Boston Scientific Neuromodulation PSC5210W Precision SCS System Remote Control User Manual II Physicians Lead and Extension

Boston Scientific Neuromodulation Corporation Precision SCS System Remote Control II Physicians Lead and Extension

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Physician Lead Manual

CAUTION:

Federal law restricts this device to sale, distribution and use by or on

the order of a physician.

MP9055183 Rev A

DRAFT

Physician Lead Manual

copying, reproduction or translation of all or part of the contents of

this document without the express written permission of Advanced

Bionics Corporation is strictly forbidden by the provisions of the law

of March 11th, 1957.

Guarantees

Advanced Bionics Corporation reserves the right to modify, without

prior notice, information relating to its products in order to improve

their reliability or operating capacity.

Registered Trademarks

Linear™, BionicNavigator™ and Precision™ are registered trademarks

of Advanced Bionics Corporation. Velcro® is a registered mark of

Velcro Industries, Manchester, New Hampshire. Other brands and

their products are trademarks or registered trademarks of their respec-

tive holders and should be noted as such.

Table of Contents

Introduction ............................................... 1

Manual Overview ........................................................... 1

Product Description .......................................................... 1

Indications for Use ...........................................................3

Precision System Clinical Summary .....................................3

Contraindications ..........................................................10

Safety Information ................................... 11

Warnings .................................................................... 11

Precautions .................................................................. 12

Adverse Effects .............................................................14

Instructions for the Physician .............................................16

Package Contents .................................... 17

Lead Kit - Model SC-2108 ............................................. 17

Lead Extension Kit - Model SC-3108 ................................17

Sterilization and Handling ........................ 18

Sterilization ..................................................................18

Handling .....................................................................18

Storage .......................................................................19

Guidelines for Trial-phase Implantation .... 20

Pre-op Instructions ..........................................................20

Lead Placement ............................................................ 21

Connecting the OR Cable Assembly ................................. 23

Intraoperative Stimulation Testing ......................................26

OPTION A: Temporary Lead Trial .................................... 26

OPTION B: Permanent Lead Trial ..................................... 28

Physician’s Lead and Extension Manual

Connecting to the Trial Stimulator ............. 36

Guidelines for Permanent Implantation .... 38

Percutaneous Lead/Extension Removal ..............................38

IPG Implantation ...................................... 40

Tool Assembly .............................................................. 41

Tunneling The Lead ........................................................ 41

Connecting To the IPG ...................................................45

Specifications and Technical Data ............. 48

Lead ..........................................................................48

Lead Extension ............................................................. 49

Registration Information .......................... 50

Technical Service ...................................... 51

Limited Warranty ..................................... 52

Introduction

Manual Overview

This manual provides basic information for the implantation and use

of the Advanced Bionics® Lead Model SC-2108 and Lead Extension

Model SC-3108. These products are designed to be percutaneously or

surgically implanted for use with the PrecisionTM Spinal Cord Stimu-

lation (SCS) System to aid in the management of chronic intractable

pain. Information on other system components and their operation can

be found in the BionicNavigatorTM Software Guide.

General surgical guidelines are presented for temporary and perma-

nent implantation of leads and extensions.

Product Description

Lead

The lead functions as a component of the Precision system by deliver-

ing electrical stimulation to the nerve structures in the dorsal aspect of

the spinal cord, resulting in an inhibition of pain sensation.

Model SC-2108 has eight electrode contacts located near the distal

end. Each contact is 3 mm in length and is spaced 1 mm from the

adjacent contact. The lead body is made of medical grade polyure-

thane with a stiffer proximal end to aid insertion into the connector.

To aid in intraoperative testing and positioning, a curved stylet is pre-

Physician Lead Manual

inserted into the lead. The lead can be connected to either an exten-

sion or directly to an implantable pulse generator (IPG).

Lead Extension

Lead Extension Model SC-3108 is designed to connect the Lead

Model SC-2108 to the Advanced Bionics Precision implantable pulse

generator for spinal cord stimulation. The extension may be added to

Introduction

a lead to externalize the lead for a trial phase or to extend a lead when

a permanent IPG is implanted.

Indications for Use

The Advanced Bionics Precision™ Spinal Cord Stimulator System

(Precision System) is indicated as an aid in the management of

chronic intractable pain of the trunk and/or limbs, including unilateral

or bilateral pain associated with the following: failed back surgery

syndrome, intractable low back pain and leg pain.

Precision System Clinical Summary

Determination of the safety and effectiveness of the PRECISION Sys-

tem was based on available published clinical studies for similar

implanted spinal cord stimulation systems. The PRECISION System

is similar to the SCS systems reported in published literature in

intended use, target patient population, technology, device design, and

output characteristics. Therefore, the clinical data from the published

literature described below represents evidence supporting the safety

and effectiveness of the PRECISION System for the treatment

chronic intractable pain of the trunk and/or limbs, including unilateral

Physician Lead Manual

or bilateral pain associated with the following: failed back surgery

syndrome, intractable low back and leg pain.

Efficacy Evaluation

Three (3) clinical literature studies were used to support the effective-

ness of the PRECISION System (Ohnmeiss et al. 1996, Villavincen-

cio et al. 2000, Hassenbach SJ et al. 1995). The studies included a

total of 116 patients that were implanted with an SCS system. A total

of approximately 3166 device months of experience was depicted

from the retrospective clinical evaluation. All three studies examined

the effectiveness of SCS on patients with chronic pain of the trunk

and/or limbs including unilateral or bilateral pain associated with the

following: failed back surgery syndrome or intractable low back and

leg pain. In all studies, a totally implantable spinal cord stimulator

was used in association with a percutaneous and/or surgical lead.

