medtronic bladder stimulator mri safety 3058
5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% 0000000016 00000 n The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000006657 00000 n Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. 0000006231 00000 n 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. 0000009317 00000 n The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. The purpose of the MR safety expert is to minimize risk and optimize scan plans. Healthcare Professionals 0000009782 00000 n 0000010106 00000 n hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> InterStim systems are the standard of care in advanced therapy options . Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. Patients with InterStim SureScan MRI leads only. Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. Methods. 0000018863 00000 n Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. More information (see more) Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. 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. 0000041486 00000 n 0000025529 00000 n Update my browser now. 0000008679 00000 n p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ 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. 0000006184 00000 n 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. 0000027823 00000 n 0000006985 00000 n <> 0 "; 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:"?? 0000023020 00000 n 0000008625 00000 n Br J Surg. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. This site is Exclusively Sponsored by BRACCO. 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. 0000010287 00000 n If you arent, you might as well find a urologist to help you out. trailer 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. 0000018445 00000 n 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 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). Search by model name, product name, or device type. 0000010551 00000 n MRI mode is easy for patients to independently activate or deactivate on the smart programmer. The good news is that many physicians are already familiar with the subject. %%EOF MRI of the hand can be safely carried out with the Medtronic Interstim II device. Copyright 2022 / interstim.net - All rights reserved! Leng WW, Chancellor MB. 0000010169 00000 n 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). With an updated browser, you will have a better Medtronic website experience. 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 . Expiration dates have mostly to do with sterilization and not the integrity of the product. Search for downloadable product manuals by product name or model number. United States Census Bureau Web site. You just clicked a link to go to another website. When the battery is depleted, the neurostimulator must be replaced. See approved labeling for details. "This is not your grandmother's therapy. Questions and Answers in MRI - MRI Questions & Answers; MR imaging . "; 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. Accessed July 19, 2016.5Dmochowski RR, Newman DK. The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. 0000004887 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Recharge-free neurostimulator for bladder and bowel control, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Connects directly to the lead, eliminating need for an extension, Accommodates three lead sizes: 28 cm, 33 cm, and 41 cm, Compatible with a lead insertion indicator in the lead, Incorporates radiopaque identification of manufacturer and model number, Allows full-body MRI scans for patients who need them*, InterStim SureScan MRI lead model 978B1. 0000018245 00000 n He or she works closely with the MR medical director and MR safety officer. Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. 0000006684 00000 n 0000013017 00000 n 2. InterStim II Model 3058 Neurostimulator Table 1. Actual results may differ materially from anticipated results. 0000007625 00000 n De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp [UeK[Xe;vmy65R$yFi 0000018809 00000 n However, several studies have shown no serious adverse outcomes. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. &)k1}Ym@,C#k[q}[n The manufacturers sterilize the products after they are packaged and it lasts so many years. 0000012062 00000 n 0000008924 00000 n 0000009598 00000 n 0000016814 00000 n 0000005584 00000 n ?? Manuals can be viewed using a current version of any major internet browser. 0000008954 00000 n xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J With low energy settings, the device may last up to 15 years. It is important to understand that ferromagnetic metals and metallic implants can be harmful if they move in the flight path of the MR scanner. 446 0 obj <>stream 0000004995 00000 n 2005;32:11-18. This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. 0000027856 00000 n REFERENCE