0000025647 00000 n 0000025529 00000 n 9850 NW 41st Street, Suite 450, Doral, FL 33178 With an updated browser, you will have a better Medtronic website experience. MR safety expert is a person who is responsible for developing a local and safe MR safety framework. InterStim systems are the standard of care in advanced therapy options . 2009;137: 512-517.4United States Quick Facts. startxref Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. It is important to read this information in its entirety before conducting a magnetic resonance imaging (MRI) head scan on a patient with any implanted component of a Medtronic InterStim Therapy neurostimulation system. Methods: Eight MRI examinations at 1.5Tesla were conducted in areas outside the pelvis on six patients with implanted sacral nerve stimulator (InterStim neurostimulator; Medtronic, Inc, Minneapolis, MN, USA). Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. 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. 4.2. 0000004372 00000 n 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. "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. ?? MRI: Testing of the VOCARE Bladder System/Finetech-Brindley Bladder System (Vocare) in a 1.5-Tesla scanner with a maximum spatial gradient of 450 gauss/cm or less, exposed to an average Specific Absorption Rate (SAR) of 1.1 W/kg, for a 30 minute duration resulted in localized temperature rises up to 5.5?C in a gel phantom (without blood flow . InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. 0000014402 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. "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. Current Medical Research and Opinion. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 0000009317 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. Always talk with your doctor about diagnosis and treatment information. 0000009883 00000 n 0 Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. Search for downloadable product manuals by product name or model number. 0000000016 00000 n 0000005392 00000 n <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> JbN}&Kt]FV~Uj_JK p a4! :}\ UxIM#ufX'z4WcHqFtEmXO0Su_[q/]&SZhz19>uK$V4} 1 kG,M^jaRv,gIvO& +x4pU.Vw 33/Ax/M>s["-89@ S$}D l~v626Zr 6o2ulSs?z=^!e/(k&zbxgn-p]o`vl@mv9670>=/o.HU}d~z6X{icp{y X]_ 0000005042 00000 n 0000015308 00000 n %%EOF 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. Gastroenterology. The clinician uses the Clinician app to . Pelvic floor disorders network. 0000006753 00000 n Leng WW, Chancellor MB. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. 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 under the following conditions: - 1.5-Tesla (T) horizontal closed bore - 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) - If possible, do not sedate the patient - Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator off - Eligible Model 3023 Neurostimulators only: Disable the magnet switch Scanning under different conditions may result in severe patient injury or device malfunction. 0000010323 00000 n 0000018707 00000 n The Interstim II device can be safely scanned at 1.5 T. 0000008245 00000 n Patients p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ Less than NBV132955H ? hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp 0000007197 00000 n 0000006023 00000 n It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. Prevalence and burden of overactive bladder in the United States. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. 0000003937 00000 n 0000006657 00000 n Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. The FDA approved the long-lived, rechargeable, full-body MRI compatible Axonics r-SNM System in late 2019, with the first commercial sales occurring in November 2019 . xref If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. %%EOF 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. 0000017228 00000 n 0000023719 00000 n /mBJ-tX/nk}I_.MRs4_ Z@`XJ$ lg~DDL^8!p4-T *\&NTok*^e\zU>ZaSF8"dyJ,rq)9\v67#FQ|FCYH !y+*12p1dbKj)(Ljg7S In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. 0000000016 00000 n This contraindication was due to heating of the electrodes, which could damage neural tissue. MRI, inform the MRI technologist immediately and then contact your doctor. 0000009830 00000 n THE LATEST INFORMATION MAY BE OBTAINED FROM www.medtronic.com/mri MRI and InterStim Therapy It is important to read this information in its entirety before conducting a magnetic resonance imaging (MRI) head scan on a patient with any implanted component of a Medtronic InterStim Therapy neurostimulation system. 0000008679 00000 n HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! 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. The InterStim II Model 3058 Neurostimulator is not rechargeable. If you are a doctor, you should be familiar with MRI safety guidelines. World J Urol. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. 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. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. "; 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:"?? However, it is important to consider the risk posed by your specific MRI scan parameters. Learn how to turn the InterStim neurostimulator on and off with a Interstim iCon programmer.If you've tried other treatments but are still suffering from bla. stream %PDF-1.4 % Manuals can be viewed using a current version of any major internet browser. 0000014184 00000 n Urol Clin North Am. It should be used after you have tried other treatments such as medications and behavioral therapy and they have not worked, or you could not tolerate them. +yLKxN5F`W82r endstream endobj 305 0 obj <>stream "; 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. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. 