These studies provide the same diagnostic or therapeutic intervention

for the same disease/conditions and patient population as the PRECI-

SION System.

The prospective study by Ohnmeiss et al. 1996, examined the long-

term effectiveness of SCS in patients with intractable leg pain. Forty

patients were implanted with SCS systems and evaluated at 6 weeks,

12 months, and 24 months follow-up. Outcome measures included the

VAS, pain drawings, medication use, SIP (Sickness Impact Profile),

isometric lower extremity testing, and patient questionnaires. An

intent-to-treat analysis was performed. After patients had SCS for 24

months, leg pain, pain when walking, standing pain, pain’s effect on

overall lifestyle, and the total analog scale scores were significantly

improved from baseline. In this study, 25% of the implanted patients

had greater than 50% improvement in pain rating.

In addition, 3 patients from this study had their stimulators reposi-

tioned due to pain at the original location. Three patients had reopera-

tions to adjust lead position; 1 patient required 2 reoperations, 1

patient had the device removed due to infection and later to have a

new device implanted. A diabetic patient had skin problems which

Introduction

required device removal; a new device was later implanted. Two

patients had the device removed due to unsatisfactory pain relief.

The prospective study performed by Villavicencio et al. 2000

included 41 patients with pain of various etiologies. The majority of

the patients, 24 (59%), had Failed Back Surgery Syndrome (FBSS), 7

(17%) had Complex Regional Pain Syndrome (CRPS I and II), 4

(10%) had neuropathic pain syndrome, and 6 (15%) were diagnosed

as stroke or other. Patients underwent an initial trial period for SCS

with temporary leads. If the trial resulted in greater than 50% reduc-

tion in the patient’s pain, as measured by the VAS, the patient was

implanted with a SCS system. In this study, 27/41 patients, 66%, had

permanent implants. All patients were examined after 6 weeks. Pain

measurements were assessed at 3-6 month intervals for the first year

and annually thereafter. The median long-term follow-up was 34

months. A total of 24/27 (89%), reported greater than 50% reduction

in pain. Since the majority of the patients were treated for FBSS, this

article supports the use of SCS for the treatment of FBSS.

In this study, one patient required a revision because of electrode frac-

ture. One patient required removal of the system due to local infec-

tion. One patient required replacement of the IPG due to mechanical

failure. Overall, 16 of 27 (59%) patients required a total of 36 reposi-

tioning procedures.

A retrospective analysis performed by Hassenbusch SJ et al. 1995

included patients with chronic lower body pain, predominately neuro-

pathic pain and pain either midline lower back and/or unilateral or

bilateral leg pain treated over a 5 year period. The study was a com-

parison of SCS to spinal infusion of opiods. For patients with radicu-

lar pain involving one leg with or without unilateral buttock pain, a

trial of SCS was recommended first. For patients with midline back

pain and /or bilateral leg pain, a trial of long-term spinal infusion was

recommended first. If the patients failed screening with either of these

modalities, the other was then tested. If the treatment reduced the pain

by 50%, the systems were internalized. A retrospective analysis of

Physician Lead Manual

patients with unilateral leg and/or buttock pain treated initially with

SCS and bilateral leg or mainly low back pain treated initially with

spinal infusions of opioids was then done.

In this study, 42 patients were screened; 26 (62%) patients received

spinal stimulation; 16 (38%) received opioids via a spinal infusion

pump. Five patients did not receive adequate pain relief with SCS; 3

(7%) of these patients underwent trial spinal infusions and had effec-

tive pain relief. There were 4 (10%) patients who underwent a trial of

spinal infusion of opioid but did not receive adequate pain relief;

these patients were not tested with SCS. Pain severity was rated using

a verbal digital pain scale: “On a scale of 0 to 10 where 0 is no pain

and 10 is the worst pain you could ever imagine, what is your pain

now?” 16/26 patients (62%) had greater than 50% pain relief with

SCS. In this study, 2/16 (13%) had greater than 50% pain relief with

opioids. Mean follow-up was 2.1 + 0.3 years. This analysis supports

the use of SCS for intractable low back and leg pain.

In this study, 7 (17%) patients suffered complications after implanta-

tion of the device; 5 (12%) patients required repositioning of catheter

type electrodes and 2 patients required revision of the stimulator gen-

erator.

Safety Evaluation

Eleven studies were identified based on the detailed inclusion/exclu-

sion criteria to demonstrate the safety of the PRECISION System.

The studies included a total of 1056 patients that were trialed with

SCS systems and 880 patients that received implants. The table below

depicts the number of patients, the number of events, and the percent-

age of occurrences of each event compared to the total number of

patients. It should be noted that citations cover both IPG and RF Sys-

tems. The clinical experience reported in the literature on RF systems

is relevant to determining the safety of totally implantable IPG sys-

tems.

Introduction

Table 1: Summary of Risks Identified in the Retrospective

Clinical Studies

Risks

# Patients

With

Adverse

Event

Intent-to-

Treat Basis

N = 1056

Implanted

Patient

Basis

N = 880

Lead Migration 175 16.6% 19.9%

Infection 39 3.7% 4.4%

Epidural Hemorrhage 0 0% 0%

Seroma 0 0% 0%

Hematoma 1 0.1% 0.1%

Paralysis 0 0% 0%

CSF Leak 5 0.5% 0.6%

Over/Under Stimula-

tion, Ineffective Pain

Control

46 4.4% 5.2%

Intermittent Stimula-

tion

00%0%

Pain Over Implant 16 1.5% 1.8%

Allergic Reaction 6 0.6% 0.7%

Skin Erosion 0 0% 0%

Lead Breakage 35 3.3% 4.0%

Hardware Malfunction 22 2.1% 2.5%

Loose Connection 0 0% 0%

Battery Failure 2 0.2% 0.2%

Other 45 4.3% 5.1%

Physician Lead Manual

Clinical Experience-Safety

Clinical data has been collected during a clinical study of the PRECI-

SION™ System. As of January 15, 2004, 35 subjects were enrolled in

the study at multiple sites and 26 subjects had a successful trial stimu-

lation period and were implanted with the PRECISION™ System.

