Q4D-SC5232SC-5232

Indications for Use Indications for Use 90668223-01 Rev A 1 of 2 Indications for Use The Boston Scientifi c Precision Spectra™ Spinal Cord Stimulator System (Precision Spectra 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. Refer to the Information for Prescribers manual for contraindications, warnings, precautions, adverse events summary, Physician Instructions, sterilization, component disposal, contact information for Boston Scientifi c, information regarding the Patient Identifi cation card, FCC rules and clinical studies supporting clinical use of the neuromodulation system. Refer to the following Directions for Use (DFU) for device specifi c instructions: Precision Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. Indications for Use Indications for Use 90668223-01 Rev A 2 of 2 Boston Scientifi c Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355, USA 866.360.4747 in US and Canada +1 661.949.4747 Phone +1 661.949.4022 Fax 866.789.6364 TTY www.bostonscientifi c.com Email: [email protected] © 2012 Boston Scientifi c Corporation or its affi liates. All rights reserved. 90668223-01 Rev A 2012-04

PRECISION SPECTRA™ SYSTEMINFORMATION FOR PATIENTS Part No. 90668560-01 Rev B This page intentionally left blank. Information for Patients CAUTION:Federal law restricts this device to sale, distribution and use by or on the order of a physician. Part No. 90668560-01 Rev B Information for PatientsPrecision Spectra™ System Information for Patients90668560-01 Rev B ii of iiCopyright©2012 Boston Scienti fi c Corporation or its af fi liates. All Rights Reserved. These documents are the property of Boston Scienti fi c Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scienti fi c Corporation.GuaranteesBoston Scienti fi c reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity.Drawings are for illustration purposes only.Refer to the Precision Spectra™ System Patient Trial Handbook, Precision Spectra System Remote Control Handbook, Charger Handbook, and Limited Warranty for additional instructions and information on your Spinal Cord Stimulation System. Precision Spectra™ System Information for Patients 90668560-01 Rev B 1 of 32 Table of Contents Safety Information .................................................................................................2 Indications for Use ........................................................................................................... .............2 Precision Spectra System Clinical Summary ................................................................................2 Table 1: Summary of Risks Identi fi ed in the Retrospective Clinical Studies ..............................7 Table 2: Clinical Experience Safety ........................................................................................... 8 Contraindications ............................................................................................................. ...........10 Warnings ...................................................................................................................... ...............10 Precautions ................................................................................................................... ..............13 Adverse Effects ............................................................................................................... ............17 FCC Rules ............................................................................................................................... ....19 Patient Identi fi cation Card ...........................................................................................................20 End of Programmed Service ..................................................................................................... ..20 IPG Battery Life............................................................................................................... .............21 Contacting Boston Scienti fi c .............................................................................22 Glossary ...............................................................................................................23 Precision Spectra™ System Information for Patients90668560-01 Rev B 2 of 32 Safety InformationIndications for UseThe Boston Scienti fi c Precision Spectra™ 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 Spectra System Clinical SummaryDetermination of the safety and effectiveness of the Precision Spectra System was based on available published clinical studies for similar implanted spinal cord stimulation systems. The Precision Spectra 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 Spectra System for the treatment chronic intractable pain of the 1 Safety Information Precision Spectra™ System Information for Patients 90668560-01 Rev B 3 of 32 trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.Ef fi cacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the Precision Spectra™ 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. 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 Precision Spectra 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 Pro fi le), isometric lower extremity testing, and patient questionnaires. An intent-to-treat analysis was performed. After patients had SCS for 24 months, Informati…

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CAUTION: Federal law restricts this device to sale, distribu- tion and use by or on the order of a physician. Precision Spectra™ System Information for Prescribers 90668515-01 REV A Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A ii of iv Copyright © 2012 Boston Scientifi c Corporation or its affi liates. All Rights Reserved. These docu- ments are the property of Boston Scientifi c Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scientifi c Corporation. Guarantees Boston Scientifi c Corporation reserves the right to modify, without prior notice, infor- mation relating to its products in order to improve their reliability or operating capacity. Trademarks Precision Spectra is a trademark of Boston Scientifi c. Other brands and their products are trademarks or registered trademarks of their respective holders and should be noted as such. Table of Contents Precision Spectra™ System Information for Prescribers 90668515-01 Rev A iii of iv Refer to the Indications for Use for indications and related information. Refer to the following Directions for Use (DFU) for device specifi c instructions: Precision Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. Table of Contents Device and Product Description .................................................................. 1 Precision Spectra System Clinical Summary........................................................ 1 Contraindications ........................................................................................... 6 Safety Information .......................................................................................... 6 Instructions for the Patient ..................................................................................................6 Adverse Effects ................................................................................................................. 10 Instructions for the Physician ............................................................................................ 11 Sterilization ....................................................................................................................... 12 FCC Rules.......................................................................................................13 Technical Service...........................................................................................13 End of Programmed Service........................................................................14 IPG Battery Life.............................................................................................14 Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A iv of iv This page intentionally left blank. Device and Product Description Precision Spectra™ System Information for Prescribers 90668515-01 Rev A 1 of 15 Device and Product Description The Precision Spectra™ Spinal Cord Stimulation System consists of an Implantable Pulse Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads, Lead Extensions, OR Cables, Trial Stimulator, Remote Control, Clinician Programmer, and Programming Wand, each packaged as a separate kit. Single use accessories and disposable tools are also included in these kits. Features of the Precision Spectra System include: • Stimulation electrode fi eld navigation • Thirty-two independent current-controlled electrodes • Four programmable stimulation areas per program; sixteen possible programs • Long-life operation • High-range parameter capability • Small size • Two-foot programming range • This product contains no detectable latex Precision Spectra System Clinical Summary Determination of the safety and effectiveness of the Precision Spectra System was based on available published clinical studies for similar implanted spinal cord stimulation systems. The Precision Spectra 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 Spectra System for the treatment 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 and leg pain. Effi cacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the Precision Spectra™ 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. 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 Precision Spectra System. Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A 2 of 15 The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS in patients with intractable leg pain. Forty patients wer…

