It was reported to nevro that the patient acquired an infection at the ipg site. ����t���@�����\U���)�*� C��l Please note that product literature varies by geography. NIPG: Opn/Lnk see NIPG site . The reported swelling had resolved and the patient had recovered. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. Discover how Nevro gives you more evidence, more programming versatility, and more patient support to help your patients get back to what they love. AccessGUDID - Nevro® (00813426020282)- IPG Template Kit. NOTE: The official NIGP Commodity Book is copyrighted material to be used for reference purposes only and may not be reproduced without a license from Periscope Holdings, Inc. Nevro attempted to obtain additional information regarding the nature of the infection, but none was available. 1 Throughout this website all referenced SCS system components including the Implantable Pulse Generator (IPG), Leads, and Accessories are a part of the Senza System. h�bbd```b``�"ׂH��`0�D2'�ɻ`�`�*��f��j�ق`�L~�, rn�d��b�L��z ��Dr�Ɋ���H��T�����z����L�?��;� ��g GMDN Names and Definitions: © Copyright GMDN Agency 2015. endstream endobj 1337 0 obj <. The device was removed and there have been no reports of further complications regarding this event. This is a single-use device. Analgesic spinal cord electrical stimulation system. Nevro Corporation (formerly NBI Development) was founded in 2006 by Dr. Konstantinos Alataris. h�b```�#�,��@(�������A�E��M�E��ð�I��Q�Q`�|�$�&F� UI&��6V�0msx��7�� Treating pain requires flexibility and persistence. AccessGUDID - Senza® (00813426020015)- Senza® IPG Kit. The device was not returned. Nevro Percutaneous Leads LEAD10x8-xx(B): LEAD1058-50(B), LEAD1058-70(B), LEAD1058-90(B) Surpass™ Surgical Lead LEAD3005-xx(B): LEAD3005-50(B), LEAD3005-70(B), LEAD3005-90(B) Lead Anchors All models (ACCK5000, ACCK5101, ACCK5200, ACCK5300) IPG Port Plug All models (ACCK7000) x = Electrode spacing in mm xx = Lead length in cm Component Model Number(s) Lead … 23 Centimeter Band - 1240.000 to 1300.000 MHz. endstream endobj startxref YOU ARE ABOUT TO ACCESS A WEBSITE INTENDED FOR THE RESIDENTS OF A PARTICULAR COUNTRY OR REGION. Global Unique Device ID: 00813426020015. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. Instructions for Downloading Viewers and Players. The manufacturing and sterilization records were reviewed, and no non-conformities were found related to the nature of the complaint. Version (Model) Number: NIPG1500. An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). Stimulator, Spinal-Cord, Totally Implanted For Pain Relief. GMDN Names and Definitions: © Copyright GMDN Agency 2015. 1373 0 obj <>stream %%EOF As a result, the site may contain information on medical devices and other products or uses of those products that are not approved in other countries or regions. 1361 0 obj <>/Filter/FlateDecode/ID[<0696006BD7EE99469322B9EC7F30F385>]/Index[1336 38]/Info 1335 0 R/Length 119/Prev 1123674/Root 1337 0 R/Size 1374/Type/XRef/W[1 3 1]>>stream Frequency Offset Tone Location Call Sponsor Notes; 144.2000: simplex : National SSB Simplex Calling Freq ... 927.2500: 902.2500: 114.8: Krell - Spokane: W7RGW: W7RGW . Discover the Latest Nevro News, Evidence, and Events. Indiqué pour un usage intensif et une utilisation dans des conditions extrêmes. Device Name: Senza® IPG Kit. NEVRO CORP. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG2500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 08/04/2020: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non-conformities were found related to … Note: If you need help accessing information in different file formats, see Company Name: NEVRO CORP.. For Patients. Automatisme NICE pour portail coulissant trés lourd Descriptif:. Moteur bloquant NICE, alimentation en 230 Volts avec logique de commande incorporée, fin de course électromécanique pour portail coulissant jusqu'à 2500 kg. 0 Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. GMDN Preferred Term Name GMDN Definition; Analgesic spinal cord electrical stimulation system By clicking "YES" you confirm your understanding of this disclaimer and attest that you are a health care professional. The manufacturing record for this device was reviewed and no nonconformities were found. 