The follow-up period for the 26 implanted patients ranged from two

weeks to six months. The following major adverse events were

reported.

Table 2: Clinical Experience Safety

Other minor adverse events reported by at least one patient included:

receiver malfunction, skin irritation, unpleasant stimulation, CSF

leak, infection at implant site, lead migration, and OR cable malfunc-

tion. Two of the subjects reported multiple events.

References

Burchiel, K.J., V.C. Anderson, F.D. Brown, R.G. Fessler, W.A.

Friedman, S. Pelofsky, R.L. Weiner, J. Oakley,and D. Shatin.

“Prospective, Multicenter Study of Spinal Cord Stimulation for

Relief of Chronic Back and Extremity Pain.” Spine, 21:2786-

2793, 1996.

Type Number of Patients Resolution

Lead Migration 1 Lead repositioning

and subsequent

replacement

Output malfunction 1 Device replaced

Infection 1 Infection treated

Pain 1 Lead explanted

Introduction

Hassenbusch, S.J., M. Stanton-Hicks, E.C. Covington. “Spinal cord

stimulation verses spinal infusion for low back and leg pain”.

Acta Neurochirgica, 64:109-115, 1995.

Kemler, M.A., G.A.M. Barendse, M. Van Kleef, H.C.W. De Vet,

C.P.M. Rijks, C.A. Furnee and F.A.J.M. Van den Wilderberg.

“Spinal Cord Stimulation in Patients with Chronic Reflex

Sympathetic Dystrophy.” New England J of Medicine, 343:

618-24, 2000.

Kim S. H., R.R. Tasker, and M.Y. Oh. “Spinal Cord Stimulation for

Nonspecific Limb Pain versus Neuropathic Pain and

Spontaneous versus Evoked Pain.” Neurosurgery, 48(5): 1056-

1064, 2001.

Kumar, K., C. Toth, R. Nath, and P. Lang. “Epidural Spinal Cord

Stimulation for Treatment of Chronic Pain-Some Predictors of

Success. A 15 year experience.” Surg Neurol, 50: 110-120,

1998.

Lang, P. “The Treatment of Chronic Pain by Epidural Spinal Cord

Stimulation.” AXON, 18(4): 71-73, 1997.

Ohnmeiss, D., R. Rashbaum, M. Bogdanffy. Prospective Outcome

Evaluation of Spinal Cord Stimulation in Patients With

Intractable Leg Pain. Spine, 21:1344-1351, 1996.

Rainov, N.G., V. Heidecke, and W. Burkert. “Short Test-Period Spinal

Cord Stimulation for Failed Back Surgery Syndrome.” Minim

Invasive Neurosurg, 39(2):41-44, 1996.

Segal, R., B. Stacey, T. Rudy, S. Basser, J. Markham. “Spinal Cord

Stimulation Revisited.” Neurological Research, 20:391-396,

1998.

Physician Lead Manual

Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A

Contemporary Series.” Neurosurg 28:65-71, 1991.

Villavicencio, A.T., J.C. Leveque, L. Rubin, K. Bulsara, and J.P.

Gorecki. “Laminectomy versus percutaneous electrode

placement for spinal cord stimulation.” Neurosurgery, 46:399-

406, 2000.

Contraindications

Patients contraindicated for permanent SCS therapy are those who:

• are unable to operate the SCS system

• have failed trial stimulation by failing to receive effec-

tive pain relief

• are poor surgical risks

• are pregnant

Safety Information

Warnings

Magnetic Resonance Image (MRI). Patients implanted with the

Precision SCS system should not be subjected to MRI. MRI exposure

may result in dislodgement of implanted components, heating of the

neurostimulator, damage to the device electronics and/or voltage

induction through the leads and stimulator causing an uncomfortable

or “jolting” sensation.

Pediatric Use. The safety and effectiveness of spinal cord stimula-

tion has not been established for pediatric use.

Diathermy. Shortwave, microwave and/or therapeutic ultrasound

diathermy should not be used on SCS patients. The energy generated

by diathermy can be transferred through the stimulator system, caus-

ing tissue damage at the lead site which may result in severe injury or

death. The IPG, whether it is turned on or off, may be damaged.

Implanted Stimulation Devices. Spinal cord stimulators may

interfere with the operation of implanted sensing stimulators such as

pacemakers or cardioverter defibrillators. The effects of implanted

stimulation devices on neurostimulators is unknown.

Implant Damage. Burns may result if the pulse generator case is

ruptured or pierced and patient tissue is exposed to battery chemicals.

Do not implant the device if the case is damaged.

Postural Changes. Patients should be advised that changes in pos-

ture or abrupt movements may cause decreases, or uncomfortable or

painful increases in the perceived stimulation level. Patients should be

advised to turn down the amplitude or turn off the IPG before making

posture changes. If unpleasant sensations occur, the IPG should be

turned off immediately.

