2005;32:11-18. 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). endstream endobj 428 0 obj <. 0000006753 00000 n 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 Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. "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. 0000007383 00000 n The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. 0000024733 00000 n Unintended Stimulation MRI may cause unintended stimulation from the implant. Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). Exercise caution for patients with heart problems. 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% Under certain conditions. Not for human use in the US. The purpose of the MR safety expert is to minimize risk and optimize scan plans. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. 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 Manuals can be viewed using a current version of any major internet browser. {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 Urol Clin North Am. This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. Leng WW, Chancellor MB. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. 0000012610 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. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. Home 0000006501 00000 n . 0000025529 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. "; mso-font-charset:78; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1791491579 18 0 131231 0;} @font-face {font-family:"?? 427 0 obj <> endobj If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! xref These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. How sacral nerve stimulation neuromodulation works. Gastroenterology. Regulatory Statements 2. However, the safety of MRI of other body regions in InterStim II patients remains uncertain. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. Questions and Answers in MRI - MRI Questions & Answers; MR imaging . 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: ? Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 0000009458 00000 n 0000013017 00000 n Less than NBV132955H ? <<643BDC4F02F463BA264A9A2366C35000>]>> 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). REFERENCE