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Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. View MRI guidelines in the MRI Resource Library.
In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. 0000006753 00000 n
Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com.
United States Census Bureau Web site. 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. Those lucky few will benefit from this devices latest enhancements. This small device will improve patient satisfaction and reduce hospital readmissions. 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. "; 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. SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. Patients 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. With an updated browser, you will have a better Medtronic website experience. The Axonics Sacral Neuromodulation (SNM) System is a sacral nerve stimulation (SNS) system that is intended to treat urinary retention and the symptoms of overactive bladder. 2009;15(9):728-740. 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. 2M
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D3 This site is Exclusively Sponsored by BRACCO. Under certain conditions. 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. Products Leng WW, Chancellor MB. The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. World J Urol. Less than NBV132955H ? "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. He or she also provides advice on non-routine MR procedures. hb```b``^d(31 PCAed a2(m``_XA
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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. %%EOF
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Patients with InterStim MRI Leads only. However, several studies have shown no serious adverse outcomes. 0000014238 00000 n
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Less information (see less).
ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. Update my browser now. Always talk with your doctor about diagnosis and treatment information. 0000007038 00000 n
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The Interstim II device can be safely scanned at 1.5 T. Healthcare Professionals 0000001682 00000 n
- (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! 0000006609 00000 n
NEUROSTIMULATION SYSTEM: INTERSTIM THERAPY SACRAL NERVE STIMULATION (SNS) FOR URINARY CONTROL MRI Guidelines for InterStim Therapy Neurostimulation Systems MR Scanning Conditions MR Conditional: Non-clinical testing has demonstrated that InterStim Therapy systems have been found to be MR Conditional. Implanted pulse generators were examined before and after MRI procedures. Actual results may differ materially from anticipated results. These instructions do not apply to other implantable products, or other devices, products, or items. 0000008679 00000 n
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The clinician uses the Clinician app to . 2013;100:959968. That said, you have to ask yourself, are you a patient? 0000001914 00000 n
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This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. ?? The first and only smart programmer - a programming device that looks like a common smartphone so patients may discreetly and independently adjust their choice of 11 therapy settings at home or on-the-go. How sacral nerve stimulation neuromodulation works. The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. /mBJ-tX/nk}I_.MRs4_ Z@`XJ$
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!y+*12p1dbKj)(Ljg7S Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. 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. MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. 427 0 obj
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There have been few studies evaluating the risk of MRI in patients with this implant. It is possible that some of the products on the other site are not approved in your region or country. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. 0000004995 00000 n
The InterStim II Model 3058 Neurostimulator is not rechargeable. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws.
This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 0000005584 00000 n
Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. However, it is important to consider the risk posed by your specific MRI scan parameters.
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MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000002333 00000 n
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Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region.
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Safety Topic / Subject Article Text 321: Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. Models: PrimeAdvanced SureScan MRI, Model 97702 RestoreUltra SureScan MRI, Model 91112 RestoreAdvanced SureScan MRI, Model 97713 RestoreSensor SureScan MRI, Model 97714. Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). 0000010275 00000 n
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