Physician Lead Manual

Electromagnetic Interference. Strong electromagnetic fields can

potentially turn the stimulator off, or cause uncomfortable or jolting

stimulation. Patients should be counseled to avoid or exercise care

around:

• Theft detectors or security screeners

• Power lines or power generators

• Electric steel furnaces and arc welders

• Large, magnetized stereo speakers

Precautions

Physician training is required.

Medical Devices/Therapies. The following medical therapies or

procedures may turn stimulation off or may cause permanent damage

to the implant, particularly if used in close proximity to the device:

• lithotripsy

• electrocautery: Do not use monopolar cautery.

• external defibrillation

• radiation therapy

• ultrasonic scanning

• high-output ultrasound

If any of the above is required by medical necessity, refer to “Instruc-

tions for the Physician” on page 16. Ultimately, however, the device

may need to be explanted as a result of associated failure.

Automobiles and Other Equipment. Patients should not operate

automobiles, other motorized vehicles, or potentially dangerous

machinery/equipment with therapeutic stimulation turned on. Stimu-

lation must be turned off first. Sudden stimulation changes, if they

occur, may distract patients from attentive operation of the vehicle or

equipment.

Safety Information

Cell Phones. While we don’t anticipate any interference with cell

phones, the full effects of interaction with cell phones are unknown at

this time.

Post Operative. During the two weeks following surgery, it is

important to use extreme care so that appropriate healing will secure

the implanted components and close the surgical incisions:

Do not exercise or attempt to move heavy objects, and avoid deep

bending and stretching. Temporarily, there may be some pain in the

area of the implant as the incisions heal. If discomfort continues

beyond two weeks, contact your physician.

If you notice excessive redness around the wound areas during this

time, contact your physician to check for infection and administer

proper treatment. In rare cases, adverse tissue reaction to implanted

materials can occur during this period.

Implant Location. Never attempt to change the orientation or “flip”

the implant. Do not “finger” or play with the implant. If the implant

flips over in your body it cannot be charged. If you know that the

device has turned, or if stimulation cannot be turned on after charging,

contact your physician to arrange an evaluation of the system.

In some cases, the skin over your implant may become very thin over

time. If this occurs, contact your physician.

Lead Location. In some instances a lead can move from its original

location, and stimulation at the intended pain site can be lost. If this

occurs, consult your physician who may able to restore stimulation by

reprogramming the implant in the clinic or repositioning the lead

during another operation.

Device Failure. Implants can fail at any time due to random

component failure, loss of battery functionality, or lead breakage. If

the device stops working even after complete charging (up to four

hours), turn off the implant and contact your physician so that the

system can be evaluated.

Physician Lead Manual

Storage. Do not expose the Remote Control or Charging System

components to excessively hot or cold conditions. Do not leave the

devices in your car or outdoors for extended periods of time. The

sensitive electronics can be damaged by temperature extremes,

particularly high heat. If the Remote Control or the Charging System

is to be stored for a period of time, be careful that the storage

temperature does not exceed -20–60 °C (-4–140 °F).

Handling. Handle the system components and accessories with care.

Do not drop them or submerge them in water. Although reliability

testing has been performed to ensure quality manufacturing and

performance, dropping the devices on hard surfaces or in water, or

other rough handling, can permanently damage the components. (See

“Limited Warranty” on page 52.)

Component Disposal. Do not dispose of the Remote Control or

Charger in fire. The battery in these devices can explode in fire.

Dispose of used batteries in accordance with local regulations. The

IPG should be explanted in the case of cremation, and returned to

Advanced Bionics.

Remote Control, Charging System Cleaning. The components

can be cleaned using alcohol or a mild detergent applied with a cloth

or tissue. Residue from soapy detergents should be removed with a

damp cloth. Do not use abrasive cleansers for cleaning.

Adverse Effects

Potential risks are involved with any surgery. In addition to those typ-

ically associated with surgery, possible risks of stimulation system

implantation include:

• Lead migration, resulting in undesirable changes in

stimulation and subsequent reduction in pain relief.

• System failure, which can occur at any time due to ran-

dom failure(s) of the components or the battery. These

events, which may include battery leakage, device fail-

Safety Information

ure, lead breakage, hardware malfunctions, loose con-

nections, electrical shorts or open circuits and lead

insulation breaches, can result in ineffective pain con-

trol.

• Tissue reaction to implanted materials can occur.

• Skin erosion or seroma at the IPG site can occur over

time.

• Possible surgical procedural risks are: temporary pain at

the implant site, infection, spinal cord compression,

cerebrospinal fluid (CSF) leakage and, although rare,

epidural hemorrhage, seroma, hematoma and paralysis.

• External sources of electromagnetic interference may

cause the device to malfunction and affect stimulation.

• Exposure to MRI can result in heating of tissue, image

artifacts, induced voltages in the neurostimulator and/or

leads, lead dislodgement.

• Undesirable stimulation may occur over time due to cel-

lular changes in tissue around the electrodes, changes in

electrode position, loose electrical connections and/or

lead failure.

• The patient may experience painful electrical stimula-

tion of the chest wall as a result of stimulation of certain

nerve roots several weeks after surgery.

• Over time, the implant may move from its original posi-

tion.

• Weakness, clumsiness, numbness or pain below the

level of implantation.

• Persistent pain at the IPG or lead site.

Physician Lead Manual

Instructions for the Physician

Implanted Stimulation Devices. If other implanted devices are

indicated for the patient, careful screening is required to determine if

safe results can be achieved before permanently implementing con-

current electrical therapies.

Postural Changes. Depending on the activity level of the patient,

postural changes may affect stimulation intensity. Instruct patients to

keep the Remote Control at hand at all times, and ensure that they

understand how to adjust stimulation levels.

