427 0 obj
<>
endobj
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. endstream
endobj
302 0 obj
<>
endobj
303 0 obj
<>
endobj
304 0 obj
<>stream
0000009883 00000 n
MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe.
0000023883 00000 n
Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 0000004372 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 . Patients with InterStim MRI Leads only. Fecal incontinence in US adults: epidemiology and risk factors.
These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. {eH3zAsW[@9]E.}(ku4}0g{QsyzIOurFvDlM/6H7h*0ZZ5wp8'J={Z6yWkitXLq}l~Ke*Ra{6W"%{.N" %]B&m}AO_=
W#aW&0]rPN1uyee9nOO(t.D00
1poJMWQBw)snRadpx.-` Z
In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, lead (thin wire) movement/migration, device problems, interactions with certain other devices or diagnostic equipment such as MRI, undesirable changes in urinary or bowel function, and uncomfortable stimulation (sometimes described as a jolting or shocking feeling). 0000014626 00000 n
The InterStim II Model 3058 Neurostimulator is not rechargeable. The manufacturers sterilize the products after they are packaged and it lasts so many years. 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 . 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. "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. 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. Unintended Stimulation MRI may cause unintended stimulation from the implant. However, several studies have shown no serious adverse outcomes. %%EOF
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. 0000028899 00000 n
0000012610 00000 n
0000006184 00000 n
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. These components are well depicted on a standard radiograph. Between NBV133037H and NBV133063H ? 0000009137 00000 n
0000023719 00000 n
hb```f``:2AX,
N
qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02,"
@ANNbb@,
~k]hz$Mp 0000008679 00000 n
These therapies are not for everyone.
Search for downloadable product manuals by product name or model number. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. trailer
%%EOF
The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE 0000010222 00000 n
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. 427 20
0000013412 00000 n
nmVe:D\YC]R Ab Z
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.
0000010503 00000 n
It is safe and effective. Prevalence and burden of overactive bladder in the United States. 0000013304 00000 n
The Interstim II device can be safely scanned at 1.5 T. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. Although many patients may benefit from the use of these treatments, results may vary. 0000041486 00000 n
The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3.
Your use of the other site is subject to the terms of use and privacy statement on that site.
0000005846 00000 n
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 About MedtronicBold thinking. 0000009645 00000 n
0000012617 00000 n
+yLKxN5F`W82r Not for human use in the US. The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. MRI of the hand can be safely carried out with the Medtronic Interstim II device. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 0000008245 00000 n
De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 0000024733 00000 n
When the battery is depleted, the neurostimulator must be replaced. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1.
These instructions do not apply to other implantable products, or other devices, products, or items. The Interstim II device can be safely scanned at 1.5 T. However, to safely achieve this feat, it is important to choose a suitable coil, use a corresponding hand coil, and position the patient in a way that minimizes the likelihood of heating. This contraindication was due to heating of the electrodes, which could damage neural tissue. Exercise caution for patients with heart problems. 0000012562 00000 n
@J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5
P&Dg*[@K6WrqFKe]3 For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. ?? Implanted pulse generators were examined before and after MRI procedures. I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J
Sacral Neuromodulation Systems Questions and Answers in MRI - MRI Questions & Answers; MR imaging .
Rh)b#0a(Z)#!H
Bb*acH@L
Q 9 , p043/aeSe3JEANr3>-u8wFXGp. Search for downloadable product manuals by product name or model number.
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: World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al.
endstream
endobj
305 0 obj
<>stream
This therapy is not intended for patients with a urinary blockage. 756 0 obj
0
0000011527 00000 n
Accessed July 19, 2016.5Dmochowski RR, Newman DK. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. If you are a doctor, you should be familiar with MRI safety guidelines. User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help 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. Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room.
