0000008245 00000 n 0000018863 00000 n Class 2 Device Recall InterStim (TM) System. startxref However, it is important to consider the risk posed by your specific MRI scan parameters. SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. Depuy Barrels-Product Line is now a Zimmer Biomet Product, Zimmer Austin-Moore Fenestrated Hip Implants, 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, InterStim smart programmer for clinicians, TYRX neuro absorbable antibacterial envelope, Experience urge incontinence or urgency-frequency, Experience urinary retention without an obstruction, Need another option if medication does not provide symptom relief and/or causes unpleasant side effects, Want an alternative to repeated injections, Have not demonstrated an appropriate response to the InterStim/therapy evaluation, Are unable to operate mobile devices (such as the smart programmer for the InterStim system), Are not appropriate candidates for surgery, Experience retention due to obstructions (such as BPH, cancer, or urethral stricture), Experience urge incontinence and/or passive incontinence, Need another option if medication that does not provide symptom relief and/or causes unpleasant side effects, Have issues using mobile devices (such as the smart programmer for the InterStim system). 0000013460 00000 n startxref 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. . Information on this site should not be used as a substitute for talking with your doctor. endstream endobj 428 0 obj <. Sacral Neuromodulation Systems MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Bolder actions. In everything we do, we are engineering the extraordinary. /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 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. Available at: https://www.census.gov/quickfacts/table/ PST045215/00. MR safety expert is a person who is responsible for developing a local and safe MR safety framework. hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp Bladder Control Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. Under certain conditions; see approved labeling for details. 0000015970 00000 n 0000023686 00000 n HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y 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. These therapies are not for everyone. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. It is possible that some of the products on the other site are not approved in your region or country. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) 0000007197 00000 n 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. For best results, use Adobe Acrobat Reader with the browser. However, several studies have shown no serious adverse outcomes. Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. Ll2@108 by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device. Fecal incontinence in US adults: epidemiology and risk factors. 0000009137 00000 n 0000010106 00000 n This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. 0000018707 00000 n Urol Clin North Am. Healthcare Professionals 0000000696 00000 n 0000010599 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 United States Census Bureau Web site. 0 InterStim II Model 3058 Neurostimulator Table 1. MRI, inform the MRI technologist immediately and then contact your doctor. 0000006023 00000 n Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. 349 0 obj <>stream stream ", "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. 0000004045 00000 n 0000008350 00000 n Eight MRI examinations at 1.5 Tesla were conducted in areas outside the pelvis on six patients with implanted sacral nerve stimulator (InterStim neurostimulator; Medtronic, Inc, Minneapolis, MN, USA). aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. He or she works closely with the MR medical director and MR safety officer. The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). 0000016458 00000 n 756 129 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. 2005;32:11-18. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 0000014136 00000 n 9>sa6 ~Ay@Z/l^/!6pLb+{Mk 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 The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 0000005584 00000 n These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. 0000124808 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. 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). 0000010551 00000 n Methods. MRI-safety expert performed a patients MRI, MRI guidelines expand the range of scan parameters, Kiaraakitty Before Surgery Plastic Surgery, Net Worth. The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. MRI of the hand can be safely carried out with the Medtronic Interstim II device. These instructions do not apply to other implantable products, or other devices, products, or items. 0000005535 00000 n 0000041486 00000 n 0000002333 00000 n 0000009182 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. 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. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 4.2. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. 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 0000011083 00000 n Search by model name, product name, or device type. 0000018809 00000 n 0000028899 00000 n 0000009317 00000 n The latest InterStim is a small, discreet device, making it a safe option for many. 0000012062 00000 n Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. 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. 0000009912 00000 n How sacral nerve stimulation neuromodulation works. 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. 884 0 obj The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. "This is not your grandmother's therapy. The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. 0000005042 00000 n Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. %%EOF 0000016410 00000 n 0000008298 00000 n endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream With an updated browser, you will have a better Medtronic website experience. The first and only smart programmer - a programming device that looks like a common smartphone so patients may discreetly and independently adjust their choice of 11 therapy settings at home or on-the-go. All patients had their parameters recorded; then the IPGs were put to "nominal" status. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. 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. [UeK[Xe;vmy65R$yFi 0000009993 00000 n These components are well depicted on a standard radiograph. Not for human use in the US. 0000012969 00000 n Unintended Stimulation MRI may cause unintended stimulation from the implant. 0000017570 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. 0 0000004887 00000 n 0000006501 00000 n The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000006555 00000 n J Manag Care Pharm. 0000006684 00000 n 0000007795 00000 n hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE 0000012562 00000 n 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 . Manuals can be viewed using a current version of any major internet browser. 0000023177 00000 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. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 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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. The Interstim II device can be safely scanned at 1.5 T. 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). Search for downloadable product manuals by product name or model number. Home 0000007383 00000 n 0000014184 00000 n The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. Those lucky few will benefit from this devices latest enhancements. %PDF-1.4 % However, the safety of MRI of other body regions in InterStim II patients remains uncertain. 0000026803 00000 n 0000016362 00000 n trailer 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. 0000012800 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. The implanted InterStim II system electrically stimulates the sacral nerve, which is thought to normalize neural communication between the bladder and brainand between the bowel and brain.1,2, Medtronic Bladder Control Therapy b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Br J Surg. 0000007625 00000 n InterStim II. 0000006184 00000 n Implanted pulse generators were examined before and after MRI procedures. 0000010287 00000 n %%EOF I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! Historically, patients with implantable SNM devices have been contraindicated for MRI. 0000018197 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. With low energy settings, the device may last up to 15 years. `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. You just clicked a link to go to another website. The InterStim II Model 3058 Neurostimulator is not rechargeable. It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. 0000023020 00000 n Always talk with your doctor about diagnosis and treatment information. 0000016760 00000 n Save my name, email, and website in this browser for the next time I comment. A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . Regulatory Statements 2. 0000010222 00000 n REFERENCE