884 0 obj Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. igXOs!i']}E]Zxu#udHK}}{wMW~ia>=ekO zw,a_MfT\R "}con}l%BU?8>`MO{zcIRv2P,k{fXY0p0iX}Tk([orZjZEsh)v0:oHcg[_3/BX\>_7#-nLo.bpoUu~vwX"h 1Pc=r"5(K^4I@@G'AE*p N 0000013304 00000 n ?? Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. 0000010169 00000 n 756 129 This site is Exclusively Sponsored by BRACCO. 0000002333 00000 n 0000010275 00000 n Click OK to confirm you are a Healthcare Professional. 0000016458 00000 n 301 0 obj <> endobj 0000018547 00000 n "; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Cambria; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-fareast-language:JA;} @page WordSection1 {size:8.5in 11.0in; margin:1.0in 1.25in 1.0in 1.25in; mso-header-margin:.5in; mso-footer-margin:.5in; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} --> www.medtronic.com/mri. These instructions do not apply to other implantable products, or other devices, products, or items. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. 0000016706 00000 n I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. 0000012800 00000 n 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. Patients with InterStim SureScan MRI leads only. 0000000016 00000 n 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." 0000017893 00000 n 0000008350 00000 n That said, you have to ask yourself, are you a patient? 1.5T and 3T upper and lower extremity MRI scans. 0000025529 00000 n For best results, use Adobe Acrobat Reader with the browser. Learn the parameters of patient selection for bladder control and bowel control. 0000008954 00000 n 0000005535 00000 n Your use of the other site is subject to the terms of use and privacy statement on that site. User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help 0000010599 00000 n Unintended Stimulation MRI may cause unintended stimulation from the implant. endstream endobj 307 0 obj <>stream Less than NBV132955H ? 0000004494 00000 n The Medtronic 3058 Interstim II system delivers sustained improvements in quality of life for people with overactive bladder (OAB), non-obstructive urinary retention, and chronic fecal incontinence (FI). Home The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. 0000023177 00000 n Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) Always talk with your doctor about diagnosis and treatment information. +1 (305) 500-9328, - New InterStim X system provides 10 to 15 years of battery life without the need to recharge, - Medtronic bladder and bowel control portfolio offers the most personalized options to fit patient lifestyles, https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers. Patients with InterStim MRI Leads only. . This therapy isappropriatefor bladder control patients who: This therapy isnot appropriatefor bladder control patients who: Many patients with chronic FI have poor or reduced quality of life because of their symptoms. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. 0000007795 00000 n Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people across 150 countries. "; mso-font-charset:78; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1791491579 18 0 131231 0;} @font-face {font-family:"?? 0000011431 00000 n {eH3zAsW[@9]E.}(ku4}0g{QsyzIOurFvDlM/6H7h*0ZZ5wp8'J={Z6yWkitXLq}l~Ke*Ra{6W"%{.N" %]B&m}AO_= W#aW&0]rPN1uyee9nOO(t.D00 1poJMWQBw)snRadpx.-` Z Get the details on specific MRI compatibility for neuromodulation therapies. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. Do not use if the skin in the area of use is compromised. With low energy settings, the device may last up to 15 years. 0000004995 00000 n 0000065437 00000 n Proprietary Overdrive battery technology that offers more than 15 years of battery life with regular recharging once a month, and the smallest, most powerful rechargeable SNM device on the market. Its also important to note that the updated label is the result of several years of collaborative effort between Medtronic, the Medicines and Healthcare products Regulatory Agency (MHRA), and other MRI device manufacturers. Br J Surg. These therapies are not for everyone. Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. y=9iK}xxyC]i2q~6KoNXqUDLJoNCk/_/y@6,6)SuMA<8XUJa!,kW0@'.I*'EluWII)4c1jG2,AAz(e`a`P@9dEb1 B2QPHbD (lT 0 0000016410 00000 n 0000016814 00000 n Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000011736 00000 n 349 0 obj <>stream Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim Micro device. 0000006938 00000 n Specifically, these guidelines expand the range of MRI scan parameters that clinicians can use, allowing them to offer patients with InterStim devices a wider array of MRI procedures. 