Medical Devices/Therapies. If the patient is required to undergo

lithotripsy, electrocautery, external defibrillation, radiation therapy,

ultrasonic scanning, or high-output ultrasound:

• Turn off stimulation at least five minutes before the pro-

cedure or application.

• All equipment, including ground plates and paddles,

must be used as far away from the IPG as possible.

• Bipolar electrocautery is recommended: Do not use

monopolar electrocautery.

• Every effort should be taken to keep fields, including

current, radiation, or high-output ultrasonic beams,

away from the IPG.

• Equipment should be set to the lowest energy setting

clinically indicated.

• Instruct patients to confirm IPG functionality following

treatment by turning on the IPG and gradually increas-

ing stimulation to the desired level.

Package Contents

Lead Kit - Model SC-2108

(1) Lead

(1) Curved Stylet (pre-loaded in Lead)

(1) Straight Stylet

(2) Suture Sleeves

(1) Insertion Needle

(1) Lead Blank

(1) OR Cable Assembly

(2) Lead Position Labels—left and right (non-sterile)

(1) Manual

(1) Product Registration Form

(1) Temporary Patient Identification Card

Lead Extension Kit - Model SC-3108

(1) Lead Extension

(1) Skin Marker

(1) Hex Torque Wrench

(1) Tunneling Tool Assembly

(1) Manual

(1) Product Registration Form

(1) Temporary Patient Identification Card

Physician Lead Manual

Sterilization and Handling

Sterilization

The Advanced Bionics Lead Model SC-2108 and Lead Extension

Model SC-3108 and accessories (except for the Lead Position Labels)

were sterilized with ethylene oxide prior to shipment. Red lines on the

green tape located near the bottom of the inner tray cover indicate

exposure to the sterilization process.

Inspect the condition of the sterilization indicator and the sterile pack-

age before opening the package and using the contents. Do not use the

contents if the indicator lines are not red, if the package is broken or

torn, or if contamination is suspected because of a defective sterile

package seal.

• Do not use any component that shows signs of damage.

• Do not resterilize the package or the contents. Obtain a

sterile package from Advanced Bionics.

• Do not use if “Use Before” date has expired.

Note: The lead, lead extension and accessories are intended for

single use only.

Handling

The lead is designed to perform in the hostile environment of the

human body. Care must be taken to avoid damaging the lead with

sharp instruments or excessive force during surgery. The following

guidelines will help to ensure the longevity of components:

• Do not sharply bend or kink the lead or extension.

• Do not tie suture(s) directly to the lead or extension

body; use the provided suture sleeves.

• Avoid forcing the lead into the epidural space by care-

fully clearing a path using the lead blank.

Sterilization and Handling

• Avoid pulling an implanted lead taut; provide a stress

relief loop at the insertion site to minimize tension on

the lead.

• Avoid handling the lead with sharp instruments; use

only rubber-tipped forceps.

• Take care when using sharp instruments such as hemo-

stats or scalpels to prevent damaging the lead.

• Wipe off any body fluids from the lead connector end

before connecting it to any other component. Fluid con-

tamination of these connections could compromise the

integrity of the stimulation circuit.

• Wipe off any body fluids from the stylet before inserting

or reinserting it into the lead.

Storage

Store components between 5 °C and 40 °C (41 °F–104 °F) in an area

where they are not exposed to liquids or excessive moisture. Temper-

atures outside of the stated range can cause damage.

Physician Lead Manual

Guidelines for Trial-phase Implantation

This section details the recommended procedures for trial-phase tem-

porary implantation of the lead.

Pre-op Instructions

• Check that the sterile package is intact. (See “Steriliza-

tion” on page 18.)

• Ensure that a Trial Stimulator and Patient Trial Kit are

available for use following lead placement. Install a new

6 volt battery (included in the Patient Trial Kit) in the

Trial Stimulator.

• Be sure the Trial Stimulator and Remote Control stimu-

lation settings have been reset. Refer to the IPG manual

for links and resets.

• If monopolar testing is anticipated, place the monopolar/

indifferent electrode (available separately) on the

patient’s shoulder or leg and run the cable to the Trial

Stimulator testing site before the patient is prepped and

draped.

Guidelines for Trial-phase Implantation

Lead Placement

Note: Fluoroscopic evaluation of the lead position during this

procedure will aid the physician in achieving an optimum pain

coverage location, and is recommended.

1. Position, prep and drape the patient in the usual accepted manner.

Inject a local anesthetic at the needle insertion site.

2. Insert the needle into the epidural space with the opening facing

up using an angle of 45° or less.

CAUTION: Use only the insertion needle provided in the

Lead Kit. Other needles may damage the lead. The stamped

number on the needle hub corresponds to the orientation of

the bevel, which must face up. Turning the bevel ventral

(down) may result in lead damage. An angle of more than

45º increases the risk of lead damage.

3. Remove the needle stylet and verify entry into the epidural space

using the standard technique.

Physician Lead Manual

4. OPTIONAL. Under fluoroscopic guidance, insert the lead blank

through the needle and into the epidural space. Advance the lead

blank to the target location, then withdraw the blank.

5. Slowly insert the lead, with stylet, through the needle (lead stylet

should extend completely to the tip of the lead).

6. Advance the lead to the appropriate vertebral level using fluoro-

scopic guidance. A sufficient length of lead (i.e., at least 10 cm,

or approximately three vertebrae) should reside in the epidural

space and aids in lead stabilization.

To facilitate advancement and placement, the lead body may be

rotated.

