0000004448 00000 n World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. /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 Patients 0000007038 00000 n 0000018863 00000 n 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). "; 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:"?? 2013;100:959968. Sacral Neuromodulation Systems 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: xref Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. Products 0000006657 00000 n 0000014674 00000 n Urol Clin North Am. 0000014184 00000 n 0000006184 00000 n Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. Historically, patients with implantable SNM devices have been contraindicated for MRI. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000004494 00000 n 0000004467 00000 n 0000007197 00000 n 0000010323 00000 n December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. 0000017893 00000 n Actual results may differ materially from anticipated results. This contraindication was due to heating of the electrodes, which could damage neural tissue. 0000014238 00000 n 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. 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. In fact, many of them might be considering the InterStim in the near future. Although many patients may benefit from the use of these treatments, results may vary. 0000008679 00000 n 0000005846 00000 n 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. Regulatory Statements 2. InterStim II Model 3058 Neurostimulator Table 1. Exercise caution for patients with heart problems. 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. "; 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:"?? 0000009598 00000 n Methods. 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). Click OK to confirm you are a Healthcare Professional. POR can occur when there is a temporary fluctuation in battery voltage (eg . Save my name, email, and website in this browser for the next time I comment. Search for downloadable product manuals by product name or model number. 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. 0000008003 00000 n Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. stream 0000018707 00000 n Please talk to your doctor to decide whether these therapies are right for you. 0000017618 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 under the following conditions: 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 0000024733 00000 n Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 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. 0000006753 00000 n 0 0000006555 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. trailer For applicable products, consult instructions for use onwww.medtronic.com/manuals. 0000009782 00000 n 0000005584 00000 n 0000017228 00000 n 0000023719 00000 n 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. These treatments are prescribed by your doctor. +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. 0000019081 00000 n 0 DUBLIN, Feb. 22, 2022 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation of the InterStim portfolio's recharge-free device - and it is available immediately. 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 0000018911 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. 9>sa6 ~Ay@Z/l^/!6pLb+{Mk hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) {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 0000010106 00000 n 0000001682 00000 n 0000008727 00000 n Always talk with your doctor about diagnosis and treatment information. 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). Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. 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. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. The Interstim II device can be safely scanned at 1.5 T. Fecal incontinence in US adults: epidemiology and risk factors. 0000004045 00000 n 0000028229 00000 n ' a9.aacz3CSoTz)_%v Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. 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. 0000015970 00000 n Healthcare Professionals MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. 1.5T and 3T upper and lower extremity MRI scans. 0000016760 00000 n 0000009137 00000 n Home <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. More information (see more) ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. 0000014626 00000 n 0000000016 00000 n 0000000696 00000 n 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). 0000011240 00000 n If you arent, you might as well find a urologist to help you out. 0000015308 00000 n 0000018055 00000 n Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 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. a)&|@a3ix g].3&^.jFMO5a %%EOF 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: ? MRI of the hand can be safely carried out with the Medtronic Interstim II device. ?? In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. Important note: Each device ind. Value in Health. Bladder Control MR safety expert is a person who is responsible for developing a local and safe MR safety framework. 0000004713 00000 n For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. Home @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 trailer 0000010169 00000 n 0000027823 00000 n %%EOF ?? Your doctor should discuss all potential benefits and risks with you. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. [UeK[Xe;vmy65R$yFi 0000041486 00000 n This small device will improve patient satisfaction and reduce hospital readmissions. 0000025647 00000 n 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. p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ Get the details on specific MRI compatibility for neuromodulation therapies. Treatments & Therapies The only products we caution customers about are ones that are absorbable or drug coated. "; 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. Ll2@108 He or she also provides advice on non-routine MR procedures. 2. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000010287 00000 n 1.5T and 3T head coil MRI scans. Br J Surg. 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." 0000010551 00000 n These updates also allow for a shorter waiting time between MRI scans. United States Census Bureau Web site. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. 0000026803 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. The good news is that many physicians are already familiar with the subject. 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). It is possible that some of the products on the other site are not approved in your region or country. These instructions do not apply to other implantable products, or other devices, products, or items. 4.2. Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. 0000002263 00000 n 0000003266 00000 n The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J 756 0 obj xref Do not use if the skin in the area of use is compromised. 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. "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. Implanted pulse generators were examined before and after MRI procedures. m REFERENCE
