User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help About MedtronicBold thinking. 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. 0000012617 00000 n
2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al.
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Under certain conditions.
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Update my browser now. SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! Update my browser now. The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStimu001d neurostimulators for sacral neuromodulation therapy. 0000001914 00000 n
The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. United States Census Bureau Web site. With an updated browser, you will have a better Medtronic website experience.
- (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. The manufacturers sterilize the products after they are packaged and it lasts so many years.
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InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. <<643BDC4F02F463BA264A9A2366C35000>]>>
However, if the conditions for safe MRI are Search for downloadable product manuals by product name or model number. Information on this site should not be used as a substitute for talking with your doctor. Home hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y
[> Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 0000011083 00000 n
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Urol Clin North Am. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 0000002333 00000 n
If you are a doctor, you should be familiar with MRI safety guidelines. I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com.
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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. The good news is that many physicians are already familiar with the subject.
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NEUROSTIMULATION SYSTEM: INTERSTIM THERAPY SACRAL NERVE STIMULATION (SNS) FOR URINARY CONTROL MRI Guidelines for InterStim Therapy Neurostimulation Systems MR Scanning Conditions MR Conditional: Non-clinical testing has demonstrated that InterStim Therapy systems have been found to be MR Conditional. 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 . This site is Exclusively Sponsored by BRACCO. 0000017618 00000 n
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b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. 756 129
More information (see more) startxref
"; 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:"?? In fact, many of them might be considering the InterStim in the near future. The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. Accessed July 19, 2016.5Dmochowski RR, Newman DK. Always talk with your doctor about diagnosis and treatment information. 0000023686 00000 n
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Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only) Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans: ? 0000008924 00000 n
Ll2@108 MRI: Testing of the VOCARE Bladder System/Finetech-Brindley Bladder System (Vocare) in a 1.5-Tesla scanner with a maximum spatial gradient of 450 gauss/cm or less, exposed to an average Specific Absorption Rate (SAR) of 1.1 W/kg, for a 30 minute duration resulted in localized temperature rises up to 5.5?C in a gel phantom (without blood flow . 0000004995 00000 n
Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. {eH3zAsW[@9]E.}(ku4}0g{QsyzIOurFvDlM/6H7h*0ZZ5wp8'J={Z6yWkitXLq}l~Ke*Ra{6W"%{.N" %]B&m}AO_=
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4.2. 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. 0000014674 00000 n
He or she also provides advice on non-routine MR procedures. 5Z\&l:|iXeMt+Z5|L| 1v
3tT#`K?FWrS8% Questions and Answers in MRI - MRI Questions & Answers; MR imaging . 1Stewart WF, et al. 0000018197 00000 n
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This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. The latest InterStim is a small, discreet device, making it a safe option for many.
2013;100:959968. 0000023883 00000 n
Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device. We are Medtronic. You must demonstrate an appropriate response to the evaluation to be a candidate. It is possible that some of the products on the other site are not approved in your region or country. 0000005225 00000 n
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However, it is important to consider the risk posed by your specific MRI scan parameters. Between NBV133037H and NBV133063H ?
This therapy is not intended for patients with a urinary blockage. Current Medical Research and Opinion. p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{
This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). 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. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000000016 00000 n
However, it is important to consider the risk posed by your specific MRI scan parameters. Historically, patients with implantable SNM devices have been contraindicated for MRI.
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;@xR+ In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. MRI-safety expert performed a patients MRI, MRI guidelines expand the range of scan parameters, Kiaraakitty Before Surgery Plastic Surgery, Net Worth. Treatments & Therapies The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3.
If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. 0000124808 00000 n
Prevalence and burden of overactive bladder in the United States. MR safety expert is a person who is responsible for developing a local and safe MR safety framework.
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). Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc.
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Learn how to turn the InterStim neurostimulator on and off with a Interstim iCon programmer.If you've tried other treatments but are still suffering from bla. 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. Patients with InterStim SureScan MRI leads only. Less information (see less). 2013;100:959968. H\V7+KJ}Rs%0+JiRJ!sC[ySsLj5I/y]bqUG22&~[kWq4 @|K
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+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.
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. "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. Hg1}Y@d3}quQ D~+
Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. 2005;32:11-18. 0000006684 00000 n
Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 0000012800 00000 n
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?? It is safe and effective. 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).
De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). hb```f``:2AX,
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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.
Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. 0000005584 00000 n
The clinician uses the Clinician app to . InterStim II Model 3058 Neurostimulator Table 1. 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. Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o
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Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. 0000023177 00000 n
2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. neurostimulator will provide stimulation at programmed settings before requiring recharge). 0000018863 00000 n
Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000008625 00000 n
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
Home InterStim II. 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. 0000012062 00000 n
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These updates also allow for a shorter waiting time between MRI scans.
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Br J Surg. Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people across 150 countries. xref
Search for downloadable product manuals by product name or model number. 0000009883 00000 n
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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. This manual provides information for use in estimating battery longevity (the number of months or years that the 427 20
For applicable products, consult instructions for use onwww.medtronic.com/manuals. 0000008003 00000 n
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Healthcare Professionals POR can occur when there is a temporary fluctuation in battery voltage (eg . Actual results may differ materially from anticipated results. Not for human use in the US. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. 0000007197 00000 n
J Manag Care Pharm. 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. 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. That said, you have to ask yourself, are you a patient?
The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 0000004448 00000 n
<<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>>
nmVe:D\YC]R Ab Z Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans.
With low energy settings, the device may last up to 15 years. hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE 0000006555 00000 n
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. aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h If you continue, you may go to a site run by someone else. 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. 0000006231 00000 n
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2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." 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). You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. "; 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:"?? Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 0000027688 00000 n
Important note: Each device ind. }$Y? Save my name, email, and website in this browser for the next time I comment.
Expiration dates have mostly to do with sterilization and not the integrity of the product. However, several studies have shown no serious adverse outcomes.
Impact of overactive bladder on women in the United States: results of anational survey. endstream
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These instructions do not apply to other implantable products, or other devices, products, or items. When the battery is depleted, the neurostimulator must be replaced.
View MRI guidelines in the MRI Resource Library. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. 0000009089 00000 n
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Manuals can be viewed using a current version of any major internet browser. These instructions do not apply to other implantable products, or other devices, products, or items. 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. However, the safety of MRI of other body regions in InterStim II patients remains uncertain. This therapy isappropriatefor bladder control patients who: This therapy isnot appropriatefor bladder control patients who: Many patients with chronic FI have poor or reduced quality of life because of their symptoms. 0000008727 00000 n
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). 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.
Get the details on specific MRI compatibility for neuromodulation therapies. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. Although many patients may benefit from the use of these treatments, results may vary. 0000016814 00000 n
?? Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). Methods. Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. 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. This small device will improve patient satisfaction and reduce hospital readmissions. Leng WW, Chancellor MB. 0000013460 00000 n
InterStim II. . 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. Sacral Neuromodulation Systems The Interstim II device can be safely scanned at 1.5 T. 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. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Medtronic at the back of this Manual if you have an implanted to... You have an InterStim device New Technologies and Applications in sacral Neuromodulation: an Update Ther. 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