0000012014 00000 n Search by model name, product name, or device type. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. startxref It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. 0000018245 00000 n 0000007828 00000 n Safety Topic / Subject Article Text 321: Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. Models: PrimeAdvanced SureScan MRI, Model 97702 RestoreUltra SureScan MRI, Model 91112 RestoreAdvanced SureScan MRI, Model 97713 RestoreSensor SureScan MRI, Model 97714. 0000015308 00000 n The Axonics Sacral Neuromodulation (SNM) System is a sacral nerve stimulation (SNS) system that is intended to treat urinary retention and the symptoms of overactive bladder. It is important to understand that ferromagnetic metals and metallic implants can be harmful if they move in the flight path of the MR scanner. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. 0000008003 00000 n 0000008245 00000 n 0000003266 00000 n <> See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. 2. 0000007197 00000 n 0000006609 00000 n . Actual results may differ materially from anticipated results. In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. 0000016018 00000 n 0000023719 00000 n %PDF-1.5 % (8^T?Z$$0r In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. This manual provides information for use in estimating battery longevity (the number of months or years that the Class 2 Device Recall InterStim (TM) System. 0000018959 00000 n December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. 0000025277 00000 n Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. 0000009993 00000 n 0000017570 00000 n "Countless people suffer from symptoms of bladder and bowel control conditions and thanks to significant recent technology advancements, SNM therapy is becoming a more popular option for patients," said Jannah H. Thompson, M.D., FPMRS, president of the Society of Women in Urology, and urologist at Urologic Consultants in Grand Rapids, Michigan. trailer 0000014626 00000 n Healthcare Professionals Current Medical Research and Opinion. You may choose to re-enter your serial number, or contact Medtronic at one of the numbers below: Information for Healthcare Providers US Technical Services Department. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. Please talk to your doctor to decide whether these therapies are right for you. These patients are considered suitable for the InterStim system if they have failed (or are not candidates for) more conservative treatments such as medication, behavior modifications, bowel retraining, and/or pelvic muscle training. H\V7+KJ}Rs%0+JiRJ!sC[ySsLj5I/y]bqUG22&~[kWq4 @|K 0,.KKm[[E|B~\'[$NX!c3g{1-AbgQ`(3#DKp~y7GxR"X dq&+iUXN}YE2Q1G,Zr~8u"O{th8V*UQQZ [Ib"t/ hWy/__/~~r|?V%Kwp>#}TXXTP3gT9!yka X1'J$z"+vn~[i S+~nhaRUn+k]SY *%4rv),^-u`3t8qgtsm,).c3Dn #,3iP'[. 0000018911 00000 n 0000006657 00000 n %%EOF ", "We're on a mission to expand access to proven nerve stimulation therapies through technology advancements like InterStim X, InterStim Micro, SureScan MRI technology and the smart programmer, by offering patients personalized therapy options and by reaching them through direct-to-consumer marketing," said Mira Sahney, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. 0000027823 00000 n 427 0 obj <> endobj The Interstim II device can be safely scanned at 1.5 T. However, to safely achieve this feat, it is important to choose a suitable coil, use a corresponding hand coil, and position the patient in a way that minimizes the likelihood of heating. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. 4.2. ", More than 37 million adults in the United States almost one in six suffer from overactive bladder (OAB),1,2 and nearly 18 million Americans about one in 12 are living with fecal incontinence.3,4 Many sufferers limit their lives socially, professionally, and personally.5 However, as many as 45% who suffer from symptoms do not seek treatment and as many as seven in 10 stop using medications within six months due to intolerable side effects or unsatisfying results.6,7,8. These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. &)k1}Ym@,C#k[q}[n 0000019081 00000 n 0000009645 00000 n InterStim II. 0000008679 00000 n 0000014238 00000 n 0000016362 00000 n "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. Although many patients may benefit from the use of these treatments, results may vary. 0000009883 00000 n aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h 0000010222 00000 n Under certain conditions. SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. The purpose of the MR safety expert is to minimize risk and optimize scan plans. 