Precision Spectra Information for Prescribers
Contents
1. qBoston clenti Advancing science for life wll Legal Manufacturer Boston Scientific Neuromodulation 25155 Rye Canyon Loop Valencia CA 91355 USA 866 789 5899 in US and Canada 661 949 4000 661 949 4022 Fax 866 789 6364 TTY www bostonscientific com Email neuro info bsci com AUS Australian Sponsor aus Address Boston Scientific Australia Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666 EU Authorised Representative Boston Scientific Limited Ballybrit Business Park Galway Ireland T 33 0 1 39 30 97 00 F 33 0 1 39 30 97 99 2015 Boston Scientific Corporation or its affiliates All rights reserved 91008787 01 REV A 2015 082. B The Precision Spectra System is suitable for use in all establishments Including domestic pamatcemlselele Class B establishments and those directly connected IEC 61000 3 2 to the public low voltage power supply network Voltage fluctuations Complies that supplies buildings used for domestic Flicker emissions IEC purposes 61000 3 3 Precision Spectra System Information for Prescribers 91008787 01 RevA 12of21 Safety Information Guidance and manufacturer s declaration electromagnetic immunity Immunity Test IEC 60601 Test Level Compliance Level The Precision Spectra Spinal Cord Stimulator System is intended for use in the electromagnetic environment specified below The customer or the user of the Precision Spectra Spinal Cord Stimulator System should assure that it is used in such an environment Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8kV air 6 kV contact 8kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV
3. Please contact your healthcare professional Remote Control Charging System External Trial Stimulator and Wand Cleaning The charging system components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue The Remote Control External Trial Stimulator and Programming Wand can be cleaned using a mild detergent applied with a lightly dampened cloth or tissue Residue from soapy detergents should be removed with a cloth lightly dampened with water Do not use abrasive cleansers for cleaning Cleaning wipes for the External Trial Stimulator can also be ordered through Boston Scientific customer service Cell Phones While we do not anticipate any interference with cell phones the full effects of interaction with cell phones are unknown at this time If there is a concern or a problem is encountered the patients should contact their physician Adverse Effects Potential risks are involved with any surgery The possible risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation include e Lead migration resulting in undesirable changes in stimulation and subsequent reduction in pain relief System failure which can occur at any time due to random failure s of the components or the battery These events which may include device failure lead breakage hardware malfunctions loose connections electrical shorts or open circuits and lead insulation breaches can result in ineffective pa
4. Revisited Neurological Research 20 391 396 1998 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 Precision Spectra System Information for Prescribers 91008787 01 RevA 4 of 21 Contraindications Contraindications Patients contraindicated for permanent Spinal Cord Stimulation SCS therapy are those who are unable to operate the SCS system have failed trial stimulation by failing to receive effective pain relief are poor surgical risks are pregnant Safety Information WARNING Unauthorized modification to the medical devices is prohibited System integrity could be compromised and harm or injury to the patient could occur if the medical devices are subjected to unauthorized modification Instructions for the Patient Warnings Heat Due to Charging Patients should not charge while sleeping This may result in a burn While charging the Charger may become warm It should be handled with care Failure to use the Charger with either the Charging Belt or an adhesive patch as shown may result in a burn If patients experience pain or discomfort they should cease charging and contact Boston Scientific Magnetic Resonance Imaging MRI MRI Transmit or T
5. line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for5s lt 5 Ur gt 95 dip in Ux for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for5s Mains power quality should be that of a typical commercial or hospital environment If the user of the Precision Spectra Spinal Cord Stimulator System requires continued operation during power mains interruptions it is recommended that the Precision Spectra Spinal Cord Stimulator System be powered from an uninterruptible power supply or a battery Precision Spectra System Information for Prescribers 91008787 01 RevA 13 of 21 Information for Prescribers Guidance and manufacturer s declaration electromagnetic immunity Power frequency 3 A m 3A m Power frequency 50 60 Hz magnetic fields magnetic field should be at levels IEC 61000 4 8 characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains
6. modifications to this product not authorized by Boston Scientific Corporation could void the FCC Certification and negate your authority to operate this product Technical Service Boston Scientific 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 Precision Spectra System Information for Prescribers 91008787 01 RevA 16 of 21 End of Programmed Service End of Programmed Service The Precision Spectra System IPG software is programmed to end service after 12 years As the IPG nears the end of the programmed period the Precision Spectra System Remote Control and Precision Spectra System Clinician Programmer provide the following indicators to inform the user that end of the programmed period is approaching e Remote Control Approximately six months before the end of programmed period the Remote Control displays a weekly message indicating the number of service days remaining Approximately one month before the end of the programmed period the message displays daily Clinician Programmer When less than six months of service period remain an indicator displays on the Connect screen of the Clinician Programmer When end of the programmed period has been reached a message displays when connecting to the Stimulator to indicate that end of th
