0000065437 00000 n %PDF-1.5 % Less information (see less). Do not use if the skin in the area of use is compromised. The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). 0000012617 00000 n hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> Urological View MRI guidelines in the MRI Resource Library. 0000013017 00000 n 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: ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. 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. 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. 0000004372 00000 n 0000002263 00000 n If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. Implanted pulse generators were examined before and after MRI procedures. Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. The only products we caution customers about are ones that are absorbable or drug coated. 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. He or she works closely with the MR medical director and MR safety officer. trailer startxref 0000028899 00000 n 0000004995 00000 n Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans. 2013;100:959968. This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. 0000018707 00000 n Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. All patients had their parameters recorded; then the IPGs were put to "nominal" status. %PDF-1.3 % 0000018911 00000 n Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. Manuals can be viewed using a current version of any major internet browser. 0000006938 00000 n Implanted pulse generators were examined before and after MRI procedures. 0000008298 00000 n 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. I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 0000009993 00000 n (8^T?Z$$0r A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . The manufacturers sterilize the products after they are packaged and it lasts so many years. +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. 0000019081 00000 n 2009;137: 512-517.4United States Quick Facts. Home 0000004448 00000 n 0000018055 00000 n 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. 0000014674 00000 n ?? 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 . Search by model name, product name, or device type. InterStim II. In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. 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. 0000005225 00000 n @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 Those lucky few will benefit from this devices latest enhancements. In everything we do, we are engineering the extraordinary. 0000023883 00000 n That said, you have to ask yourself, are you a patient? The implanted InterStim II system electrically stimulates the sacral nerve, which is thought to normalize neural communication between the bladder and brainand between the bowel and brain.1,2, Medtronic Bladder Control Therapy "; mso-font-charset:78; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1791491579 18 0 131231 0;} @font-face {font-family:"?? 0000023451 00000 n 0000014136 00000 n Current Medical Research and Opinion. This manual provides information for use in estimating battery longevity (the number of months or years that the Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. 0000017893 00000 n 0000017570 00000 n These treatments are prescribed by your doctor. The new Medtronic scanning parameters 1 increases SAR limits for 1.5 Tesla scans from 0.5 W/kg to 2.0 W/kg; and for 3 Tesla scans from 0.5 W/kg to 1.4 W/kg. You may choose to re-enter your serial number, or contact Medtronic at one of the numbers below: Information for Healthcare Providers US Technical Services Department. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. Bladder Control Search for downloadable product manuals by product name or model number. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. j 0000007038 00000 n 2. Methods. 0000010599 00000 n 0000010169 00000 n xref The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. 427 0 obj <> endobj Products 0 Expiration dates have mostly to do with sterilization and not the integrity of the product. aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h 0000024733 00000 n REFERENCE