y=9iK}xxyC]i2q~6KoNXqUDLJoNCk/_/y@6,6)SuMA<8XUJa!,kW0@'.I*'EluWII)4c1jG2,AAz(e`a`P@9dEb1 B2QPHbD (lT hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE These instructions do not apply to other implantable products, or other devices, products, or items. 0000005225 00000 n Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 0000005793 00000 n The InterStim II Model 3058 Neurostimulator is not rechargeable. HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y 0000011431 00000 n 446 0 obj <>stream 0000014674 00000 n {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 301 0 obj <> endobj 0000005392 00000 n Urol Clin North Am. 1.5T and 3T upper and lower extremity MRI scans. Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. 0000004448 00000 n Please talk to your doctor to decide whether these therapies are right for you. 0000025529 00000 n Br J Surg. 0000025647 00000 n 0000001682 00000 n stream Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. 0000008727 00000 n 0000010169 00000 n 0000016814 00000 n 0000006753 00000 n For applicable products, consult instructions for use onwww.medtronic.com/manuals. 0000004995 00000 n MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000008625 00000 n 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 . endstream endobj 307 0 obj <>stream Click OK to confirm you are a Healthcare Professional. This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 0000005535 00000 n 0000009993 00000 n This contraindication was due to heating of the electrodes, which could damage neural tissue. 323 0 obj <>/Filter/FlateDecode/ID[<28836736925E656CEC1D4A45F6B26EFC><9F3AF6A1190447458124BACAF1002E60>]/Index[301 49]/Info 300 0 R/Length 113/Prev 1197727/Root 302 0 R/Size 350/Type/XRef/W[1 3 1]>>stream Those lucky few will benefit from this devices latest enhancements. 0000065437 00000 n 0000010041 00000 n 0 0000003937 00000 n 0000000696 00000 n 0000019081 00000 n You may choose to re-enter your serial number, or contact Medtronic at one of the numbers below: Information for Healthcare Providers US Technical Services Department. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 9>sa6 ~Ay@Z/l^/!6pLb+{Mk See approved labeling for details. This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. Patients Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 0000027856 00000 n ?? Historically, patients with implantable SNM devices have been contraindicated for MRI. 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. 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). In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. MRI, inform the MRI technologist immediately and then contact your doctor. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. <<643BDC4F02F463BA264A9A2366C35000>]>> Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. 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: Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). 0000013304 00000 n +yLKxN5F`W82r Sacral Neuromodulation Systems MRI-safety expert performed a patients MRI, MRI guidelines expand the range of scan parameters, Kiaraakitty Before Surgery Plastic Surgery, Net Worth. 0000013460 00000 n How sacral nerve stimulation neuromodulation works. With an updated browser, you will have a better Medtronic website experience. Update my browser now. 2009;15(9):728-740. 0000008924 00000 n 0000009317 00000 n Your use of the other site is subject to the terms of use and privacy statement on that site. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. The manufacturers sterilize the products after they are packaged and it lasts so many years. 0000009137 00000 n Expiration dates have mostly to do with sterilization and not the integrity of the product. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. More information (see more) However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. 0000008397 00000 n Information on this site should not be used as a substitute for talking with your doctor. 0000010287 00000 n Although many patients may benefit from the use of these treatments, results may vary. . 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. 0000006657 00000 n 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. 2009;137: 512-517.4United States Quick Facts. Bladder Control 0000018707 00000 n He or she also provides advice on non-routine MR procedures. User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help Between NBV133037H and NBV133063H ? %PDF-1.3 % 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. 756 0 obj POR can occur when there is a temporary fluctuation in battery voltage (eg . InterStim II. 0000024733 00000 n We are Medtronic. 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. "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. trailer startxref 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. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 0000008298 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. With an updated browser, you will have a better Medtronic website experience. He or she works closely with the MR medical director and MR safety officer. If you are a doctor, you should be familiar with MRI safety guidelines. 0000006023 00000 n 0000010323 00000 n 0000016760 00000 n However, it is important to consider the risk posed by your specific MRI scan parameters. 0000002263 00000 n endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. Actual results may differ materially from anticipated results. Products 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. This therapy is not intended for patients with a urinary blockage. . endstream endobj startxref 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 0000023451 00000 n 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 Impact of overactive bladder on women in the United States: results of anational survey. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. REFERENCE