Physician Lead Manual DRAFT CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
Physician Lead Manual Copyright ©2004 by Advanced Bionics Corporation. All Rights Reserved. Any 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.
Table of Contents Table of Contents Introduction ............................................... 1 Manual Overview ........................................................... 1 Product Description .......................................................... 1 Indications for Use ........................................................... 3 Precision System Clinical Summary ..................................... 3 Contraindications ..........................................................
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 ...................................................
Introduction 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 Stimulation (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.
Physician Lead Manual inserted into the lead. The lead can be connected to either an extension 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.
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.
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 effectiveness of the PRECISION System (Ohnmeiss et al. 1996, Villavincencio et al. 2000, Hassenbach SJ et al. 1995). The studies included a total of 116 patients that were implanted with an SCS system.
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.
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 effective pain relief.
Introduction Table 1: Summary of Risks Identified in the Retrospective Clinical Studies Risks # Patients With Adverse Event Intent-toTreat 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 Stimulation, Ineffective Pain Control 46 4.4% 5.2% Intermittent Stimulation 0 0% 0% Pain Over Implant 16 1.5% 1.
Physician Lead Manual Clinical Experience-Safety Clinical data has been collected during a clinical study of the PRECISION™ System. As of January 15, 2004, 35 subjects were enrolled in the study at multiple sites and 26 subjects had a successful trial stimulation 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.
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.
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, 46:399406, 2000.
Safety Information 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.
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.
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.
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.
Safety Information ure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control. • Tissue reaction to implanted materials can occur. • Skin erosion or seroma at the IPG site can occur over time.
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 concurrent electrical therapies. Postural Changes. Depending on the activity level of the patient, postural changes may affect stimulation intensity.
Package Contents 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) Tempo
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 package before opening the package and using the contents.
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 hemostats or scalpels to prevent damaging the lead. • Wipe off any body fluids from the lead connector end before connecting it to any other component.
Physician Lead Manual Guidelines for Trial-phase Implantation This section details the recommended procedures for trial-phase temporary implantation of the lead. Pre-op Instructions 20 • Check that the sterile package is intact. (See “Sterilization” 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.
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.
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 fluoroscopic guidance. A sufficient length of lead (i.e.
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 during the trial phase. CAUTION: Do not immerse the OR cable connector or plug in water or other liquids.
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) position. 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. 3.
Guidelines for Trial-phase Implantation 4. Once the needle tip is exposed, hold the lead as close to the percutaneous 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 stabilize 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 nonabsorbable suture around the center groove of the sleeve to prevent sliding.
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. • 30 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.
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 connectors. 11. Place a small loop at the lead for slack.
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.
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.
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.
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 locking 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 turning clockwise.
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. 44 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.
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.
Specifications and Technical Data Lead Extension Part Specifications Model Number SC-3108 Extension Lengths 15, 25, 35 cm Extension Diameter 1.
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.
Technical Service Technical Service Advanced Bionics Corporation has highly trained service professionals located worldwide to assist you. The Technical Service Department is available to provide technical consultation 24 hours a day. In North America please call (866) 566-8913 to speak to a representative.
Physician Lead Manual Limited Warranty Advanced Bionics® Corporation warrants to the patient that the Linear 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.
Limited Warranty a. 5. This warranty does not include surgical accessories used with the Linear Lead or Extension. 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.
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 subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received including interference that may cause undesired operation. The Precision™ System components should only be serviced by Advanced Bionics.