Update my browser now. endstream
endobj
306 0 obj
<>stream
0000010599 00000 n
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>>
0000023020 00000 n
JbN}&Kt]FV~Uj_JK
p
a4! :}\ UxIM#ufX'z4WcHqFtEmXO0Su_[q/]&SZhz19>uK$V4} 1 kG,M^jaRv,gIvO& +x4pU.Vw 33/Ax/M>s["-89@ S$}D
l~v626Zr 6o2ulSs?z=^!e/(k&zbxgn-p]o`vl@mv9670>=/o.HU}d~z6X{icp{y
X]_ That said, you have to ask yourself, are you a patient? igXOs!i']}E]Zxu#udHK}}{wMW~ia>=ekO
zw,a_MfT\R "}con}l%BU?8>`MO{zcIRv2P,k{fXY0p0iX}Tk([orZjZEsh)v0:oHcg[_3/BX\>_7#-nLo.bpoUu~vwX"h 1Pc=r"5(K^4I@@G'AE*p N <<643BDC4F02F463BA264A9A2366C35000>]>>
%PDF-1.3
%
The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. MRI, inform the MRI technologist immediately and then contact your doctor. xref
0000007038 00000 n
0000017893 00000 n
This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). Leng WW, Chancellor MB. 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 . 0000018707 00000 n
0000008727 00000 n
InterStim II. Update my browser now. trailer
0000016706 00000 n
?? 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. 0000124808 00000 n
0000009598 00000 n
0000014184 00000 n
0000006231 00000 n
The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. 0000011192 00000 n
You just clicked a link to go to another website.
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. Historically, patients with implantable SNM devices have been contraindicated for MRI. [UeK[Xe;vmy65R$yFi
Br J Surg. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000065437 00000 n
Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only) Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans: ? 0000008954 00000 n
The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws.
}$Y? 0000011240 00000 n
0000004467 00000 n
MRI safety guidelines from Medtronic have expanded the range of scan parameters that clinicians can use to provide patients with a comprehensive, reliable, and safe MRI experience. a)&|@a3ix g].3&^.jFMO5a You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. MR safety expert is a person who is responsible for developing a local and safe MR safety framework. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000009993 00000 n
0000019081 00000 n
Expiration dates have mostly to do with sterilization and not the integrity of the product. /mBJ-tX/nk}I_.MRs4_ Z@`XJ$
lg~DDL^8!p4-T *\&NTok*^e\zU>ZaSF8"dyJ,rq)9\v67#FQ|FCYH
!y+*12p1dbKj)(Ljg7S hb```b``^d(31 PCAed a2(m``_XA
-cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg
t7eD,zorsaR;
;@xR+ Implanted pulse generators were examined before and after MRI procedures. ' a9.aacz3CSoTz)_%v 0000012800 00000 n
. 0000007197 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. The purpose of the MR safety expert is to minimize risk and optimize scan plans. Get the details on specific MRI compatibility for neuromodulation therapies. InterStim II Model 3058 Neurostimulator Table 1. endstream
endobj
428 0 obj
<. 0000015970 00000 n
9850 NW 41st Street, Suite 450, Doral, FL 33178 0000004448 00000 n
. 301 0 obj
<>
endobj
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. 0000001682 00000 n
Impact of overactive bladder on women in the United States: results of anational survey. Home 0000013017 00000 n
Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. startxref
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. Current Medical Research and Opinion. 5Z\&l:|iXeMt+Z5|L| 1v
3tT#`K?FWrS8% 0000006555 00000 n
Bolder actions.
It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. POR can occur when there is a temporary fluctuation in battery voltage (eg .
Less information (see less). - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. 0000008051 00000 n
;zrz'm,E*|3;aB.v` qRy
0000014402 00000 n
0000018055 00000 n
There have been few studies evaluating the risk of MRI in patients with this implant. <>
Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 0000007828 00000 n
0000010106 00000 n
Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) ?? 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). The only products we caution customers about are ones that are absorbable or drug coated. 0000025647 00000 n
j
Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000017618 00000 n
0000006501 00000 n
0000016362 00000 n
ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. 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.
Under certain conditions; see approved labeling for details.
Under certain conditions. 0000023686 00000 n
All patients had their parameters recorded; then the IPGs were put to "nominal" status.
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. 756 129
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. Pelvic floor disorders network. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y.
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). "This is not your grandmother's therapy. 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. REFERENCE