7. voltage prior to application of the test level Recommended separation distances between potable and mobile RF communications equipment and the Precision Spectra Spinal Cord Stimulator System The Precision Spectra Spinal Cord Stimulator System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Precision Spectra Spinal Cord Stimulator System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Precision Spectra Spinal Cord Stimulator System as recommended below according to the maximum output power of the communications equipment Rated maximum output power of Separation distance according to frequency of transmitter meters transmitter RF emissions 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 80 GHz CISPR 11 d 1 2 P d 1 2 P d 23 P Ww 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters operating below 150 kHz RFID devices such as access control devices the recommended separation distance is at least 1 17 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power r
8. Boston Scientific Advancing science for life Precision Spectra Spinal Cord Stimulator System Information for Prescribers 91008787 01 REVA R ONLY CAUTION Federal law restricts this device to sale distribution and use by or on the order of a physician Information for Prescribers Guarantees Boston Scientific Corporation reserves the right to modify without prior notice information relating to its products in order to improve their reliability or operating capacity Trademarks All trademarks are the property of their respective owners Additional Information For Indications and related information see the Indications DFU For other device specific information not included in this manual labeling symbols and warranty information refer to the appropriate DFU for your SCS System as listed on your Reference Guide Precision Spectra System Information for Prescribers 91008787 01 RevA i ofiii Table of Contents Device and Product Description ccccesseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneneeeeeees 1 Precision Spectra System Clinical Summary ccseeceseeeeeeeeneeteeenseeeees 1 CONTAIN GICAL ONS icosiccse citi eencciindiesnceeieiieudecanideseedecussaueeedad dudeaneevuseuidesaveevuncreds 5 Safety Information ce cccceeeceeeeeeeeeeeeeseeeeseeeeseseeeeeeseneeseeeeseeeseesesseneseseeaeesseeees 5 Instructions for the Patientens iesenssyaniua nr R akiiwun cach wdnacads 5 Adverse Effects Inst
9. al failure Overall 16 of 27 59 patients required a total of 36 repositioning procedures Aretrospective analysis performed by Hassenbusch SJ et al 1995 included patients with chronic lower body pain predominately neuropathic pain and pain either midline lower back and or unilateral or bilateral leg pain treated over a 5 year period The study was a comparison of SCS to spinal infusion of opioids For patients with radicular 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 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 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 te
10. ating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Precision Spectra System Information for Prescribers 91008787 01 RevA 14 0f 21 Safety Information Sterilization All Precision Spectra System implantable and surgical components are sterilized with ethylene oxide e Inspect the condition of the sterile package before opening the package and using the contents Do not use the contents if the package is broken or torn or if contamination is suspected because of a defective sterile package seal Donot use any component that shows signs of damage Do not resterilize the package or the contents Obtain a sterile package from Boston Scientific Do not use if the product is past the labeled expiration date All components are for single use only Do not reuse Do not use if package is opened or damaged Do not use if labeling is incomplete or illegibl WARNING Contents supplied STERILE using an ethylene oxide EO process Do not use if sterile barrier is damaged If damage is found call your Boston Scientific representative Q For Single Use Only Do Not Reuse K Do Not Resterilize S Do not use if package is damaged For si
11. ctra System Information for Prescribers 91008787 01 RevA 9of21 Information for Prescribers Quality of Wireless Service The Precision Spectra uses a Half Duplex direct point to point primary secondary communication system with the following characteristics e Typical range 36 inches 91 4 cm between Remote Control and Stimulator with 95 or higher communication success rate 45 inches 114 3 cm between Wand and Stimulator with 95 or higher communication success rate Timing Once a command is initiated by the user the system will respond in less than 1 5 seconds Telemetry failures The signal to noise ratio is measured before initiating a communication Telemetry failures can occur if signal to noise ratio is low Signal to noise measurement is retried up to three times in case of insufficient range or in presence of interference User is notified of the communication failure after 3 failed attempts Packet and message errors are verified for accuracy Any erroneous packets messages are rejected and re sent up to 3 times User is notified of the communication failure after 3 failed attempts User may re try the command or follow on screen instructions for telemetry help Wireless Security The Precision Spectra System has a short range inductively coupled telemetry system A Remote Control or Wand has to be linked with a stimulator to allow communication The Stimulator will not respond to any device that