Guidelines for Trial-phase Implantation

Connecting the OR Cable Assembly

The OR cable extension is designed for temporary connection to the

OR cable to facilitate stimulation testing outside of the sterile field.

After stimulation testing, the cable extension is typically removed and

the OR cable is connected directly to the Trial Stimulator for use dur-

ing the trial phase.

CAUTION: Do not immerse the OR cable connector or plug

in water or other liquids. The OR Cable Assembly is intended

for one-time only use; do not resterilize.

1. If two leads are being implanted, wrap the non-sterile 1-L and 2-

R labels around the cables at the Trial Stimulator to identify lead

connections.

2. Verify that the Trial Stimulator is off.

CAUTION: Always turn the Trial Stimulator off before

connecting or disconnecting the Cable Assemblies.

3. Check that the locking lever on the OR cable connector is in the

open position (0).

4. Slide the proximal end of the lead, with stylet, into the open port

on the OR cable connector.

Physician Lead Manual

5. Push the end of the lead into the port until it stops. Hold the lead

in place while sliding the locking lever to the “1” (locked) posi-

tion.

Note: Once the lead is secured in the connector, the stylet can be

manipulated in, but not removed from, the lead.

Guidelines for Trial-phase Implantation

6. Plug the OR Cable Assembly into the Trial Stimulator socket(s)

labeled 1-L (left) and 2-R (right).

Superior (upper or left) leads connect to socket 1-L. Inferior

(lower or right) leads connect to socket 2-R. If only a single lead

is being used, connect it to 1-L.

Physician Lead Manual

Intraoperative Stimulation Testing

Note: The following steps are for procedural reference only. Please

refer to the BionicNavigator Software Guide for detailed

stimulation testing procedures and guidelines.

1. Test various electrode configurations to obtain paresthesia.

Note: If lead repositioning is necessary, turn stimulation off before

proceeding.

2. When the desired paresthesia is achieved:

• turn the Trial Stimulator off

• unlock each OR cable connector and disconnect from

the lead(s)

• slowly withdraw the stylet(s)

3. Record the lead position by capturing a fluoroscopic image to be

sure the leads have not moved. Retest if necessary. The image

can also be used for a position comparison at closure to ensure

that the leads did not move.

OPTION A: Temporary Lead Trial

1. Hold the lead distal to the needle hub to maintain lead position

during needle removal.

2. Carefully withdraw the insertion needle from the epidural space

by slowly pulling the needle up towards the proximal end of the

lead.

3. Continue to pull the needle back approximately one centimeter at

a time until the needle tip is exposed.

Guidelines for Trial-phase Implantation

4. Once the needle tip is exposed, hold the lead as close to the per-

cutaneous exit site as possible, then carefully pull the needle

completely from the lead.

5. If desired, a small suture may be used to close the wound and sta-

bilize the lead. Place and tape a stress relief loop and dress the

wound.

6. Continue with “Connecting to the Trial Stimulator” on page 36.

Physician Lead Manual

OPTION B: Permanent Lead Trial

Removing the Needle

1. Cut down around the needle to access the supraspinous ligament.

2. Hold the lead distal to the needle hub to maintain lead position

during needle removal.

3. Carefully withdraw the insertion needle from the epidural space

by slowly pulling the needle up towards the proximal end of the

lead.

4. Continue to pull the needle back approximately one centimeter at

a time until the needle tip is exposed.

Guidelines for Trial-phase Implantation

5. Once the needle tip is exposed, hold the lead as close to the tip as

possible, then carefully pull the needle completely from the lead.

Anchoring the Lead

1. Place a suture through the supraspinous ligament or deep fascial

tissue.

2. Slide a suture sleeve over the lead and down to the supraspinous

ligament.

3. Ligate the sleeve onto the lead by tying a 2-0 silk or other nonab-

sorbable suture around the center groove of the sleeve to prevent

sliding.

CAUTION: Do not use polypropylene sutures as they may

damage the suture sleeve. Do not suture directly onto the

lead or use a hemostat on the lead body. This may damage

the lead insulation.

Physician Lead Manual

4. Suture the sleeve to the supraspinous ligament or deep fascia

through the suture sleeve holes.

Tunneling And Connecting Extension

A tunneling tool and straw are provided with the Lead Extension Kit

to facilitate percutaneous tunneling of the lead or extension.

• Attach the tunneling tool handle to the shaft by turning

the locking mechanism clockwise.

Guidelines for Trial-phase Implantation

1. Mark the desired route of the tunnel.

2. Administer the appropriate local anesthetic along the tunneling

path.

3. Make a small incision at the desired exit site.

Physician Lead Manual

4. Create a subcutaneous tunnel from the exit site to the midline

incision until the straw is visible and accessible at the exit point.

5. Unscrew and remove the tool handle.

Guidelines for Trial-phase Implantation

6. Grasp the tip of the tool with one hand while holding the straw in

place with the other hand. Pull the tunneling tool shaft out

through the straw.

7. Push the lead or extension proximal ends through the straw, then

withdraw the straw.

8. Wipe clean the proximal end of the lead, then insert the proximal

end into the extension connector until it stops and the retention

ring (long ring) is under the setscrew.

Note: • If there appears to be an obstruction, use the torque wrench

to loosen (counterclockwise) the setscrew and/or gently

rotate the lead to help advance the proximal end.

•Ensure that the lead is fully inserted before tightening the

setscrew to prevent lead damage.

Physician Lead Manual

9. Using the torque wrench supplied, turn the extension connector

setscrew clockwise until it clicks, indicating lock.

Note: • Ensure that the wrench is fully seated in the setscrew before

tightening.

