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. There have been few studies evaluating the risk of MRI in patients with this implant. These therapies are not for everyone. Save my name, email, and website in this browser for the next time I comment. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. With an updated browser, you will have a better Medtronic website experience. 0000008954 00000 n 0000016458 00000 n Search for downloadable product manuals by product name or model number. 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. xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J 0000016706 00000 n Update my browser now. endstream endobj 428 0 obj <. Bladder Control 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). 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. Although many patients may benefit from the use of these treatments, results may vary. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. 0000009830 00000 n 0000016814 00000 n 0000010106 00000 n Healthcare Professionals 0000018809 00000 n Get the details on specific MRI compatibility for neuromodulation therapies. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. ?? Implanted pulse generators were examined before and after MRI procedures. Please talk to your doctor to decide whether these therapies are right for you. ?? }$Y? 0 0000016760 00000 n 0000007430 00000 n 0000028229 00000 n 0000005793 00000 n Regulatory Statements 2. MRI safety guidelines from Medtronic have expanded the range of scan parameters that clinicians can use to provide patients with a comprehensive, reliable, and safe MRI experience. Under certain conditions; see approved labeling for details. 0000004713 00000 n 0000006231 00000 n xref 0000025647 00000 n MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000006609 00000 n Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. How sacral nerve stimulation neuromodulation works. In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, lead (thin wire) movement/migration, device problems, interactions with certain other devices or diagnostic equipment such as MRI, undesirable changes in urinary or bowel function, and uncomfortable stimulation (sometimes described as a jolting or shocking feeling). In August 2020, the FDA approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions. hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp 0000005584 00000 n 2005;32:11-18. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. 0000013358 00000 n Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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). 2009;137: 512-517.4United States Quick Facts. <> . 0000009317 00000 n 0000005392 00000 n 0000018863 00000 n 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. 0000017618 00000 n The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 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. Search for downloadable product manuals by product name or model number. REFERENCE www.medtronic.com/mri. 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. 0000009598 00000 n @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 0000010275 00000 n The purpose of the MR safety expert is to minimize risk and optimize scan plans. Learn the parameters of patient selection for bladder control and bowel control. Central/Eastern Europe, Middle East & Africa, 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 SureScan MRI lead model 978B1. 0000016362 00000 n Implanted pulse generators were examined before and after MRI procedures. 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. 0000017893 00000 n - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control 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. Products 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. /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 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. Of anational survey reduced quality of life because of their symptoms L, fzJTI4 I & p\ }.. Adherence of medications for chronic overactive bladder/urinary incontinence in the area of use is compromised Urol North. B Power-on-reset ( POR ) turns OFF stimulation by resetting the amplitude to 0.0 V all... Inflammation and bleeding near treatment site j { 0000008298 00000 n a ) & | @ a3ix ]! 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