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Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. With low energy settings, the device may last up to 15 years.
The Interstim II device can be safely scanned at 1.5 T. 0000027688 00000 n
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- (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. 0000014136 00000 n
The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. Do not use if the skin in the area of use is compromised. Update my browser now. 0000006555 00000 n
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. Home For best results, use Adobe Acrobat Reader with the browser. These instructions do not apply to other implantable products, or other devices, products, or items. Treatments & Therapies 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. 0000018245 00000 n
2013;100:959968. 0000007383 00000 n
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Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 0000013304 00000 n
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Accessed July 19, 2016.5Dmochowski RR, Newman DK.
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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. We are Medtronic. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. 0000016458 00000 n
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This site is Exclusively Sponsored by BRACCO.
Patients with InterStim SureScan MRI leads only. How sacral nerve stimulation neuromodulation works. This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. 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. 0000005793 00000 n
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Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. 0000005042 00000 n
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This small device will improve patient satisfaction and reduce hospital readmissions. The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. These updates also allow for a shorter waiting time between MRI scans.
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These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. 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. 0000017228 00000 n
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How sacral nerve stimulation neuromodulation works. 0000023686 00000 n
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(8^T?Z$$0r 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. 0000011431 00000 n
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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 . nmVe:D\YC]R Ab Z
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).
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Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. 2005;32:1118. "; 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:"??
MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000005225 00000 n
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Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 0000016706 00000 n
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.
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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 . 0000024733 00000 n
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A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . 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. 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. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins.
Save my name, email, and website in this browser for the next time I comment. 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. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF.
You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. %PDF-1.3
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You must demonstrate an appropriate response to the evaluation to be a candidate. ?? 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. Methods: Eight MRI examinations at 1.5Tesla were conducted in areas outside the pelvis on six patients with implanted sacral nerve stimulator (InterStim neurostimulator; Medtronic, Inc, Minneapolis, MN, USA). 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. 2M
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D3 ?? Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. Exercise caution for patients with heart problems. 0000018445 00000 n
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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). 0000010287 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. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. Learn the parameters of patient selection for bladder control and bowel control. ;zrz'm,E*|3;aB.v` qRy
The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3.
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Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn.
Bladder Control 0000018755 00000 n
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Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs).
Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. 0000008350 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. He or she works closely with the MR medical director and MR safety officer. See approved labeling for details. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 0000013412 00000 n
Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Less information (see less). 0000025529 00000 n
Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website.
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It is safe and effective.
Sacral Neuromodulation Systems If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. Please talk to your doctor to decide whether these therapies are right for you. 0000010503 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). Click OK to confirm you are a Healthcare Professional. 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. H\V7+KJ}Rs%0+JiRJ!sC[ySsLj5I/y]bqUG22&~[kWq4 @|K
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*%4rv),^-u`3t8qgtsm,).c3Dn #,3iP'[. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Br J Surg. However, it is important to consider the risk posed by your specific MRI scan parameters. Healthcare Professionals Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people across 150 countries. These therapies are not for everyone. 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. Hg1}Y@d3}quQ D~+
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Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Your use of the other site is subject to the terms of use and privacy statement on that site.
a)&|@a3ix g].3&^.jFMO5a Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device. In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility.
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MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. 0000007828 00000 n
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. 0000018809 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.
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The clinician uses the Clinician app to . 0000008679 00000 n
Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. <>
View MRI guidelines in the MRI Resource Library.
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Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. y=9iK}xxyC]i2q~6KoNXqUDLJoNCk/_/y@6,6)SuMA<8XUJa!,kW0@'.I*'EluWII)4c1jG2,AAz(e`a`P@9dEb1
B2QPHbD (lT Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. 0000016308 00000 n
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MRI-safety expert performed a patients MRI, MRI guidelines expand the range of scan parameters, Kiaraakitty Before Surgery Plastic Surgery, Net Worth. Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation.
This manual provides information for use in estimating battery longevity (the number of months or years that the 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. World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. 0000000696 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.
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With an updated browser, you will have a better Medtronic website experience. 756 129
De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). 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. 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 1.5T and 3T head coil MRI scans. startxref
Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG.
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Products However, several studies have shown no serious adverse outcomes. "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.
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. 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. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. Search by model name, product name, or device type. The manufacturers sterilize the products after they are packaged and it lasts so many years. Patients with InterStim MRI Leads only. 0000008051 00000 n
However, it is important to consider the risk posed by your specific MRI scan parameters. However, if the conditions for safe MRI are
+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. ", "We're on a mission to expand access to proven nerve stimulation therapies through technology advancements like InterStim X, InterStim Micro, SureScan MRI technology and the smart programmer, by offering patients personalized therapy options and by reaching them through direct-to-consumer marketing," said Mira Sahney, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. J Manag Care Pharm.
&)k1}Ym@,C#k[q}[n ?? 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. 2009;137: 512-517.4United States Quick Facts. 0000004448 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 0000006938 00000 n
Not for human use in the US. Impact of overactive bladder on women in the United States: results of anational survey. These instructions do not apply to other implantable products, or other devices, products, or items. 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. 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. 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 xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J 0000009458 00000 n
REFERENCE