0000006657 00000 n Impact of overactive bladder on women in the United States: results of anational survey. It is safe and effective. 884 0 obj 0000027445 00000 n 0000008350 00000 n See approved labeling for details. 0000007383 00000 n Medtronic Bladder Control Therapy delivered by the NURO system treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. The only products we caution customers about are ones that are absorbable or drug coated. 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. 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. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 2. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. 349 0 obj <>stream InterStim systems are the standard of care in advanced therapy options . 0000018755 00000 n 0000003937 00000 n Home 0000005392 00000 n 0000009645 00000 n 446 0 obj <>stream 0000006753 00000 n 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. 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. 0000014184 00000 n This manual provides information for use in estimating battery longevity (the number of months or years that the 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 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 This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. 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. Save my name, email, and website in this browser for the next time I comment. 0000027856 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). Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. 301 0 obj <> endobj 0000006985 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 0000016760 00000 n (8^T?Z$$0r 0000012969 00000 n 0000008245 00000 n Urol Clin North Am. 0000005225 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. 0000005583 00000 n 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. }$Y? 0000018959 00000 n Healthcare Professionals 0000026803 00000 n Always talk with your doctor about diagnosis and treatment information. 0000016362 00000 n 0000013358 00000 n Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. The latest InterStim is a small, discreet device, making it a safe option for many. +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. If you continue, you may go to a site run by someone else. 0000009182 00000 n Products 0000010323 00000 n These instructions do not apply to other implantable products, or other devices, products, or items. 0000009993 00000 n December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. 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. 0000009912 00000 n 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 0000008298 00000 n However, if the conditions for safe MRI are 0000009883 00000 n 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 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. Patients with InterStim SureScan MRI leads only. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. 0000012610 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. He or she works closely with the MR medical director and MR safety officer. 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. 0000009089 00000 n Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. With an updated browser, you will have a better Medtronic website experience. 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. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 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). 0000018445 00000 n 0000009782 00000 n However, it is important to consider the risk posed by your specific MRI scan parameters. 756 129 0000008924 00000 n InterStim II. InterStim Therapy for Urinary Control (Medtronic, Inc., Minneapolis, MN), Neurostimulation System, Non-clinical testing has demonstrated that InterStim Therapy, systems have been found to be MR Conditional. 0000006231 00000 n hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE 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. REFERENCE