•The wrench is torque-limited and cannot be overtightened.

10. Form an appropriately-sized pocket using blunt dissection on

either side of midline for coiled excess lead and extension con-

nectors.

11. Place a small loop at the lead for slack. If necessary, loosely tie a

suture around the lead-loop, but do not tighten onto the lead.

Guidelines for Trial-phase Implantation

CAUTION: Tightening sutures directly on the lead can

damage the lead.

12. Carefully remove excess slack by gently pulling the extensions

from the exit wound.

13. Close the midline incision.

14. If desired, a small suture may be used to close the exit wound of

the extension. Place and tape a stress relief loop and dress the

wound.

Physician Lead Manual

Connecting to the Trial Stimulator

1. Wipe fluids off the exposed lead connections.

2. Disconnect and discard the OR cable extension, unless extra

length is needed for trial use.

3. Connect the OR cable(s) to the lead(s) or lead extensions: Slide

the locking lever to “0,” fully insert the end of the extension into

the port, slide the locking lever to “1.”

4. If two leads are used, connect the cable labeled 1-L to the upper

or left lead, and the cable labeled 2-R to the lower or right lead.

Labels are provided.

5. Next, connect the right and left-sided OR cables to the Trial Stim-

ulator, referencing the position labels previously fixed to the

cables.

If only one lead is used, connect the OR cable to 1-L on the Trial

Stimulator.

Connecting to the Trial Stimulator

6. Fit the Velcro® belt to the patient, cut off the excess length, and

place the Trial Stimulator in the belt pocket.

Physician Lead Manual

Guidelines for Permanent Implantation

This section details the procedures for

• tunneling the lead/extension as part of an IPG implant

• connection of lead/extension to the IPG

The Tunneling Tool Assembly used in this procedure is provided with

the Precision device as part of the IPG Kit.

Percutaneous Lead/Extension Removal

Before revising a trial system for chronic stimulation, the exposed

portion of the lead or extension must be removed. The method chosen

from the choices below will depend upon how the patient was pre-

pared for the trial phase.

Remove bandages and properly cleanse the exit site.

Option A. Temporary Lead Removal

1. Clip sutures if used to secure the trial lead(s) in place.

2. Remove the lead(s) completely and discard.

Guidelines for Permanent Implantation

Option B. Extension Removal

1. Open the midline incision to expose the lead and connector.

2. Cut the lead extension at the connector.

3. Pull the lead extension through the tunnel and away from body at

the externalized site.

4. Loosen the connector setscrew using the torque wrench provided.

Disconnect and remove the connector.

Note: Connect a new lead extension, if necessary, to reach the

selected IPG site.

Physician Lead Manual

IPG Implantation

1. Ensure that the area surrounding the lead entry site is incised to a

dimension that will accommodate the tunneling tool. Check that

the lead is securely sutured with the suture sleeve.

2. Select and mark the intended IPG site several inches away from

the previously externalized leads, and create an incision at the top

of the site.

3. Create a subcutaneous pocket no larger than the IPG outline at a

depth of up to 3/4 inch (2.0 cm) from the surface.

Note: • Using the template will help guide the correct pocket sizing.

It is important to keep the pocket small to reduce the

chances of patient manipulation and IPG flipping.

•Implant charging could become ineffective at depths greater

than 3/4 inch (2.0 cm).

IPG Implantation

Tool Assembly

The tunneling tool provided with the IPG includes a shaft extender to

be used for up to two leads (with or without extensions).

1. Attach the handle to the tunneling tool shaft by turning the lock-

ing mechanism clockwise.

Note: For more length, attach the shaft extension to the handle, and

then attach the carrier shaft.

2. Thread the tip cover onto the tunneling tool and tighten by turn-

ing clockwise.

Tunneling The Lead

1. Mark the desired route of the tunnel.

2. Administer the appropriate local anesthetic along the tunneling

path.

Note: Check that the tunneling tool tip is securely threaded onto the

carrier.

Tool Handle

Locking Mechanism

Shaft Extension

Shaft

Carrier Tip Cover

Physician Lead Manual

3. OPTIONAL. If necessary, bend the tool shaft to conform to the

patient’s body.

CAUTION: Do not bend locking joints.

4. Create a subcutaneous tunnel from the IPG site to the midline

incision.

Note: Deep tunneling is not recommended.

IPG Implantation

5. Once the tunneling tip is completely exposed at midline, press it

toward the shaft and turn it counterclockwise to remove it for

access to the carrier.

Note: You may feel the tip slide back before the cover begins to

unscrew.

Physician Lead Manual

6. Carefully position each lead or extension into the carrier shaft

and press the lead/extension into the groove.

Note: If necessary, swivel the carrier by pulling it away from the

handle and turning it to get better access to the cavities.

7. Gently pull the tunneling tool back through the tunnel.

IPG Implantation

8. Gently lift the lead(s) out of the locking groove(s).

9. Wipe off any fluids from the proximal end of the lead(s).

Connecting To the IPG

Before implanting the IPG, refer to the IPG Implant Manual.

Dual Lead Connection

• Superior (upper or left) leads connect to IPG port 1-L.

• Inferior (lower or right) leads connect to IPG port 2-R.

Single Lead Connection

• Connect a single lead to IPG port 1-L.

• Plug port 2-R with the connector plug supplied in the

IPG Kit.

Physician Lead Manual

1. Fully insert the lead(s) into the IPG port(s). When the lead is

properly inserted, the lead will stop and the retention ring will be

located under the setscrew.

2. Pass the torque wrench through the slit in the septum located on

the top of the IPG header and tighten both set screws, one at a

time, until the torque wrench “clicks,” indicating lock.