12. d strengths should be less than 3 V m Precision Spectra System Information for Prescribers 91008787 01 RevA 19 of 21 Information for Prescribers IPG Battery Life The rechargeable battery in the Precision Spectra System IPG should provide at least five years of service In most cases the Stimulator will need to be recharged at intervals ranging from once a week to once a month Over time the IPG battery will need more frequent recharges Like all rechargeable batteries use over time and repeated recharge cycles reduce the maximum charge capacity of the IPG battery The Precision Spectra System s programming software gives you an estimate of charging time based on 24 hours per day of stimulation at the programmed settings Depending on the program parameters the patient may expect daily recharging times from as low as 10 minutes up to four hours or weekly recharging times from as low as one hour up to four hours The expected years of battery operation are defined as the longer of either A Typical case the time at which therapy cannot be maintained with daily charging OR B High energy case when the maximum recharge interval has decreased by more than 50 from the initial recharge interval Precision Spectra System Information for Prescribers 91008787 01 RevA 200f21 End of Programmed Service This page intentionally left blank Precision Spectra System Information for Prescribers 91008787 01 RevA 21 of 21
13. d www controlyourpain com dfu MRI examinations performed on patients with the Precision Spectra System using open sided MRI systems or other types of MRI systems operating at other static magnetic field strengths higher or lower have not been assessed and as such should not be performed e External Devices Precision Spectra external components i e External Trial Stimulator Remote Control Battery Charger are MR Unsafe They must not be taken into any MR environment such as the MRI scanner room Pediatric Use The safety and effectiveness of spinal cord stimulation has not been established for pediatric use Precision Spectra System Information for Prescribers 91008787 01 RevA 5of21 Information for Prescribers 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 causing tissue damage at the lead site and resulting 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 Stimulator Damage Burns may result if the pulse generator case is ruptured or pierced and patient tissue is exposed to battery chemicals Do not implan
14. e programmed period has been reached and programming is not allowed Patients should contact their health care provider upon first receiving a message regarding the number of programmed service days remaining Precision Spectra System Information for Prescribers 91008787 01 RevA 17 of 21 Information for Prescribers Guidance and manufacturer s declaration electromagnetic immunity The Precision Spectra Spinal Cord Stimulator System is intended for use in the electromagnetic environment specified below The customer or the user of the Precision Spectra Spinal Cord Stimulator System should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Environment guidance Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Precision Spectra Spinal Cord Stimulator System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 2VP IEC 61000 4 6 150 kHz to 150 kHz to 80 80 MHz MHz 3 V m d 1 2 VP 80 MHz to 800 MHz Radiated RF 3 V m 80M Hz to 2 5 IEC 61000 4 3 80MHzto GHz d 2 3 VP 800 MHz to 2 5 GHz 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance
15. el to the point that the sensation is uncomfortably strong or possibly jolting If this happens the patient should turn off the Stimulator If the Stimulator suddenly turns off by itself the patient should first move away from the area Next check the stimulation status with the Remote Control by pressing the Unlock button and observing the screen The implant may need to be recharged before stimulation can be restarted The patient can refer to the Charging Handbook for further information The patient should be counseled to always be aware of his surroundings particularly near theft detectors security screeners He should ask for assistance to go around these devices if he feels at all uncomfortable 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 Stimulator particularly if used in close proximity to the device e lithotripsy electrocautery See Instructions for the Physician on page 9 e external defibrillation e radiation therapy Any damage to the device by radiation may not be immediately detectable e ultrasonic scanning Precision Spectra System Information for Prescribers 91008787 01 RevA 6of 21 Safety Information high output ultrasound X ray and CT scans may damage the Stimulator if stimulation is on X Ray and CT Scans are unlikely to damage the Stimulator if stimulatio
16. eriod Patients should consult their physician before making lifestyle changes due to decreases in pain Stimulator Location Patients should never attempt to change the orientation or flip rotate or spin the Stimulator Patients should not finger or play with the Stimulator If the Stimulator flips over in the Patient s body it cannot be charged If the Patient knows that the device has turned or if stimulation cannot be turned on after charging the Patient should contact his or her physician to arrange an evaluation of the system In some cases the skin over the Stimulator may become very thin over time If this occurs Patients should contact their physicians 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 Patients should consult their physician who may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning the lead during another operation Device Failure Stimulators 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 Patients should turn off the Stimulator and contact their physician so that the system can be evaluated Operating Temperature The operating temperature of the Trial Stimulator Remote Control and Programming Wand is 10 40 C 50 104 F For prope