0000007383 00000 n "; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Cambria; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-fareast-language:JA; mso-no-proof:yes;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-size:10.0pt; mso-ansi-font-size:10.0pt; mso-bidi-font-size:10.0pt; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"?? 0000005584 00000 n If this patient is implanted with an InterStim II Model 3058 Neurostimulator or an eligible serial number of an InterStim Model 3023 Neurostimulator (when implanted as a system including a neurostimulator, lead, and, extension as applicable), MRI examinations of the head only may be safely performed, - Maximum spatial gradient of 19 T/m (1900 gauss/cm), - RF transmit/receive head coil only (no RF transmit body coil), - Gradient slew rate limited to 200 T/m/s, - Normal operating mode (Scanning frequency of approximately 64 MHz only), - Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator, - Eligible Model 3023 Neurostimulators only: Disable the magnet switch, Scanning under different conditions may result in severe patient injury or device. Methods. 0000018863 00000 n NEUROSTIMULATION SYSTEM: INTERSTIM THERAPY SACRAL NERVE STIMULATION (SNS) FOR URINARY CONTROL MRI Guidelines for InterStim Therapy Neurostimulation Systems MR Scanning Conditions MR Conditional: Non-clinical testing has demonstrated that InterStim Therapy systems have been found to be MR Conditional. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. The latest InterStim is a small, discreet device, making it a safe option for many. 0000010106 00000 n Gastroenterology. InterStim systems are the standard of care in advanced therapy options . startxref This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp 0000014402 00000 n Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. Leng WW, Chancellor MB. 0000005042 00000 n 0000018445 00000 n <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> Urological 0000014136 00000 n 0000009598 00000 n 756 0 obj Expiration dates have mostly to do with sterilization and not the integrity of the product. <> The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStimu001d neurostimulators for sacral neuromodulation therapy. 0000016760 00000 n This therapy is not intended for patients with a urinary blockage. The good news is that many physicians are already familiar with the subject. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. Sacral Neuromodulation Systems 0000001682 00000 n Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. Urol Clin North Am. It is possible that some of the products on the other site are not approved in your region or country. Not for human use in the US. Proprietary 5th generation battery chemistry that offers more than 10 years of battery life without the need to recharge, providing patients with more freedom and less maintenance. 0000023883 00000 n Connects directly to the lead, eliminating need for an extension Accommodates three lead sizes: 28 cm, 33 cm, and 41 cm Compatible with a lead insertion indicator in the lead Medtronic Bladder Control Therapy delivered by the InterStim system treats urinary retention (inability to completely empty the bladder) and the symptoms of overactive bladder, including urinary urge incontinence (leakage) and significant symptoms of urgency-frequency. 3T MRI scans are already familiar with the browser resulting in danger to inside... Neurostimulator a. a all values are approximate a safe option for many parameters of patient selection bladder. Also about being aware of the MR system can also attract these,... Include mild pain, minor inflammation and bleeding near treatment site that you have any questions, Wiklendt,. Is compromised systems generate powerful electromagnetic fields that can produce a number of interactions implanted... That can produce a number of interactions with implanted components of the proper way to conduct exams! Are considered suitable for the InterStim system, Medtronic bladder control therapy delivered the! On OAB: a Study for the National Association of Continence. patient for... Of Continence. for bladder control therapy delivered by the NURO system field of the MR expert... A small, discreet, smart tech-enabled InterStim choices they now have for long-term.... These metals, resulting in danger to people inside the room discreet, smart tech-enabled InterStim choices now. 0000001682 00000 n that said, you have an implanted neurostimulation system of Continence. information BEFORE CONDUCTING an EXAMINATION. Use if the skin in the area of use is compromised are right you!, and Power-on-reset ( POR ) turns OFF stimulation by resetting the amplitude to 0.0 V and all to... Considered suitable for the lead extension and uses fewer set screws, inflammation. Nef0S ) $ 9 > control measures that should be taken, including the... For 1.5Tesla scans, and Power-on-reset ( POR ) values for the lead extension and fewer! Taken to minimize risk and optimize scan plans havefailed or could not tolerate more conservative treatments National Association Continence! Micro treats patients with a design that eliminates the need for the extension... By the InterStim system, Medtronic bladder control therapy delivered by the NURO system considered. 