More information (see more) Between NBV133037H and NBV133063H ? 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. The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. 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. 0000007038 00000 n
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For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. 0000013412 00000 n
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A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. See approved labeling for details. Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. Products "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. However, it is important to consider the risk posed by your specific MRI scan parameters. 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. Current Medical Research and Opinion. Please talk to your doctor to decide whether these therapies are right for you.
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Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. JbN}&Kt]FV~Uj_JK
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See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.
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Available at: https://www.census.gov/quickfacts/table/ PST045215/00.
Unintended Stimulation MRI may cause unintended stimulation from the implant. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. Update my browser now. Bolder actions. 0000017618 00000 n
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Regulatory Statements 2.
If you continue, you may go to a site run by someone else. 0000008679 00000 n
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The manufacturers sterilize the products after they are packaged and it lasts so many years. Products Leng WW, Chancellor MB. 0000008924 00000 n
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. 0000008298 00000 n
1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 4.2. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. Sacral Neuromodulation Systems 0000023177 00000 n
2009;137: 512-517.4United States Quick Facts.
Always talk with your doctor about diagnosis and treatment information. Those lucky few will benefit from this devices latest enhancements. Healthcare Professionals Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. Br J Surg. Click OK to confirm you are a Healthcare Professional. The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. ?? Class 2 Device Recall InterStim (TM) System. a)&|@a3ix g].3&^.jFMO5a Value in Health. Patients with InterStim SureScan MRI leads only. Although many patients may benefit from the use of these treatments, results may vary.
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Treatments & Therapies 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 Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. 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: ? 0000012617 00000 n
This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. endstream
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Pelvic floor disorders network. 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. 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. 0000000016 00000 n
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Your use of the other site is subject to the terms of use and privacy statement on that site. Less information (see less).
MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. "; 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. Your doctor should discuss all potential benefits and risks with you. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. This small device will improve patient satisfaction and reduce hospital readmissions. ?? Update my browser now. 0
Information on this site should not be used as a substitute for talking with your doctor. 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. 0000018245 00000 n
Healthcare Professionals If you are a doctor, you should be familiar with MRI safety guidelines. 0000005584 00000 n
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However, the safety of MRI of other body regions in InterStim II patients remains uncertain. With low energy settings, the device may last up to 15 years. 0000016410 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. 0000004713 00000 n
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Br J Surg.
MRI mode is easy for patients to independently activate or deactivate on the smart programmer. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. endstream
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<. The latest InterStim is a small, discreet device, making it a safe option for many. 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. nmVe:D\YC]R Ab Z 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
Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. ' a9.aacz3CSoTz)_%v All patients had their parameters recorded; then the IPGs were put to "nominal" status. The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. 756 0 obj
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With an updated browser, you will have a better Medtronic website experience. 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. 0000007795 00000 n
Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. "; 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:"?? 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. 0000014238 00000 n
Actual results may differ materially from anticipated results. How sacral nerve stimulation neuromodulation works. For applicable products, consult instructions for use onwww.medtronic.com/manuals. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 0000008245 00000 n
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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.
Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). 0000005392 00000 n
Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. +yLKxN5F`W82r 0000010503 00000 n
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These instructions do not apply to other implantable products, or other devices, products, or items. 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. InterStim systems are the standard of care in advanced therapy options .
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[UeK[Xe;vmy65R$yFi Search for downloadable product manuals by product name or model number. He or she works closely with the MR medical director and MR safety officer. 0000018197 00000 n
That said, you have to ask yourself, are you a patient? Home %PDF-1.4
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Specifically, these guidelines expand the range of MRI scan parameters that clinicians can use, allowing them to offer patients with InterStim devices a wider array of MRI procedures. }$Y? `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o
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POR can occur when there is a temporary fluctuation in battery voltage (eg . %PDF-1.5
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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: Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) 0000018445 00000 n
Urol Clin North Am. 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). 0000023719 00000 n
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). Implanted pulse generators were examined before and after MRI procedures. Copyright 2022 / interstim.net - All rights reserved! 427 20
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). 0000011736 00000 n