17. ers The optimal orientation between the Stimulator and Remote Control is illustrated below The Remote Control may be rotated 360 as shown in the illustration and still maintain the same communication range Precision Spectra System Information for Prescribers 91008787 01 RevA 10 of 21 Safety Information Figure 1 Orientation of External Trial Stimulator and Remote Control Figure 2 Orientation of Implantable Pulse Generator and Remote Control The Programming Wand communicates with the Stimulator through a RF telemetry link from a distance of up to 45 inches 114 3 cm Beyond this range the Wand is more likely to experience difficulty communicating commands to the Stimulator Signal strength bars on the Programming Wand indicate the strength of wireless communication between the Stimulator and the Wand The Stimulator Communication Indicator on the Wand flashes when data is successfully transmitted between the stimulator and the Wand If communication fails the Wand beeps up to three times The Clinician Programmer displays an Action unsuccessful message and instructs the user to move the Wand closer to the Stimulator and retry Moving the Wand closer to the Stimulator and or changing the orientation of the Wand can improve communication Common sources of interference such as computers and their power adapters can reduce the wireless range To increase range move the Wand six inches or more from these devices The optimal o
18. ient had skin Precision Spectra System Information for Prescribers 91008787 01 RevA 1 of 21 Information for Prescribers problems which 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 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 reduction 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 fracture One patient required removal of the system due to local infection One patient required replacement of the IPG due to mechanic
19. in Prospective Multicenter Study of Spinal Cord Stimulation for Relief of Chronic Back and Extremity Pain Spine 21 2786 2793 1996 Hassenbusch S J M Stanton Hicks E C Covington Spinal cord stimulation verses spinal infusion for low back andleg 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 CordStimulation 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
20. in control e Tissue reaction to implanted materials can occur In some cases the formation of reactive tissue around the lead in the epidural space can result in delayed onset of spinal cord compression and neurological sensory deficit including paralysis Time to onset is variable possibly ranging from weeks to years after implant Skin erosion at the IPG site can occur over time e Possible surgical procedural risks are temporary pain at the implant site infection cerebrospinal fluid CSF leakage and although rare epidural hemorrhage seroma hematoma and paralysis e 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 cellular changes in tissue around the electrodes changes in electrode position loose electrical connections and or lead failure The patient may experience painful electrical stimulation of the chest wall as a result of stimulation of certain nerve roots several weeks after surgery Over time the Stimulator may move from its original position Weakness clumsiness numbness or pain below the level of implantation e Persistent pain at the IPG or lead site Precision Spectra System Information for Prescribers 91008787 01 RevA 8of 21 Safety Information I
21. in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the symbol shown below Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Precision Spectra System Information for Prescribers 91008787 01 RevA 18 of 21 FCC Rules a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Precision Spectra Spinal Cord Stimulator System is used exceeds the applicable RF compliance level above the Precision Spectra Spinal Cord Stimulator System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Precision Spectra Spinal Cord Stimulator System b Over the frequency range 150 kHz to 80 MHz fiel
22. in the Retrospective Clinical Studies Tiere ea a Adverse Event Basis N 1056 Basis N 880 Epidural Hemorrhage o o sem oo ooo o S Paralysis OHH Ineffective Pain Control Intermittent Stimulation o fo H Allergic Reaction f6 oer OH O Skin Erosion OCHS Loose Connection o o 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 Precision Spectra System Information for Prescribers 91008787 01 RevA 30f21 Information for Prescribers Table 2 Clinical Experience Safety Number of Patients Lead Migration Lead repositioning and subsequent replacement Output malfunction Device replaced Infection Infection treated Pan Lead explanted 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 malfunction 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 Shat
23. it is not linked to There are additional mechanisms that ensure the integrity of the communicated data Telemetry Information Frequency Band 119 131 kHz The Remote Control communicates with the Stimulator ETS or IPG through an RF telemetry link from a distance of up to 36 inches 91 4 cm Beyond this range the RC is more likely to experience difficulty communicating commands to the Stimulator When the RC is unable to communicate a command to the Stimulator it will display a Communication Failed screen and provide two options Retry and Telemetry Help The Retry option resends the last command The Telemetry Help option assists the user in discovering an optimal position to hold the RC to ensure communication with the Stimulator The user may test the Remote Control in different positions and observe which positions produce an acceptable number of signal bars Refer to the Telemetry Help section of the Clinician Remote Control Handbook for more information Reduction of range may occur when in close proximity of sources of interference such as Television and computer monitors Short range RFID electronic tracking systems such as badge scanners and parking lot scanners Reduction of range may also occur within 18 feet of another Precision Spectra System Refer to the tables in the Electromagnetic Interference section to determine the recommended separation distances between the Precision Spectra System and other transmitt