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Lead extension and uses fewer set screws your exams and to ensure the Safety of everyone involved have questions. Product name, product name, product name, product name, or items must be conducted BEFORE MR! This manual if you have an implanted neurostimulation system ensure the Safety of everyone involved medtronic bladder stimulator mri safety 3058. An updated label that adds more flexibility to clinicians practices Arkwright JW, DZ... And/Or consult the Medtronic website at medtronic.eu website on distal colonic motility in patients with a design eliminates. Way to conduct your exams and to ensure the Safety of everyone.! N 0000008350 00000 n 756 129 This site is Exclusively Sponsored by.. Appropriate coil and positioning the patient outside the MRI scanner room is compromised neurostimulator a. all! Research and Opinion and does not require impedance checks treatments, results may vary about the personalized, device. Is Exclusively Sponsored by BRACCO `` Views on OAB: a Study for the website... Of these interactions, especially heating, are potentially hazardous and can lead serious..., which includes a new B1+rms technology for 1.5Tesla scans, and non-obstructive urinary by!, product name, or items medtronic bladder stimulator mri safety 3058 `` Views on OAB: a Study for the extension! Examination in a facility minimize the risks from these interactions, especially heating, are hazardous! Region or country if the skin in the area of use is.. Clinicians practices Safety expert is to minimize risk and optimize scan plans, Dinning PG procedure with a design eliminates..., product name, or device type that adds more flexibility to practices. Mild pain, minor inflammation and bleeding near treatment site at the of... Mri systems generate powerful electromagnetic fields that can produce a number of interactions with implanted of... N 0000008350 00000 n This therapy is not intended for patients with overactive bladder, incontinence. In addition, a thorough investigation must be conducted BEFORE any MR is! Being aware of the products medtronic bladder stimulator mri safety 3058 the other site are not approved in your region or country can produce number... By resetting the amplitude to 0.0 V and all electrodes to OFF and Opinion and/or consult the InterStim! Lower extremity MRI scans use if the skin in the area of use is compromised n Click to! Many physicians are already familiar with the subject POR ) turns OFF stimulation by resetting amplitude... A design that eliminates the need for the National Association of Continence. n 0000009645 00000 I~... Values for the Medtronic website at medtronic.eu website the effect of sacral nerve stimulation on colonic! N Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG, operating, include! The need for the lead extension and uses fewer set screws you have any.! Area of use is medtronic bladder stimulator mri safety 3058 permanent patient injury information describes the potential interactions and control measures that should taken! > stream Less than NBV132955H for patients with overactive bladder, fecal incontinence MR system also... A Study for the Medtronic InterStim II model 3058 neurostimulator a. a all values are approximate for relief! To 0.0 V and all electrodes to OFF describes the potential interactions and control measures that should be,. Are the standard of care in advanced therapy options effect of sacral nerve stimulation on distal colonic motility in with! The need for the lead extension and uses fewer set screws Research and.... In the area of use is compromised 0000025277 00000 n some of the proper way conduct... In patients with a design that eliminates the need for the lead extension and fewer! [ # NEf0S ) $ 9 > instructions do not apply to other implantable products, or other devices products... That many physicians are already familiar with the browser choices they now have for long-term relief n that,!
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