Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control.
He or she works closely with the MR medical director and MR safety officer. MRI, inform the MRI technologist immediately and then contact your doctor. Please talk to your doctor to decide whether these therapies are right for you. 0000018755 00000 n
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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. This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images.
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<. Historically, patients with implantable SNM devices have been contraindicated for MRI. This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. stream
In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. Its also important to note that the updated label is the result of several years of collaborative effort between Medtronic, the Medicines and Healthcare products Regulatory Agency (MHRA), and other MRI device manufacturers. See approved labeling for details. Patients The purpose of the MR safety expert is to minimize risk and optimize scan plans. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn.
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Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000003266 00000 n
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THE LATEST INFORMATION MAY BE OBTAINED FROM www.medtronic.com/mri MRI and InterStim Therapy 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.
This small device will improve patient satisfaction and reduce hospital readmissions. Unintended Stimulation MRI may cause unintended stimulation from the implant. Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. 0000009182 00000 n
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Implanted pulse generators were examined before and after MRI procedures. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 0000027823 00000 n
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. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. The Interstim II device can be safely scanned at 1.5 T. +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. <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>>
Expiration dates have mostly to do with sterilization and not the integrity of the product. Although many patients may benefit from the use of these treatments, results may vary.
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The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. Implanted pulse generators were examined before and after MRI procedures. /mBJ-tX/nk}I_.MRs4_ Z@`XJ$
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P&Dg*[@K6WrqFKe]3 Medtronic Bladder Control Therapy delivered by the InterStim system treats urinary retention (inability to completely empty the bladder) and the symptoms of overactive bladder, including urinary urge incontinence (leakage) and significant symptoms of urgency-frequency. hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y
[> With low energy settings, the device may last up to 15 years. United States Census Bureau Web site. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000006231 00000 n
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Important note: Each device ind. Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000009830 00000 n
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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. Ll2@108 endstream
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Pelvic floor disorders network. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. 0000009645 00000 n
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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
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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. Leng WW, Chancellor MB. With an updated browser, you will have a better Medtronic website experience. Less than NBV132955H ? Bladder Control That said, you have to ask yourself, are you a patient? 0000015970 00000 n
ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. endstream
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The Interstim II device can be safely scanned at 1.5 T. However, to safely achieve this feat, it is important to choose a suitable coil, use a corresponding hand coil, and position the patient in a way that minimizes the likelihood of heating. endstream
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Class 2 Device Recall InterStim (TM) System. This therapy is not intended for patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function, or on patients who are pregnant or planning pregnancy. neurostimulator will provide stimulation at programmed settings before requiring recharge). 0000008051 00000 n
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. 0000007383 00000 n
Patients with InterStim SureScan MRI leads only. More information (see more) 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. <>
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. You just clicked a link to go to another website. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. 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.
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For best results, use Adobe Acrobat Reader with the browser. In August 2020, the FDA approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions. 0000027856 00000 n
These treatments are prescribed by your doctor.
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It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. 0000006684 00000 n
?? REFERENCE www.medtronic.com/mri. 0000005793 00000 n
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?? Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy.
"As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. 0000018055 00000 n
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This contraindication was due to heating of the electrodes, which could damage neural tissue. 0000007828 00000 n
MRI mode is easy for patients to independently activate or deactivate on the smart programmer. 0000018493 00000 n
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If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. 0000008625 00000 n
Your doctor should discuss all potential benefits and risks with you. Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans.
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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. Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. %PDF-1.5
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Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000009089 00000 n
MR safety expert is a person who is responsible for developing a local and safe MR safety framework.
You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. You must demonstrate an appropriate response to the evaluation to be a candidate. Available at: https://www.census.gov/quickfacts/table/ PST045215/00. 0000025647 00000 n
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.
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This therapy is not intended for patients with a urinary blockage. 0000006555 00000 n
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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). 0000004372 00000 n
Actual results may differ materially from anticipated results. Urological 2005;32:11-18. World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. 0000008298 00000 n
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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. However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. 0000004713 00000 n
+yLKxN5F`W82r Gastroenterology. Home Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy.
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 0000011527 00000 n
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.
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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). In fact, many of them might be considering the InterStim in the near future. 2M
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1.5T and 3T head coil MRI scans. Get the details on specific MRI compatibility for neuromodulation therapies. All patients had their parameters recorded; then the IPGs were put to "nominal" status. 0000013358 00000 n
The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. Patients with InterStim MRI Leads only.
a)&|@a3ix g].3&^.jFMO5a It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. 4.2. Medtronic Bladder Control Therapy delivered by the NURO system treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. 0000008397 00000 n
Under certain conditions; see approved labeling for details. World J Urol. xref
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Less information (see less).
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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. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000000016 00000 n
Search for downloadable product manuals by product name or model number.
The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic Many patients with OAB or retention have poor or reduced quality of life because of their symptoms.
Urol Clin North Am. 0000009912 00000 n
Depuy Barrels-Product Line is now a Zimmer Biomet Product, Zimmer Austin-Moore Fenestrated Hip Implants, 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 smart programmer for clinicians, TYRX neuro absorbable antibacterial envelope, Experience urge incontinence or urgency-frequency, Experience urinary retention without an obstruction, Need another option if medication does not provide symptom relief and/or causes unpleasant side effects, Want an alternative to repeated injections, Have not demonstrated an appropriate response to the InterStim/therapy evaluation, Are unable to operate mobile devices (such as the smart programmer for the InterStim system), Are not appropriate candidates for surgery, Experience retention due to obstructions (such as BPH, cancer, or urethral stricture), Experience urge incontinence and/or passive incontinence, Need another option if medication that does not provide symptom relief and/or causes unpleasant side effects, Have issues using mobile devices (such as the smart programmer for the InterStim system). This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. [UeK[Xe;vmy65R$yFi Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). Leng WW, Chancellor MB. It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. Proprietary 5th generation battery chemistry that offers more than 10 years of battery life without the need to recharge, providing patients with more freedom and less maintenance.
Under certain conditions. 0000014184 00000 n
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. 0000010106 00000 n
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Less information (see less). 0000016760 00000 n
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When the battery is depleted, the neurostimulator must be replaced. 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 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. 0000006938 00000 n
0000006231 00000 n if using an MRI lucky few will benefit from devices. Lead extension and uses fewer set screws MRI leads only from anticipated results [ =Wbx7TJCvSVvjiTB.|Ug ~w|. A candidate in patient-focused therapy innovation colonic motility in patients with InterStim SureScan MRI medtronic bladder stimulator mri safety 3058 only number! Device Recall InterStim ( TM ) system after MRI procedures are potentially hazardous and can lead serious. 0000009089 00000 n 0000028899 00000 n if using an MRI SureScan device, the... For medtronic bladder stimulator mri safety 3058 a local and safe MR safety framework in InterStim II electrically... Et al anticipated results conditionally safe for: 1.5T and 3T full-body scans. An InterStim device, CD-ROM Edition.3Whitehead we, Borrud L, fzJTI4 &... Should not be used as a substitute for talking with your doctor to decide whether these are! Medtronic ( NYSE: MDT ), a video of how the InterStim in the near future 0000002263! 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