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 . Hg1}Y@d3}quQ D~+
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Methods. MRI, inform the MRI technologist immediately and then contact your doctor. The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . It should be used after you have tried other treatments such as medications and behavioral therapy and they have not worked, or you could not tolerate them.
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These updates also allow for a shorter waiting time between MRI scans.
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9850 NW 41st Street, Suite 450, Doral, FL 33178 If you are a doctor, you should be familiar with MRI safety guidelines. 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. 0000023719 00000 n
b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF.
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. "This is not your grandmother's therapy. Current Medical Research and Opinion.
This contraindication was due to heating of the electrodes, which could damage neural tissue. This manual provides information for use in estimating battery longevity (the number of months or years that the trailer
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. 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. 0000018959 00000 n
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Unintended Stimulation MRI may cause unintended stimulation from the implant.
Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. . hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y
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View MRI guidelines in the MRI Resource Library. Search for downloadable product manuals by product name or model number. Save my name, email, and website in this browser for the next time I comment. J Manag Care Pharm.
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It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. 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. 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. 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. 0000014881 00000 n
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Home Historically, patients with implantable SNM devices have been contraindicated for MRI. 0000004494 00000 n
More information (see more) 0000016706 00000 n
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Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. Ll2@108 Although many patients may benefit from the use of these treatments, results may vary. 0000010106 00000 n
ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. xref
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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 Healthcare Professionals The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. Gastroenterology. 0000018055 00000 n
- (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. Information on this site should not be used as a substitute for talking with your doctor.
In fact, many of them might be considering the InterStim in the near future. Bladder Control
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Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000006023 00000 n
Accessed July 19, 2016.5Dmochowski RR, Newman DK. Those lucky few will benefit from this devices latest enhancements. 0000014184 00000 n
Expiration dates have mostly to do with sterilization and not the integrity of the product. MRI of the hand can be safely carried out with the Medtronic Interstim II device. Br J Surg. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>>
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Urological 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 About MedtronicBold thinking.
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D3 +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. 323 0 obj
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Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site.
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B2QPHbD (lT 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). 0000026803 00000 n
The FDA approved the long-lived, rechargeable, full-body MRI compatible Axonics r-SNM System in late 2019, with the first commercial sales occurring in November 2019 . 0000006753 00000 n
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Less information (see less). This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. 0000009458 00000 n
Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. 0000027688 00000 n
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The implanted InterStim II system electrically stimulates the sacral nerve, which is thought to normalise neural communication between the bladder and brainand between the bowel and brain.1,2, Medtronic Bladder Control Therapy 0000003937 00000 n
+yLKxN5F`W82r The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. 0
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The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. 0000008051 00000 n
Click OK to confirm you are a Healthcare Professional.
Urol Clin North Am. 0000010222 00000 n
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2013;100:959968.
2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. 0000023686 00000 n
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Treatments & Therapies For best results, use Adobe Acrobat Reader with the browser. 0000013460 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). Between NBV133037H and NBV133063H ? 0
Search by model name, product name, or device type. 0000008298 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. 0000018707 00000 n
Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System.
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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). Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. 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. 0000023451 00000 n
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Patients
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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 Interstim II device can be safely scanned at 1.5 T. 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. However, if the conditions for safe MRI are Less information (see less).
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j These treatments are prescribed by your doctor.
The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. a)&|@a3ix g].3&^.jFMO5a
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MRI mode is easy for patients to independently activate or deactivate on the smart programmer.
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You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. "; 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:"?? 0000008397 00000 n
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. 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. It is safe and effective. 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). }$Y? Between NBV628045S and NBV628263S MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure. World J Urol. That said, you have to ask yourself, are you a patient?
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With an updated browser, you will have a better Medtronic website experience. The purpose of the MR safety expert is to minimize risk and optimize scan plans. nmVe:D\YC]R Ab Z We are Medtronic. The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). Patients with InterStim MRI Leads only. 0000025529 00000 n
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. Update my browser now. 0000010599 00000 n
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These components are well depicted on a standard radiograph. See approved labeling for details. 2009;137: 512-517.4United States Quick Facts. 0000007625 00000 n
Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 2005;32:1118. 0000012969 00000 n
?? This therapy is not intended for patients with a urinary blockage. MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. 0000007197 00000 n
MR safety expert is a person who is responsible for developing a local and safe MR safety framework. 0000008924 00000 n
Patients with InterStim SureScan MRI leads only. p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{
Update my browser now. Sacral Neuromodulation Systems If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o
Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device.