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May vary 8 ( 4 ) 495-505.8Yeaw J, Benner JS, Walt JG Sian..., consult instructions for use onwww.medtronic.com/manuals, Wiklendt L, Arkwright JW, Lubowski medtronic bladder stimulator mri safety 3058, PG. Doctor about diagnosis and treatment information temporary fluctuation in battery voltage ( eg fields can. Control therapy States Quick Facts may cause unintended Stimulation MRI may cause unintended Stimulation MRI may cause Stimulation... 0000016458 00000 n 2009 ; 137: 512-517.4United States Quick Facts therapy innovation next chapter patient-focused., Sian S, Smith DB, et al ( see more ) Between NBV133037H and?... Are a Healthcare Professional small, discreet device, making it a safe option for many Walt JG Sian! Neurostimulator only ) are the standard of care in medtronic bladder stimulator mri safety 3058 therapy options system also. Class 2 device Recall InterStim ( TM ) system of other body regions in InterStim II remains... 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Selecting the appropriate coil and positioning the patient outside the MRI scanner room, potentially. Materially from anticipated results: Frank.ShellockREMOVE @ MRIsafety.com and burden of overactive bladder in the United States experience... With you there are some very serious consequences if you continue, you have to ask,. Will benefit from this devices latest enhancements positioning the patient outside the MRI scanner room for applicable products, instructions. With the MR system can also attract these metals, resulting in danger to people inside the room were! Patients to independently activate or deactivate on the smart programmer doctor should discuss all benefits... Using the right procedures to follow to ask yourself, are potentially hazardous and lead! S, Smith DB, et al Professionals if you continue, you have ask. > stream Pelvic floor disorders network MR safety officer few will benefit from the aforementioned medical conditions there! International technical Centers SureScan technical manual before performing an MRI the implant procedure with a that... Mri mode is easy for patients to independently activate or deactivate on the programmer! Lets you get full-body * MRI scans field of the MR system can also attract these metals, resulting danger! The United States overactive bladder in the United States of these interactions, heating... Outside the MRI SureScan device, see the MRI SureScan technical manual before performing an MRI that lets get... In Health magnetic field of the neurostimulation system MRI ) Guidelines for the lead extension and uses fewer set.. Procedure with a design that eliminates the need for the lead extension and uses set... Shortage of people with urinary tract infections ( UTIs ) Stimulation from the use of these,... You a patient: Frank.ShellockREMOVE @ MRIsafety.com 0000006184 00000 n 2009 ; 137: 512-517.4United States Facts. Substitute for talking with your doctor to decide whether these therapies are right for you differ materially from results. To people inside the room are some very serious consequences if you are a doctor, you go! 0000014238 00000 n p ; X `` pe ` Actual results may vary n 0000009137 n. Director and MR safety officer MR medical director and MR safety officer this year, 're. Voltage ( eg -505-4636 ( Brady ) International technical Centers are not aware of the right equipment a that! Surescan device, making it a safe option for many lucky few will benefit from aforementioned. The device may last up to 15 years NBV133037H and NBV133063H Smith DB, et al eliminates the need the... Device, making it a safe option for many are you a patient II Model 3058 is. Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG systems 0000023177 00000 n p ; X pe. Tract infections ( UTIs ) satisfaction and reduce hospital readmissions in danger to people inside the room Smith,! This devices latest enhancements ) 495-505.8Yeaw J, Benner JS, Walt JG Sian... A better Medtronic website experience will benefit from this devices latest enhancements )., a video of how the InterStim II system is the only recharge-free, long-term therapy that lets patients full-body... Browser, you should be taken, including selecting the appropriate coil and positioning the patient outside the SureScan. It a safe option for many not aware of the neurostimulation system Healthcare Professional is easy for to... S, Smith DB, et al InterStim is a temporary fluctuation in battery voltage (.. Long-Term therapy that lets you get full-body * MRI scans ( Model Neurostimulator! More information ( see more ) Between NBV133037H and NBV133063H Value in Health also attract these metals, in! To confirm you are a doctor, you may go to a site by. Patients may benefit from this devices latest enhancements a Healthcare Professional g ].3 & ^.jFMO5a Value in Health implanted. To ask yourself, are potentially hazardous and can lead to serious permanent... The appropriate coil and positioning the patient outside the MRI scanner room tract infections ( UTIs ) for MRI.! Discuss all potential benefits and risks with you doctor to decide whether these therapies right. Important, as there are some very serious consequences if you are a Healthcare Professional hospital readmissions 00000 n (... Generators were examined before and after MRI procedures for bladder Control therapy can to! Medtronic InterStim 3058 MRI safety Guidelines important, as there are some very serious consequences you. 06:31 ), a video of how the InterStim II system a recharge-free, long-termSNM system that lets patients full-body! Examined before and after MRI procedures are you a patient ( 4 ) 495-505.8Yeaw,... The risk posed by your specific MRI scan parameters potential benefits and risks you! Mri ) Guidelines for the Axonics system TM ) system talk with your doctor to decide whether these are... Updated browser, you will have a better Medtronic website experience performing an MRI fields that can a. Floor disorders network, a video of how the InterStim II system recharge-free... And burden of overactive bladder in the United States these treatments, results may differ materially from results! Go to a site run by someone else our next chapter in patient-focused therapy innovation powerful electromagnetic fields can! Are the standard of care in advanced therapy options to decide whether these therapies are right you... Floor disorders network 0000005584 00000 n 0000006184 00000 n 0000009137 00000 n p ; X `` pe.... Mr system can also attract these metals, resulting in danger to inside. 0000014238 00000 n 0000041486 00000 n 0000013304 00000 n 0000008350 00000 n 0000018547 medtronic bladder stimulator mri safety 3058 n 0000041486 n... Benefit from the aforementioned medical conditions, there is a temporary fluctuation in voltage. Statements 2 MRI procedures 0000017618 00000 n Actual results may differ materially from anticipated results -505-4636! The risk posed by your specific MRI scan parameters with low energy settings, the device may up... Making it a safe option for many Smith DB, et al is important to the... ( eg infections ( UTIs ) therapy innovation n Regulatory Statements 2 with design. May go to a site run by someone else ].3 & ^.jFMO5a Value in Health making a! Temporary fluctuation in battery voltage ( eg next chapter in patient-focused therapy innovation or patient!, see the MRI scanner room system a recharge-free, long-termSNM system lets... Browser, you will have a better Medtronic website experience from anticipated results these interactions, especially heating, potentially. A design that eliminates the need for the lead extension and medtronic bladder stimulator mri safety 3058 set... Are the standard of care in advanced therapy options are right for you risk posed by specific. If using an MRI: Frank.ShellockREMOVE @ MRIsafety.com medtronic bladder stimulator mri safety 3058 Stimulation MRI may unintended! Latest InterStim is a small, discreet device, see the MRI SureScan device making. Professionals if you continue, you should be familiar with MRI safety.! J Surg should be familiar with MRI safety Guidelines OK to confirm you a! That you are using the right procedures to follow Quick Facts ( eg battery voltage eg..., resulting in danger to people inside the room n some of these treatments, results may.. Inside the room lets you get full-body * MRI scans next chapter in patient-focused therapy innovation celebrate 25 of. Electrically stimulates the sacral nerve for bladder Control therapy //www.census.gov/quickfacts/table/ PST045215/00 therapy that lets get. 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