Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study

Arthur Roberts,1–3 Alec Sithole,4 Marcos Sedghi,5 Charles A Walker,6,7 Theresa M Quinn,8 1Indiana Craniofacial Center, 2Department of Oral Pathology, Medicine and Radiology, Indiana University School of Dentistry, Indianapolis, IN, USA; 3Department of Anesthesia, Critical Care, and Pain Ma...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Roberts A, Sithole A, Sedghi M, Walker CA, Quinn TM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	The peri-auricular percutaneous implantation of the Neuro-Stim System (NSS©) family of devices EAD© MFS© BRIDGE© (Innovative Health Solutions Versailles IN) is a non-opiate neuromodulation analgesic used for acute and chronic pain conditions. It is cleared as a minimal risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleeding localized dermatitis and infections at the implantation sites of the electrode/needle arrays dermatitis at the site of the generator and patient syncope. A total of 1 207 devices each producing up to 16 percutaneous punctures for a total of 19 312 punctures were monitored for adverse effects based on retrospective chart audits conducted at 6 clinical facilities over a one-year period. Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/3a767777e98a4c1a9c6046983d71db8f
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:3a767777e98a4c1a9c6046983d71db8f
record_format	dspace
spelling	oai:doaj.org-article:3a767777e98a4c1a9c6046983d71db8f2021-12-02T01:22:17ZMinimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study1179-1470https://doaj.org/article/3a767777e98a4c1a9c6046983d71db8f2016-11-01T00:00:00Zhttps://www.dovepress.com/minimal-adverse-effects-profile-following-implantation-of-periauricula-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Arthur Roberts,1–3 Alec Sithole,4 Marcos Sedghi,5 Charles A Walker,6,7 Theresa M Quinn,8 1Indiana Craniofacial Center, 2Department of Oral Pathology, Medicine and Radiology, Indiana University School of Dentistry, Indianapolis, IN, USA; 3Department of Anesthesia, Critical Care, and Pain Management, College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, UK; 4Department of Computer Science, Mathematics and Physics, Missouri Western State University, St Joseph, MO, 5Conservative Care Specialists Medical Group, Los Angeles, CA, 6Walker Pain Management Center, Jackson, TN, 7Bethel University, Paris, TN, 8Wisconsin Pain Solutions, Menomonee Falls, WI, USA Abstract: The periauricular percutaneous implantation of the Neuro-Stim System™ family of devices EAD, MFS, and BRIDGE is a procedure involving the use of a non-opiate, neuromodulation analgesic for relieving acute and chronic pain. It has been approved as a minimal-risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleeding, localized dermatitis, and infections at the implantation sites of the electrode/needle arrays, dermatitis at the site of the generator, and patient syncope. A total of 1,207 devices, each producing up to 16 percutaneous punctures, for a total of 19,312 punctures were monitored for adverse effects, based on retrospective chart audits conducted at six clinical facilities over a 1-year period. Keywords: clinical risks and discomfort, percutaneous auricular neuro-stimulation, Neuro-Stim System™ devices, EAD, MFS, Bridge, neuromodulation, adverse effectsRoberts ASithole ASedghi MWalker CAQuinn TMDove Medical PressarticleThe peri-auricular percutaneous implantation of the Neuro-Stim System (NSS©) family of devices EAD©MFS©BRIDGE© (Innovative Health SolutionsVersailles IN) is a non-opiateneuromodulation analgesic used for acute and chronic pain conditions. It is cleared as a minimal risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleedinglocalized dermatitis and infections at the implantation sites of the electrode/needle arraysdermatitis at the site of the generatorand patient syncope. A total of 1207 deviceseach producing up to 16 percutaneous puncturesfor a total of 19312 punctures were monitored for adverse effectsbased on retrospective chart audits conducted at 6 clinical facilities over a one-year period.Medical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 9, Pp 389-393 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	The peri-auricular percutaneous implantation of the Neuro-Stim System (NSS©) family of devices EAD© MFS© BRIDGE© (Innovative Health Solutions Versailles IN) is a non-opiate neuromodulation analgesic used for acute and chronic pain conditions. It is cleared as a minimal risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleeding localized dermatitis and infections at the implantation sites of the electrode/needle arrays dermatitis at the site of the generator and patient syncope. A total of 1 207 devices each producing up to 16 percutaneous punctures for a total of 19 312 punctures were monitored for adverse effects based on retrospective chart audits conducted at 6 clinical facilities over a one-year period. Medical technology R855-855.5