Text truncated - open the document above for the full version.

Indications for Use Indications for Use 90668223-01 Rev A 1 of 2 Indications for Use The Boston Scientifi c Precision Spectra™ Spinal Cord Stimulator System (Precision Spectra 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. Refer to the Information for Prescribers manual for contraindications, warnings, precautions, adverse events summary, Physician Instructions, sterilization, component disposal, contact information for Boston Scientifi c, information regarding the Patient Identifi cation card, FCC rules and clinical studies supporting clinical use of the neuromodulation system. Refer to the following Directions for Use (DFU) for device specifi c instructions: Precision Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. Indications for Use Indications for Use 90668223-01 Rev A 2 of 2 Boston Scientifi c Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355, USA 866.360.4747 in US and Canada +1 661.949.4747 Phone +1 661.949.4022 Fax 866.789.6364 TTY www.bostonscientifi c.com Email: [email protected] © 2012 Boston Scientifi c Corporation or its affi liates. All rights reserved. 90668223-01 Rev A 2012-04

PRECISION SPECTRA™ SYSTEMINFORMATION FOR PATIENTS Part No. 90668560-01 Rev B This page intentionally left blank. Information for Patients CAUTION:Federal law restricts this device to sale, distribution and use by or on the order of a physician. Part No. 90668560-01 Rev B Information for PatientsPrecision Spectra™ System Information for Patients90668560-01 Rev B ii of iiCopyright©2012 Boston Scienti fi c Corporation or its af fi liates. All Rights Reserved. These documents are the property of Boston Scienti fi c Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scienti fi c Corporation.GuaranteesBoston Scienti fi c reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity.Drawings are for illustration purposes only.Refer to the Precision Spectra™ System Patient Trial Handbook, Precision Spectra System Remote Control Handbook, Charger Handbook, and Limited Warranty for additional instructions and information on your Spinal Cord Stimulation System. Precision Spectra™ System Information for Patients 90668560-01 Rev B 1 of 32 Table of Contents Safety Information .................................................................................................2 Indications for Use ........................................................................................................... .............2 Precision Spectra System Clinical Summary ................................................................................2 Table 1: Summary of Risks Identi fi ed in the Retrospective Clinical Studies ..............................7 Table 2: Clinical Experience Safety ........................................................................................... 8 Contraindications ............................................................................................................. ...........10 Warnings ...................................................................................................................... ...............10 Precautions ................................................................................................................... ..............13 Adverse Effects ............................................................................................................... ............17 FCC Rules ............................................................................................................................... ....19 Patient Identi fi cation Card ...........................................................................................................20 End of Programmed Service ..................................................................................................... ..20 IPG Battery Life............................................................................................................... .............21 Contacting Boston Scienti fi c .............................................................................22 Glossary ...............................................................................................................23 Precision Spectra™ System Information for Patients90668560-01 Rev B 2 of 32 Safety InformationIndications for UseThe Boston Scienti fi c Precision Spectra™ 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 Spectra System Clinical SummaryDetermination of the safety and effectiveness of the Precision Spectra System was based on available published clinical studies for similar implanted spinal cord stimulation systems. The Precision Spectra 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 Spectra System for the treatment chronic intractable pain of the 1 Safety Information Precision Spectra™ System Information for Patients 90668560-01 Rev B 3 of 32 trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.Ef fi cacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the Precision Spectra™ 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. 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 Precision Spectra 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 Pro fi le), isometric lower extremity testing, and patient questionnaires. An intent-to-treat analysis was performed. After patients had SCS for 24 months, Informati…

Text truncated - open the document above for the full version.