0000004448 00000 n This site is Exclusively Sponsored by BRACCO. Models: PrimeAdvanced SureScan MRI, Model 97702 RestoreUltra SureScan MRI, Model 91112 RestoreAdvanced SureScan MRI, Model 97713 RestoreSensor SureScan MRI, Model 97714, Neurostimulation System PrimeAdvanced SureScan MRI, Model 97702 Spinal Cord Neurostimulator Spinal Cord Stimulation System PrimeAdvanced SureScan MRI, Model 97702 Medtronic, Inc. www.Medtronic.com Imp, Neurostimulation System PrimeAdvanced SureScan MRI, Model 97702 Spinal Cord Stimulation System Important Note: This device is a full-body eligible system if all specific MRI conditions and device requ, Neurostimulation System RestoreAdvanced SureScan MRI, Model 97713 Spinal Cord Neurostimulator Spinal Cord Stimulation System RestoreAdvanced SureScan MRI, Model 97713 Medtronic, Inc. www.Medtronic.com, Neurostimulation System RestoreAdvanced SureScan MRI, Model 97713 Spinal Cord Stimulation System Important Note: This device is a full-body eligible systemif all specific MRI conditions and device re, Neurostimulation System RestoreSensor SureScan MRI, Model 97714 Spinal Cord Neurostimulator Spinal Cord Stimulation System RestoreSensor SureScan MRI, Model 97714 Medtronic, Inc. www.Medtronic.com Imp, Neurostimulation System RestoreSensor SureScan MRI, Model 97714 Spinal Cord Stimulation System Important Note: This device is a full-body eligible systemif all specific MRI conditions and device requ, Neurostimulation System RestoreUltra SureScan MRI, Model 97712 Spinal Cord Neurostimulator Spinal Cord Stimulation System RestoreUltra SureScan MRI, Model 97712 Medtronic, Inc. www.Medtronic.com Impor, Neurostimulation System RestoreUltra SureScan MRI, Model 97712 Spinal Cord Stimulation System Important Note: This device is a full-body eligible systemif all specific MRI conditions and device requi. 0000008350 00000 n InterStim II Model 3058 Neurostimulator Table 1. 0000009993 00000 n 0000016706 00000 n 1.5T and 3T head coil MRI scans. 0000011240 00000 n However, the safety of MRI of other body regions in InterStim II patients remains uncertain. How sacral nerve stimulation neuromodulation works. In fact, many of them might be considering the InterStim in the near future. The good news is that many physicians are already familiar with the subject. However, if the conditions for safe MRI are ", 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. With an updated browser, you will have a better Medtronic website experience. Exercise caution for patients with heart problems. 2013;100:959968. nmVe:D\YC]R Ab Z Value in Health. 0000025277 00000 n 0000007828 00000 n Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device. 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). 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. The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). 0000016458 00000 n 0000010169 00000 n 0000003363 00000 n Products POR can occur when there is a temporary fluctuation in battery voltage (eg . Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only) Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans: ? December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. 2013;100:959968. Unintended Stimulation MRI may cause unintended stimulation from the implant. trailer 446 0 obj <>stream Sacral Neuromodulation Systems Bladder Control Urol Clin North Am. 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% 0000009089 00000 n More information (see more) Sacral Neuromodulation Systems Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. 0000017570 00000 n See approved labeling for details. Please talk to your doctor to decide whether these therapies are right for you. 0000008298 00000 n About MedtronicBold thinking. Leng WW, Chancellor MB. {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 This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. +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 SureScan MRI leads only. MRI safety guidelines from Medtronic have expanded the range of scan parameters that clinicians can use to provide patients with a comprehensive, reliable, and safe MRI experience. 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." Implanted pulse generators were examined before and after MRI procedures. 0000009782 00000 n 0000007625 00000 n We are Medtronic. 0000010041 00000 n 0000004494 00000 n 0000012610 00000 n Expiration dates have mostly to do with sterilization and not the integrity of the product. 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. 0000018493 00000 n Methods. SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. 0000006985 00000 n Treatments & Therapies Medtronic Bladder Control Therapy delivered by the NURO system treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. 2005;32:1118. Although many patients may benefit from the use of these treatments, results may vary. Fecal incontinence in US adults: epidemiology and risk factors. 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. 0000026803 00000 n The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. endstream endobj 428 0 obj <. 427 20 0000018809 00000 n . 0000011431 00000 n 0000023883 00000 n 2. 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. This manual provides information for use in estimating battery longevity (the number of months or years that the Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. ;zrz'm,E*|3;aB.v` qRy 323 0 obj <>/Filter/FlateDecode/ID[<28836736925E656CEC1D4A45F6B26EFC><9F3AF6A1190447458124BACAF1002E60>]/Index[301 49]/Info 300 0 R/Length 113/Prev 1197727/Root 302 0 R/Size 350/Type/XRef/W[1 3 1]>>stream It is safe and effective. This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 0000006938 00000 n Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. Br J Surg. Hg1}Y@d3}quQ D~+ Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Recharge-free neurostimulator for bladder and bowel control, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, 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, Incorporates radiopaque identification of manufacturer and model number, Allows full-body MRI scans for patients who need them*, InterStim SureScan MRI lead model 978B1. These instructions do not apply to other implantable products, or other devices, products, or items. Historically, patients with implantable SNM devices have been contraindicated for MRI. 0000002333 00000 n &)k1}Ym@,C#k[q}[n In summary, we can say the following about Medtronic InterStim 3058 MRI Safety; MRI of the lumbar and pelvic areas with the InterStim II device can be performed safely, as long as the patient is positioned correctly. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. xref 2009;15(9):728-740. 0000008954 00000 n 0000018055 00000 n 0000012800 00000 n MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Under certain conditions. 0000013358 00000 n Update my browser now. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. That said, you have to ask yourself, are you a patient? Home Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). 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. Interactions with implanted components of the electrodes, which could damage neural tissue already familiar the! About our next chapter in patient-focused therapy innovation % manuals can be viewed using a Version! 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