the trial period. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in ineffective or overstimulation.
Adverse Effects
The use of a neurostimulation system involves risk. In addition to those risks commonly associated with surgery, the following risks are also associated with use of a neurostimulation system:
Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure
Stimulation in unwanted places (such as radicular stimulation of the chest wall)
Lead migration or local skin erosion
Implant migration
Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space
Cerebrospinal fluid (CSF) leakage
Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
Persistent pain at the electrode site or IPG site
Seroma (mass or swelling) at the implant site
Allergic or rejection response to implant materials
Product Description
St. Jude Medical™ leads are designed for spinal cord stimulation (SCS) to aid in the treatment of chronic, intractable pain. SCS is a method of pain control that uses low-intensity electrical impulses to stimulate nerve fibers within the spinal cord, often inhibiting chronic pain messages from reaching the brain. Percutaneous leads are designed for introduction into the epidural space using a special needle. The lead assembly consists of 4 or 8 cylindrical electrodes spaced at precise intervals. Percutaneous leads are supplied with a stylet to aid in positioning.
Package Contents
The percutaneous trial lead kits contain the following:
Guide wire.
Used to establish an appropriate pathway for the lead in the epidural space. The guide wire is 50 cm (20 in) in length.
Lead anchor.
Made of silicone and used to secure the lead to connective tissue for stability.
Epidural needle.
Special 14-gauge needle designed for insertion of the percutaneous leads into the epidural space.
Lead stylet.
Inserted in the lead body to assist in steering and positioning.
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Directions for Use
Carefully review the following suggested guidelines for implantation of percutaneous trial leads. If implanting multiple leads, repeat the appropriate steps for each lead. For directions for use for other system components not covered in this document, see the clinician’s manual for the appropriate device.
Placing Percutaneous Leads
Percutaneous trial leads are designed for use during a trial implantation period not to exceed 30 days . They are designed for introduction into the dorsal epidural space using a special needle, guide wire, and the optional Introde-AK™ lead introducer. Each lead is packaged with the
accessories required to place the lead percutaneously. See Appendix A (page 10) for
specifications.
The following are suggested guidelines for placing percutaneous leads. For these instructions, use fluoroscopy as needed to assist in placing a device.
1.
Externally measure and determine the length of lead required to extend from the appropriate spinal level to the predetermined location of the implanted IPG. The appropriate vertebral level for needle entry should be identified and marked (see the following figure) to allow approximately 20 cm (8 in) of the lead to lie in the epidural space. This will facilitate stabilization of the lead and electrodes following implantation. Typical entry levels for lead target sites include the following.
Figure 1. Suggested vertebral entry levels based on target sites
Lead Target Site
T8-T9
T9-T10
T10-T11
T11-T12
T1-T2
C3-C5
C1-C2
Entry Level
T11-T12
T12-L1
L1-L2
L2-L3
T4-T6
T1-T3
C6-C7
2.
CAUTION: Handle the lead with care. The lead can be damaged by mishandling, such as sharp bending, kinking, applying excessive traction, or contact with sharp instruments. Carefully examine each component upon removal from its sterile container. A lead exhibiting signs of damage should not be used.
After appropriate skin prepping, draping, and injection of local anesthetic, insert the epidural needle. A paramedian approach is recommended, and the needle angle should not be greater than 30° (see the following figures). Angles greater than 30° increase the risk of damage to the lead during insertion and manipulation.
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Figure 2. Insert epidural needle using paramedian approach
Figure 3. Insert needle at an angle of 30° or less
1. Spinal cord
2. Ligamentum flavum
3. Epidural space
4. Dural sac
3.
Confirm entry into the epidural space using standard methods such as the loss-of-resistance technique (see the following figure).
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Figure 4. Use loss-of-resistance technique to confirm entry
4.
Under fluoroscopic guidance, insert the guide wire, with the stylet slightly withdrawn, through the needle into the epidural space (see the following figure). Withdrawing the stylet slightly increases the flexibility of the guide wire tip and minimizes the risk of a dural tear.