24. n any event instruct the patient to contact their physician to inform him her Instructions for the Physician Implanted Stimulation Devices If such 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 Instruct patients to keep the Remote Control on hand at all times and ensure that they understand how to adjust stimulation levels Refer to Postural Changes in the Instructions for Patients section of this manual page 6 for additional information Medical Devices Therapies If the patient is required to undergo lithotripsy electrocautery external defibrillation radiation therapy ultrasonic scanning high output ultrasound X Ray or CT Scan Turn off stimulation at least five minutes before the procedure or application All equipment including ground plates and paddles must be used as far away from the IPG as possible e Every effort should be taken to keep fields including current radiation or high output ultrasonic beams away from the IPG e Equipment should be set to the lowest energy setting clinically indicated e Instruct patients to confirm IPG functionality following treatment by turning on the IPG and gradually increasing stimulation to the desired level Precision Spe
25. n is turned off If any of the above is required by medical necessity refer to Instructions for the Physician on page 9 Ultimately however the device may require explantation as a result of damage to the device Automobiles and Other Equipment Patients should not operate automobiles other motorized vehicles or potentially dangerous machinery equipment with therapeutic stimulation switched on Stimulation must be turned off first Sudden stimulation changes if they occur may distract patients from attentive operation of the vehicle or equipment Post Operative During the two weeks following surgery it is important that patients use extreme care so that appropriate healing will secure the implanted components and close the surgical incisions e Patients should not lift objects of more than five pounds e Patients should not engage in rigorous physical activity such as twisting bending or climbing e If new leads were implanted patients should not raise their arms above their head Temporarily there may be some pain in the area of the implant as the incisions heal Patients should be instructed that if discomfort continues beyond two weeks they should contact their physician If patients notice excessive redness around the wound areas during this time they should contact their physician to check for infection and administer proper treatment In rare cases adverse tissue reaction to implanted materials can occur during this p
26. ngle patient use only Do not reuse reprocess or resterilize Reuse reprocessing or resterilization may compromise the structural integrity of the device and or lead to device failure which in turn may result in patient injury illness or death Reuse reprocessing or resterilization may also create a risk of contamination of the device and or cause patient infection or crossinfection including but not limited to the transmission of infectious disease s from one patient to another Contamination of the device may lead to injury illness or death of the patient After use dispose of product and packaging in accordance with hospital administrative and or local government policy Precision Spectra System Information for Prescribers 91008787 01 RevA 15 of 21 Information for Prescribers FCC Rules The following is federal government communications regulation information about the Precision Spectra Spinal Cord Stimulator 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 Spectra System components should only be serviced by Boston Scientific Do not attempt to open or repair any of the components Unauthorized opening of or attempts to repair the components will void the warranty Changes of
27. nk 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 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 repositioned due to pain at the original location Three patients had reoperations 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 pat
28. r operation do not use the Charger if the ambient temperature is above 35 C 95 F Storage Handling and Transport 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 without batteries the storage temperature should not exceed 20 to 60 C 4 to 140 F Precision Spectra System Information for Prescribers 91008787 01 RevA 7 of 21 Information for Prescribers Handle the system external 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 these components See Limited Warranty IPG Upon completion of the Patient Trial remove the batteries from the Trial Stimulator 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 Boston Scientific External devices to be disposed of per local regulatory requirements
29. ram sixteen possible programs Long life operation e High range parameter capability Small size Two foot programming range This product was not made with natural 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 Efficacy 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 tru