2 Meter Band - 144.000 to 148.000 MHz. More Frequency and Waveform Versatility. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. The Menlo Park, CA company developed a pain management concept that originated at the Mayo Clinic into a spinal cord stimulation system for back and leg pain. Stimulator, Spinal-Cord, Totally Implanted For Pain Relief. Explore how HF10 ® may help you find relief from chronic pain without drugs or major surgery so you can get back to enjoying life. Labeling does not contain MRI Safety Information. 1.5T only) & head and extremity scans (1.5T and 3T) under specified conditions: Table 2: SENZA system components that are ONLY eligible for head and extremity MRI scans only (1.5T and 3T) with transmit/receive head or transmit/ receive local coils under specified conditions: . Nouvelle Mise à jour Géant GN 250 / 2500 HD NEW 18 10 2017 New update Géant GN-2500 / 2500 HD NEW V1.85 (V1.09.18486) Géant GN 2500 /2500 HD NEW 1 85 Nouveau dans les mises à jour est: Fix SERVER internet Cela peut poser quelques problèmes 2017 18 10 2017 mise à jour GEANT GEANT GN 2500 / 2500 … Nevro said it hopes to have the Senza device on the U.S. market by early 2016 if approved by the FDA. The device was not explanted. %PDF-1.6 %���� Manuals are subject to change; the most current version is available on this page. Instructions for Downloading Viewers and Players. A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. GMDN Preferred Term Name GMDN Definition; Surgical implant template, single-use NEVRO CORP SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Seroma (2069) Event Date 07/22/2016: Event Type Injury Manufacturer Narrative The device was not explanted. Nouvelle Mise à jour GN-2500 HD / 2500 HD NEW 1.71 02-01-2017 New update Géant GN-2500 HD / 2500 New V 1.71 Nouveau dans les mises à jour est d’améliorer le fonctionnement du serveur Internet الجديد في التحديثات هو تحسين عمل سيرفر النت Géant 2500 / 2500 HD NEW V 1.71 02-01-2017 GN-2500 HD PLUS,hd,2500 … NEVRO CORP. : News, information and stories for NEVRO CORP. | Nyse: NVRO | Nyse 1336 0 obj <> endobj Brand Name: Senza® . Omnia offers the most waveforms in a single product and can be programmed to provide waveforms independently or pair HF10 with other waveforms, enabling dual mechanisms of action that no other system can offer. LEARN MORE. It was reported to nevro that a patient experienced swelling over the ipg site following the implant procedure. The swelling was drained and the patient has recovered without sequelae. HF10 and other available SCS frequencies and waveforms are delivered by Senza Spinal Cord Stimulation (SCS) systems. Use only product literature from the region where the patient procedure was performed. As a result the site may contain information on medical devices and other products or uses of those products that are not approved in your country or region. S���Ss�����eT��X��M��X�� ��WƅO��T�+�j�@�����N�e��dQ8gd�ʝ�_����z����� �4�64T*Y|��������I�����Y���'�T*�gu�&�'5/.Vr���3m�`_�ҕ��T�f��md��Wrkw9_�b �#73�R�����v*��rl(X��Dg�&���-B�U����*_��I��L6�C�&lڱ�V�QE�m�N��JO똲��.���]��0��rO�p�ۨ���V9mA�n�he|��٣�����;:8�!�^d00[ttt���e`��BJ`qF ����T\Pţ��� �`T���3�aL��9��B���h� I A߾�@Z���"f���ϘB�t��3Mbz�������m��}L��t5�D��``�j9�p�a��,�k~~~ �OLL)�����1(0J2h��3|g��s�̗A�u5�[ LEARN MORE. Device was not explanted. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective. It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. The following table lists components of the SENZA system that are MR Unsafe. The physician stated that there was no infection and no antibiotics were given to the patient. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Adverse Event Without Identified Device or Use Problem (2993), Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Adverse Event Without Identified Device or Use Problem (2993), Instructions for Downloading Viewers and Players. Reproduced with Permission from the GMDN Agency.
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