Figure 5. Insert the guide wire
1. Slightly withdraw the stylet
2. Insert the guide wire
5.
Once the tip of the guide wire is within the epidural space and slightly beyond the distal tip of the needle, fully reinsert the stylet and advance the guide wire to the desired target (see the following figure). When advancing the guide wire, it is very important to do so under fluoroscopic guidance and to manipulate the guide wire carefully to minimize the risk of dural tear.
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Figure 6. Advance the guide wire to the target
1. Fully insert the stylet
2. Advance the guide wire
6.
If using the lead introducer to place the lead (optional), remove the needle using the holdand-push technique, leaving the guide wire in the epidural space (see the following figure).
Figure 7. If using the lead introducer (optional), remove the needle
1. Hold the guide wire
2. Remove the needle
7.
If using the lead introducer (optional), insert the lead introducer over the proximal end of the guide wire at the same angle (no more than 30°) as the previously placed needle (see the following figure). Advance the lead introducer into the epidural space under fluoroscopy to the target position.
NOTE: It may be necessary to rotate the lead introducer as it passes through the ligamentum flavum.
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Figure 8. If using the lead introducer (optional), insert the lead introducer
1. Hold the guide wire
2. Insert the lead introducer
8.
If using the lead introducer (optional), after the lead introducer reaches the desired spinal level for electrode placement, remove the guide wire (see the following figure).
Figure 9. If using the lead introducer (optional), remove the guide wire
1. Hold the lead introducer
2. Remove the guide wire
9.
Insert the lead through the lumen of the needle or the lead introducer (whichever is in place), and advance the lead to the target site under fluoroscopic control (see the following figure). To aid placement, percutaneous leads feature a removable stylet that provides added stiffness and facilitates control.
WARNING: If pulling the lead back through the needle, use caution to avoid severe damage to the lead due to shearing from the needle's tip.
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Figure 10. Insert and advance the lead to the target
1. Hold needle or lead introducer
2. Advance the lead
Figure 11. Use the stylet to help place the lead
1. Stylet
2. Terminal end of lead
10.
11.
Through fluoroscopic evaluation, confirm that the electrodes extend beyond the distal tip of the lead introducer or needle. If they do not, advance the lead or withdraw the lead introducer as necessary to expose the electrodes.
Perform intraoperative testing. See the clinician’s manual for the appropriate trial stimulator for instructions.
2.
3.
Securing the Trial Lead
After the lead has been externalized, it should be connected to the trial cable and secured to the skin to guard against movement during the trial period. For instructions about using the trial cable, see the clinician’s manual for that component.
1.
Once proper lead placement has been confirmed, tape the trial lead securely to the skin with small adhesive strips.
Connect the trial cable to the trial lead if disconnected.
Loop the externalized lead and excess trial cable, and secure it to the patient’s back with an appropriately sized adhesive drape. Leave sufficient trial cable length exposed to allow convenient connection to the trial stimulator.
Disposing of Explanted Components
Explanted St. Jude Medical™ components should be returned to St. Jude Medical for proper disposal. To return an explanted component, place it in a container or bag marked with a biohazard label and coordinate the return with your St. Jude Medical representative or Technical
Support.
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Technical Support
For technical questions and support for your St. Jude Medical™ neuromodulation product, use the following information:
+1 972 309 8000
+1 800 727 7846 (toll-free within North America)
For additional assistance, call your local St. Jude Medical representative.
Appendix A: Product Specifications
NOTE: Not all models are available in all countries. Contact your local representative for more information.
Storage Specifications
Store the components according to the following conditions.
Table 1. Storage conditions for components
Temperature
Humidity
Pressure
Product Materials
-10°C–55°C (14°F–131°F)
10%–90% (noncondensing)
70–150 kPa (10.2–21.8 psi)
Table 2. Product materials for percutaneous leads
Component
Electrodes and terminal end contacts
Insulation
Material
Platinum iridium
Polyurethane
Compatibility Guidelines
Percutaneous leads are compatible with the following devices. For more information on these components, refer to the applicable clinician's manual.
