InterStim II. Please talk to your doctor to decide whether these therapies are right for you. 0000005583 00000 n 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). 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. Manuals can be viewed using a current version of any major internet browser. Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 0000025647 00000 n 0000000016 00000 n It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. 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). The clinician uses the Clinician app to . Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. Less than NBV132955H ? Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. ", More than 37 million adults in the United States almost one in six suffer from overactive bladder (OAB),1,2 and nearly 18 million Americans about one in 12 are living with fecal incontinence.3,4 Many sufferers limit their lives socially, professionally, and personally.5 However, as many as 45% who suffer from symptoms do not seek treatment and as many as seven in 10 stop using medications within six months due to intolerable side effects or unsatisfying results.6,7,8. The good news is that many physicians are already familiar with the subject. 0000007430 00000 n These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. ?? trailer 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. 0000023883 00000 n 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. 0000006985 00000 n However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help He or she works closely with the MR medical director and MR safety officer. 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: Class 2 Device Recall InterStim (TM) System. 0000004045 00000 n Urol Clin North Am. Search for downloadable product manuals by product name or model number. 9850 NW 41st Street, Suite 450, Doral, FL 33178 The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. H\V7+KJ}Rs%0+JiRJ!sC[ySsLj5I/y]bqUG22&~[kWq4 @|K 0,.KKm[[E|B~\'[$NX!c3g{1-AbgQ`(3#DKp~y7GxR"X dq&+iUXN}YE2Q1G,Zr~8u"O{th8V*UQQZ [Ib"t/ hWy/__/~~r|?V%Kwp>#}TXXTP3gT9!yka X1'J$z"+vn~[i S+~nhaRUn+k]SY *%4rv),^-u`3t8qgtsm,).c3Dn #,3iP'[. 446 0 obj <>stream b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. More information (see more) 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. The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. 0000027856 00000 n More information (see more) 0000012800 00000 n He or she also provides advice on non-routine MR procedures. 0000009782 00000 n 0000009830 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. ' a9.aacz3CSoTz)_%v With an updated browser, you will have a better Medtronic website experience. 0000008350 00000 n 0000004713 00000 n 0000018055 00000 n Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) 0000005225 00000 n MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Between NBV133037H and NBV133063H ? Healthcare Professionals 0000010275 00000 n 427 20 0000015308 00000 n The latest InterStim is a small, discreet device, making it a safe option for many. REFERENCE