You must demonstrate an appropriate response to the evaluation to be a candidate.
1.5T and 3T head coil MRI scans. 0000015970 00000 n
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This therapy is not intended for patients with a urinary blockage.
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The new Medtronic scanning parameters 1 increases SAR limits for 1.5 Tesla scans from 0.5 W/kg to 2.0 W/kg; and for 3 Tesla scans from 0.5 W/kg to 1.4 W/kg. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must.
Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. Home I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! 0000016706 00000 n
?? "Countless people suffer from symptoms of bladder and bowel control conditions and thanks to significant recent technology advancements, SNM therapy is becoming a more popular option for patients," said Jannah H. Thompson, M.D., FPMRS, president of the Society of Women in Urology, and urologist at Urologic Consultants in Grand Rapids, Michigan. &)k1}Ym@,C#k[q}[n Healthcare Professionals b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5
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This manual provides information for use in estimating battery longevity (the number of months or years that the Actual results may differ materially from anticipated results. Urological 0000009830 00000 n
Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. 0000012014 00000 n
Get the details on specific MRI compatibility for neuromodulation therapies. Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. Home 0000001682 00000 n
Products More information (see more) 0000000016 00000 n
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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. 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: JbN}&Kt]FV~Uj_JK
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X]_ This site is Exclusively Sponsored by BRACCO. "; 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:Cambria; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1073743103 0 0 415 0;} @font-face {font-family:ArialMT; panose-1:0 0 0 0 0 0 0 0 0 0; mso-font-alt:Arial; mso-font-charset:77; mso-generic-font-family:swiss; mso-font-format:other; mso-font-pitch:auto; mso-font-signature:3 0 0 0 1 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:10.0pt; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"?? He or she works closely with the MR medical director and MR safety officer. 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. 0000019081 00000 n
MR safety expert is a person who is responsible for developing a local and safe MR safety framework. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000017618 00000 n
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However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. 0000016018 00000 n
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The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Current Medical Research and Opinion. With low energy settings, the device may last up to 15 years. 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. trailer
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. Although many patients may benefit from the use of these treatments, results may vary. 0000000016 00000 n
We are Medtronic. 0000009317 00000 n
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InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy.
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There have been few studies evaluating the risk of MRI in patients with this implant. How sacral nerve stimulation neuromodulation works. 0000011192 00000 n
The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. endstream
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However, it is important to consider the risk posed by your specific MRI scan parameters. The good news is that many physicians are already familiar with the subject. Accessed July 19, 2016.5Dmochowski RR, Newman DK. 0000016458 00000 n
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Patients with InterStim MRI Leads only. 0000004467 00000 n
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Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. Expiration dates have mostly to do with sterilization and not the integrity of the product. 0000023451 00000 n
Urol Clin North Am. 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). These therapies are not for everyone.
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The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStimu001d neurostimulators for sacral neuromodulation therapy. {eH3zAsW[@9]E.}(ku4}0g{QsyzIOurFvDlM/6H7h*0ZZ5wp8'J={Z6yWkitXLq}l~Ke*Ra{6W"%{.N" %]B&m}AO_=
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These treatments are prescribed by your doctor.
Under certain conditions; see approved labeling for details. MRI, inform the MRI technologist immediately and then contact your doctor. These updates also allow for a shorter waiting time between MRI scans. United States Census Bureau Web site. ;zrz'm,E*|3;aB.v` qRy
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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. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. 0000006938 00000 n
The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. Sacral Neuromodulation Systems 0000008003 00000 n
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<. The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. <<643BDC4F02F463BA264A9A2366C35000>]>>
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The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions.
neurostimulator will provide stimulation at programmed settings before requiring recharge). <>
The purpose of the MR safety expert is to minimize risk and optimize scan plans. 9850 NW 41st Street, Suite 450, Doral, FL 33178 If you continue, you may go to a site run by someone else. 0000025647 00000 n
MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 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). 0000018197 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. Search for downloadable product manuals by product name or model number.
Gastroenterology.
If you are a doctor, you should be familiar with MRI safety guidelines. In everything we do, we are engineering the extraordinary. 0000018755 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). However, the safety of MRI of other body regions in InterStim II patients remains uncertain.
The Medtronic InterStim II Model 3058 Neurostimulator is used with a lead and the Medtronic InterStim Model 3023 Neurostimulator is used with a lead and an .
MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Available at: https://www.census.gov/quickfacts/table/ PST045215/00. 0000009137 00000 n
For best results, use Adobe Acrobat Reader with the browser. These components are well depicted on a standard radiograph. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000065437 00000 n
Patients with InterStim SureScan MRI leads only.
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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. 0000007625 00000 n
Search for downloadable product manuals by product name or model number. 0000025529 00000 n
In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. 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). 756 0 obj
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However, several studies have shown no serious adverse outcomes. 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. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 0000001914 00000 n
De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). Prevalence and burden of overactive bladder in the United States. 9>sa6 ~Ay@Z/l^/!6pLb+{Mk 0000007197 00000 n
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REFERENCE