spellingShingle	The peri-auricular percutaneous implantation of the Neuro-Stim System (NSS©) family of devices EAD© MFS© BRIDGE© (Innovative Health Solutions Versailles IN) is a non-opiate neuromodulation analgesic used for acute and chronic pain conditions. It is cleared as a minimal risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleeding localized dermatitis and infections at the implantation sites of the electrode/needle arrays dermatitis at the site of the generator and patient syncope. A total of 1 207 devices each producing up to 16 percutaneous punctures for a total of 19 312 punctures were monitored for adverse effects based on retrospective chart audits conducted at 6 clinical facilities over a one-year period. Medical technology R855-855.5 Roberts A Sithole A Sedghi M Walker CA Quinn TM Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study
description	Arthur Roberts,1–3 Alec Sithole,4 Marcos Sedghi,5 Charles A Walker,6,7 Theresa M Quinn,8 1Indiana Craniofacial Center, 2Department of Oral Pathology, Medicine and Radiology, Indiana University School of Dentistry, Indianapolis, IN, USA; 3Department of Anesthesia, Critical Care, and Pain Management, College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, UK; 4Department of Computer Science, Mathematics and Physics, Missouri Western State University, St Joseph, MO, 5Conservative Care Specialists Medical Group, Los Angeles, CA, 6Walker Pain Management Center, Jackson, TN, 7Bethel University, Paris, TN, 8Wisconsin Pain Solutions, Menomonee Falls, WI, USA Abstract: The periauricular percutaneous implantation of the Neuro-Stim System™ family of devices EAD, MFS, and BRIDGE is a procedure involving the use of a non-opiate, neuromodulation analgesic for relieving acute and chronic pain. It has been approved as a minimal-risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleeding, localized dermatitis, and infections at the implantation sites of the electrode/needle arrays, dermatitis at the site of the generator, and patient syncope. A total of 1,207 devices, each producing up to 16 percutaneous punctures, for a total of 19,312 punctures were monitored for adverse effects, based on retrospective chart audits conducted at six clinical facilities over a 1-year period. Keywords: clinical risks and discomfort, percutaneous auricular neuro-stimulation, Neuro-Stim System™ devices, EAD, MFS, Bridge, neuromodulation, adverse effects
format	article
author	Roberts A Sithole A Sedghi M Walker CA Quinn TM
author_facet	Roberts A Sithole A Sedghi M Walker CA Quinn TM
author_sort	Roberts A
title	Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study
title_short	Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study
title_full	Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study
title_fullStr	Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study
title_full_unstemmed	Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study
title_sort	minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/3a767777e98a4c1a9c6046983d71db8f
work_keys_str_mv	AT robertsa minimaladverseeffectsprofilefollowingimplantationofperiauricularpercutaneouselectricalnervefieldstimulatorsaretrospectivecohortstudy AT sitholea minimaladverseeffectsprofilefollowingimplantationofperiauricularpercutaneouselectricalnervefieldstimulatorsaretrospectivecohortstudy AT sedghim minimaladverseeffectsprofilefollowingimplantationofperiauricularpercutaneouselectricalnervefieldstimulatorsaretrospectivecohortstudy AT walkerca minimaladverseeffectsprofilefollowingimplantationofperiauricularpercutaneouselectricalnervefieldstimulatorsaretrospectivecohortstudy AT quinntm minimaladverseeffectsprofilefollowingimplantationofperiauricularpercutaneouselectricalnervefieldstimulatorsaretrospectivecohortstudy
_version_	1718403132535341056

Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study

Ejemplares similares