CAUTION: Federal law restricts this device to sale, distribu- tion and use by or on the order of a physician. Precision Spectra™ System Information for Prescribers 90668515-01 REV A Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A ii of iv Copyright © 2012 Boston Scientifi c Corporation or its affi liates. All Rights Reserved. These docu- ments are the property of Boston Scientifi c Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scientifi c Corporation. Guarantees Boston Scientifi c Corporation reserves the right to modify, without prior notice, infor- mation relating to its products in order to improve their reliability or operating capacity. Trademarks Precision Spectra is a trademark of Boston Scientifi c. Other brands and their products are trademarks or registered trademarks of their respective holders and should be noted as such. Table of Contents Precision Spectra™ System Information for Prescribers 90668515-01 Rev A iii of iv Refer to the Indications for Use for indications and related information. Refer to the following Directions for Use (DFU) for device specifi c instructions: Precision Spectra System Implantable Pulse Generator DFU, Surgical Leads DFU, Percutaneous Leads DFU, Precision Spectra System Clinician Remote Control DFU, Clinician Trial Manual, Precision Spectra System Programming Manual, and Programming Wand DFU. Refer to the Limited Warranty for warranty information. Table of Contents Device and Product Description .................................................................. 1 Precision Spectra System Clinical Summary........................................................ 1 Contraindications ........................................................................................... 6 Safety Information .......................................................................................... 6 Instructions for the Patient ..................................................................................................6 Adverse Effects ................................................................................................................. 10 Instructions for the Physician ............................................................................................ 11 Sterilization ....................................................................................................................... 12 FCC Rules.......................................................................................................13 Technical Service...........................................................................................13 End of Programmed Service........................................................................14 IPG Battery Life.............................................................................................14 Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A iv of iv This page intentionally left blank. Device and Product Description Precision Spectra™ System Information for Prescribers 90668515-01 Rev A 1 of 15 Device and Product Description The Precision Spectra™ Spinal Cord Stimulation System consists of an Implantable Pulse Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads, Lead Extensions, OR Cables, Trial Stimulator, Remote Control, Clinician Programmer, and Programming Wand, each packaged as a separate kit. Single use accessories and disposable tools are also included in these kits. Features of the Precision Spectra System include: • Stimulation electrode fi eld navigation • Thirty-two independent current-controlled electrodes • Four programmable stimulation areas per program; sixteen possible programs • Long-life operation • High-range parameter capability • Small size • Two-foot programming range • This product contains no detectable latex Precision Spectra System Clinical Summary Determination of the safety and effectiveness of the Precision Spectra System was based on available published clinical studies for similar implanted spinal cord stimulation systems. The Precision Spectra 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 Spectra System for the treatment 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 and leg pain. Effi cacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the Precision Spectra™ 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. 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 Precision Spectra System. Information for Prescribers Precision Spectra™ System Information for Prescribers 90668515-01 Rev A 2 of 15 The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS in patients with intractable leg pain. Forty patients wer…

Text truncated - open the document above for the full version.

Refer to the Precision Spectra™ System Information for Patients manual for additional information on your Spinal Cord Stimulation System, such as Indications for Use, contraindications, warnings, precautions, adverse effects, storage and handling, device disposal, glossary, information on contacting Boston Scientific, FCC rules, and clinical studies supporting the clinical use of the neurostimulation system.For Implant charging instructions, refer to the Charger Handbook. For Patient Trial instructions, refer to the Patient Trial Handbook. Precision Spectra™ Remote Control Handbook, 90668562-01, Rev C Precision Spectra™ Remote Control Handbook, 90668562-01, Rev C Introduction to the Precision Spectra™ Remote Control 6 How To Use Programs 19 Configuring Stimulation Areas 35 About System Settings 41 Reminders and Messages 47 Using the Remote Control 11 Troubleshooting 55 Table of Contents Page 4 Precision Spectra™ Remote Control Handbook, 90668562-01, Rev C This manual has been color-coded to help you use the Precision Spectra Remote Control while referencing the manual. Programs P Stimulation Areas Main Menu System Settings Select Back Each section is labeled and color-coded throughout INTRODUCTION Page 5 Precision Spectra™ Remote Control Handbook, 90668562-01, Rev C The Precision Spectra Remote Control (RC) is a handheld device that allows you to communicate with and control your Precision Spectra Stimulator. Designed for ease of use, the RC puts you in control of your stimulation therapy. Typically, you will be using the RC to turn stimulation on and off, increase or decrease stimulation strength, and change or modify programs that your healthcare provider has already created for you.Remote Control Buttons ............ 7Remote Control Screen .............. 8Home Screen ............................. 9 Page 6 Introduction to the Precision Spectra™ Remote Control Precision Spectra™ Remote Control Handbook, 90668562-01, Rev C Buttons are located on the face and sides of the RC as shown in the picture. On the right-hand side of the RC you will find the Lock/Unlock button . On the left hand side you will find the HOME button and Programs button P . On the face of the RC you will find the Stimulation buttons closest to the screen. The Stimulation buttons include the Stimulation ON/OFF button and the and buttons. Below the Stimulation buttons are the Navigation buttons , which allow you to navigate through various menus. n n Home Programs Lock / Unlock Navigation Buttons Stimulation Buttons INTRODUCTION Page 7 Remote Control Buttons Page 8 Precision Spectra™ Remote Control Handbook, 90668562-01, Rev C The RC screen displays menus, icons, status messages, error messages, and other information. When the RC is not in use (for example, the buttons are not being pressed), the screen automatically darkens after approximately 1 mi…

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