IPG Implantation

Note: • Ensure that the lead is fully inserted before tightening the

setscrew to prevent lead damage.

•If the connector plug is used in port 2-R, it is still necessary

to tighten the setscrew as described.

•The wrench is torque-limited and cannot be overtightened.

3. Place the IPG in the subcutaneous pocket with “This Side Up”

facing towards the skin.

4. Coil excess lead or extension under the IPG.

Note: To confirm good connections, check impedances before

tightening the setscrew.

5. Secure the IPG in the pocket by suturing through the holes in the

connector.

6. Close and dress the wound(s).

Physician Lead Manual

Specifications and Technical Data

Lead

Part Specifications

Model Number SC-2108

Lead Lengths 30, 50, 70 cm

Lead Shape In-line

Lead Diameter 1.3 mm

Number of Electrode Contacts 8

Electrode Length 3 mm

Electrode Spacing 1 mm

Contact Material Platinum/Iridium

Insulation Material Polyurethane

Conductor Material Shell: MP35N

Core: MP-DFT (28% Ag)

Conductor Resistance < 7 Ohms

Specifications and Technical Data

Lead Extension

Part Specifications

Model Number SC-3108

Extension Lengths 15, 25, 35 cm

Extension Diameter 1.3 mm

Number of Electrode

Contacts

Contact Material Platinum/Iridium, MP35N, Stainless Steel

Insulation Material Polyurethane, Silicone

Conductor Material MP35N

Conductor Resistance < 10 Ohms

Physician Lead Manual

Registration Information

In accordance with international practice and regulatory legislation in

some countries, a registration form is packed with each Advanced

Bionics Corporation lead/lead extension.

The purpose of this form is to maintain traceability of all products and

to secure warranty rights. It also allows the institution involved in the

evaluation or replacement of a specific implanted lead, accessory or

device to gain quick access to pertinent data from the manufacturer.

Fill out the registration form included in the package contents. Return

one copy to Advanced Bionics, keep one copy for patient records, and

provide one copy to the patient and physician.

Advanced Bionics Corporation

25129 Rye Canyon Loop

Valencia, California 91355

Attention: Customer Service Department

Technical Service

Advanced Bionics Corporation has highly trained service profession-

als located worldwide to assist you. The Technical Service Depart-

ment is available to provide technical consultation 24 hours a day.

In North America please call (866) 566-8913 to speak to a representa-

tive.

Physician Lead Manual

Limited Warranty

Advanced Bionics® Corporation warrants to the patient that the Lin-

ear Lead, Model SC-2108, and Extension, Model SC-3108, are free

from defects in workmanship and materials for a period of one (1)

year from the date of implantation.

A Lead or Extension that fails to function within normal tolerances

within (1) year from the date of surgery is covered under this Limited

Warranty. The liability of Advanced Bionics® under this warranty

shall be limited to: (a) replacement with a functionally equivalent

Lead or Extension; or (b) full credit equal to the original purchase

price to be applied towards the purchase of a new Lead or Extension.

Product claims under Advanced Bionics® Limited Warranty are sub-

ject to the following conditions and limitations:

1. The product registration card must be completed and returned to

Advanced Bionics® within 30 days of surgery in order to obtain

warranty rights.

2. The Lead or Extension must be returned to Advanced Bionics®

(or authorized agent) within 30 days of malfunction or discovery

of defect, and shall be the property of Advanced Bionics®.

3. The Lead or Extension must be implanted prior to the “use

before” date.

4. Failure of the Lead or Extension must be confirmed by Advanced

Bionics®. This warranty specifically excludes defects or malfunc-

tions caused by: (a) fire, floods, lightning, natural disasters, water

damage and other calamities commonly defined as “Acts of

God”; (b) accident, misuse, abuse, negligence, or the customer’s

failure to operate the Lead or Extension in accordance with man-

ufacturer's instructions; (c) unauthorized attempts to repair, main-

tain, or modify the equipment by the customer or any

unauthorized third party; or (d) attachment of any equipment not

supplied by Advanced Bionics® without prior approval.

Limited Warranty

a. This warranty does not include surgical accessories used

with the Linear Lead or Extension.

5. The decision as to product replacement or credit shall be made

solely at the discretion of Advanced Bionics®. For a replacement

Lead or Extension, the warranty will run only to the end of the

warranty period for the original Lead or Extension that was

replaced.

This warranty is in lieu of any other warranty, expressed or implied,

including any warranty of merchantability or fitness for intended use.

Except as expressly provided by this Limited Warranty, Advanced

Bionics® shall not be responsible or liable for any direct, consequen-

tial or incidental damages caused by device malfunction, failure or

defect, whether the claim is based on warranty, contract, tort or other-

wise.

Physician Lead Manual

The following is federal government communications regulation

information about the Precision™ System.

This device complies with part 15 of the FCC Rules. Operation is sub-

ject to the following two conditions: (1) This device may not cause

harmful interference, and (2) This device must accept any interfer-

ence received including interference that may cause undesired opera-

tion.

The Precision™ System components should only be serviced by

Advanced Bionics. Do not attempt to open or repair any of the com-

ponents. Unauthorized opening of or attempts to repair the compo-

nents will void the warranty.

Changes of modifications to this product not authorized by Advanced

Bionics Corporation could void the FCC Certification and negate

your authority to operate this product.

Boston Scientific Neuromodulation PSC5210W Precision SCS System Remote Control User Manual II Physicians Lead and Extension

Boston Scientific Neuromodulation Corporation Precision SCS System Remote Control II Physicians Lead and Extension

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