30. ransmit Receive RF Body Coil Patients implanted with the Precision Spectra System should not be subjected to a MRI transmit or transmit receive RF body coil RF body coil exposure may result in significant heating and or tissue damage especially near the proximal and distal portions of the implant RF body coil exposure can damage the IPG electronics potentially requiring device replacement RF body coil exposure may also cause voltage induction through the leads and stimulator causing unintended stimulation which the patient could experience as a tingling shocking or jolting sensation e MRI Transmit Receive RF Head Coil The Precision Spectra Spinal Cord Stimulator SCS System is MR Conditional An MRI examination of the head only no other part of the body can be conducted safely using only a 1 5 Tesla horizontal closed bore whole body MRI system that is configured to use its 1 5T transmit receive radio frequency RF head coil for the MRI scan when all instructions in the supplemental manual ImageReady MRI Guidelines for Precision Spectra Spinal Cord Stimulator System are followed It is important to read the information in this supplemental manual in its entirety before conducting or recommending an MRI examination on a patient with a Precision Spectra SCS System The ImageReady MRI Guidelines for Precision Spectra Spinal Cord Stimulator System manual appears on the Boston Scientific websites www bostonscientific com an
31. rientation for communication between the Stimulator and the Wand is illustrated below Figure 3 Orientation of External Trial Stimulator and Programming Wand Figure 4 Orientation of Implantable Pulse Generator and Programming Wand Wireless Charging Information Charging Frequency 77 90 kHz The charging distance between the Charger and the IPG is between 0 5 to 2 cm Centering the charger over the stimulator ensures the shortest charging time The Charger will beep as it searches for the IPG and will stop beeping when it is aligned with the IPG Please refer to the instructions provided in the Charging Steps Section of IPG Directions for Use for instructions on aligning the Charger Precision Spectra System Information for Prescribers 91008787 01 RevA 11 of 21 Information for Prescribers Electromagnetic Interference Guidance and Manufacturer s Declaration electromagnetic emissions The Precision Spectra System is intended for use in the electromagnetic environment specified below The customer or user of the Precision Spectra System should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guide RF emissions CISPR 11 Group 1 The Precision Spectra System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class
32. ructions for the Physician Quality of Wireless Service Wireless SOCUIMY nia a a E a E A aA a aE Telemetry ntoimatiOme senas eee aea r a a raa aa aE ea EEEE Electromagnetic Interference Stenlizalio i A ested n a E eee FOC RUGS iiciccicsscacieencwncus teiidedvecauscdeseseniucurdesiududeudedvidadedcoivdcaueceetiusuetanuedenbunrs 16 Technical Service cccccceeeneeeeeeeeseeeseseeeeeeseneeeseeeseseeaeenenneesneeesesseaeennnneesnas 16 End of Programmed Service ccccceceeeeeneeeeeeeeeeseeeeeeeeeeeseesesseeeeeeeeeeseneees 17 IPG Battery Lifer a aa E E N 20 Precision Spectra System Information for Prescribers 91008787 01 Rev A ii of iii Information for Prescribers This page intentionally left blank Precision Spectra System Information for Prescribers 91008787 01 RevA iii of iii Device and Product Description Device and Product Description The Precision Spectra Spinal Cord Stimulator 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 field navigation Thirty two independent current controlled electrodes e Four programmable stimulation areas per prog
33. sted 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 implantation of the device 5 12 patients required repositioning of catheter type electrodes and 2 patients required revision of the stimulator generator Safety Evaluation Eleven studies were identified based on the detailed inclusion exclusion criteria to demonstrate the safety of the Precision Spectra 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 percentage of occurrences of each event compared to the total number of patients It should be noted that citations cover both IPG and RF Systems The clinical experience reported in the literature on RF systems is relevant to determining the safety of totally implantable IPG systems Precision Spectra System Information for Prescribers 91008787 01 RevA 2of21 Precision Spectra System Clinical Summary Table 1 Summary of Risks Identified
34. t the device if the case is damaged Postural Changes Patients should be advised that changes in posture 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 Important If unpleasant sensations occur the IPG should be turned off immediately Electromagnetic Interference Strong electromagnetic fields can potentially turn the Stimulator off or cause uncomfortable or jolting stimulation or affect wireless communication Patients should be counseled to avoid or exercise care around e Theft detectors or security screeners such as those used at entrances exits of department stores libraries and other public establishments and or airport security screening devices It is recommended that patients request assistance to bypass the device If they must proceed through the device the patient should turn off the Stimulator and proceed with caution moving through the center of the screener as quickly as possible Power lines or power generators Electric steel furnaces and arc welders e Large magnetized stereo speakers Tag deactivators such as those found in retail stores and libraries If the patient is near these devices he may become aware of changing stimulation levels In rare instances if the stimulation is on the patient could experience an increase in stimulation lev
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