Table 3. Devices compatible with the percutaneous leads
Device
Introde-AK™ lead introducer
SCS accessory kit
Model Number
1103
1701
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Lead Specifications
Table 4. Percutaneous lead specifications
Description Octrode™ Quattrode™ 3/4
Lead length and model
Lead diameter
Electrodes
Number
Length
Longitudinal spacing
Center-to-center spacing
Array length
Lead resistance
60 cm 3086
1.4 mm
8
3 mm
4 mm
7 mm
52 mm
< 10 ohms
Each kit listed in the previous table includes the following items:
1 lead
1 guide wire for percutaneous leads (Model 1102)
1 anchor, butterfly (Model 1105)
1 anchor, long (Model 1106)
1 epidural needle, 14 gauge, 4 in (Model 1114)
NOTE: A standalone accessory is available: epidural needle, 14 gauge, 6 in (Model 1116)
1 stylet, straight (Model 1123)
1 stylet, curved (1124)
3046
1.4 mm
4
3 mm
4 mm
7 mm
24 mm
< 10 ohms
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Appendix B: Regulatory Statements
This section contains regulatory statements about your product.
Declaration of Conformity
Hereby, St. Jude Medical declares that this medical device is in compliance with the essential requirements and other relevant provisions of AIMD directive 90/385/EEC. For a copy of the declaration of conformity, please contact Technical Support.
Appendix C: Symbols and Definitions
The following symbols may be used in this document and on some of the products and packaging:
Table 5. Symbols and definitions
Symbol Definition
Caution, consult accompanying documents
Consult instructions for use
Follow instructions for use on this website
Magnetic Resonance (MR) Unsafe, an item poses unacceptable risks to the patient, medical staff, or other persons within an MR environment
Single use only
Do not resterilize
Expiration date
Date of manufacture
Manufacturing facility
Temperature limits for storage conditions
Humidity limits
Pressure limits
Do not use if the product sterilization barrier or its packaging is compromised
Catalog number
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Table 5. Symbols and definitions
Symbol Definition
Manufacturer
Contents quantity
One lead
Accessories
Serial number
Batch code
Prescription use only
Ethylene oxide gas sterilization
Authorized European representative
European conformity, affixed in accordance with the relevant provisions of AIMD directive 90/385/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive.
Additional Symbols for Product Labels
The following table shows additional symbols that may appear on the product labels for parts related to this kit.
Table 6. Additional symbols for product labels
Symbol Definition
Lead anchor, butterfly
Lead anchor, long
Epidural needle, 14 gauge, 4 in (10 cm)
Epidural needle, 14 gauge, 6 in (15 cm)
Stylet, straight, 60 cm
Stylet, bent, 60 cm
Trial lead kit, 60 cm length
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Appendix D: CE Mark Date
The following table lists the year in which the CE mark was awarded by model number.
Table 7. Year in which CE mark was awarded
Model Year
1102, 1105, 1106, 1114, 1116, 3046, 3086 1999
1123, 1124 2001
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Manufacturer:
St. Jude Medical
6901 Preston Road
Plano, Texas 75024
USA
+1 972 309 8000
Manufacturing Site:
St. Jude Medical Puerto Rico LLC
Lot A Interior - #2 Rd Km. 67.5
Santana Industrial Park
Arecibo, PR 00612
USA sjm.com
European Authorized Representative:
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
Manufacturing Site:
St. Jude Medical Operations (M) Sdn. Bhd.
Plot 102, Lebuhraya Kampung Jawa,
Bayan Lepas Industrial Zone
11900 Penang
Malaysia
Australian Sponsor:
St. Jude Medical Australia Pty. Limited
17 Orion Road
Lane Cove NSW 2066
Australia
*100154383*
2017-02
ARTEN100154383 A
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