(3T has severe limitations. NEVRO CORP. All questions or concerns about Nevro Corp. MR Unsafe:• You have a Nevro spinal cord stimulator • If you have any other medical device implants • A detailed description of your devices, including the product number of the implant, leads, and other implanted components • The contact information of. Product Manuals for Healthcare Professionals. V-6 or V-8 power. The patient is currently still using therapy and there have been no reports of further. Trade name. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Seroma (2069). We Believe True Innovation Transforms More Lives NEVRO CORP. Product Code Description Revenue Code HCPCS Code NIPG1000 or NIPG1500 or NIPG2500 IPG Kit 278 C1822 CHGR1000 or CHGR2500 Charger Kit 278 C1822 Most commercial plans provide guidance in their medical policies about which device HCPCS codes to report Nevro Senza Spinal Cord Stimulator ‐ MRI available Mon‐Fri, 8am‐5pm; Univ Hospital Only. 5T Highly Preferred. The risk of using other types of RF coils has not been evaluated. 5’ Patient Contact Material Titanium, Silicone rubber, Epoxy Product Specifications Product Specification SheetNEVRO CORP. 5/ 3-tesla closed, horizontal bore 15 min active scan time; must have all components out of head coil; stimulation off LEAD2008-xxB (extension), ACCK5xxx (lead anchor) and ACCK7000 (IPG port plug) MRSENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331) Event Date 08/06/2020: Event Type Injury Manufacturer Narrative The device was returned and analysis is currently in progress. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. All questions…The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331) Event Date 04/22/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. NIPG1500. It was reported to nevro that a patient had acquired an infection at the ipg pocket post implant. The. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). 1. NEVRO CORP. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel: +1. Please note that the following components of the Senza system are . (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has received CE Mark for full-body magnetic resonance imaging (MRI) conditional. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Death (1802); Pneumonia (2011). Nevro Corporation Senza Implantable Pulse Generator Users Manual. Nevro submits this report in compliance with fda's medical device reporting regulations under 21 cfr part 803. Model Number NIPG1500: Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191). 251. NEVRO CORP. Article Text. It was noted that the patient had a pre-existing condition that limited their mobility. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Aspiration/Inhalation (1725); Vomiting (2144) Event Date 08/09/2016:. It was reported to nevro that the patient¿s arm was making uncontrolled movements and the patient was hospitalized. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. Every person is unique and your. registered trademarks owned by Bluetooth SIG, Inc. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 11/15/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. 0005 Fax: +1. It was reported to nevro that the patient passed away due to complications from parkinson¿s disease. 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 Insufficient Information (4580) Event Date 08/01/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. 1800 Bridge Parkway Redwood City, CA 94065 USA 1. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. 15 Tesla and 3 Tesla Magnetic Resonance Imaging MRI Guidelines for the SENZA® SENZA II® SENZA Omnia™ Systems IPG1000 IPG1500 IPG2000 and IPG2500 ONLY 11096 Rev F 2 NEVRO…Nevro Corporation 1800 Bridge Parkway Redwood City, CA 94065: PMA Number: P130022: Supplement Number: S025: Date Received: 05/24/2019: Decision Date: 08/18/2019: Product Code:. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). Avoid activities that put stress on the implanted neurostimulation system components. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 07/21/2020: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. The battery lights will continue to flash. Senza HFX iQ is the first. Intended Purpose The IPG Kit consists of an implantable pulse generator which is a component of the Nevro Spinal Cord Stimulation System that is intended to aid in the management of chronic intractable pain of the trunk and/or limbs. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 12/17/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. , mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 06/26/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. It was reported to nevro that the patient developed an infection at the battery site. It was reported to nevro that the patient¿s incision site was not healing well and opening up. 1 Definitions of Terms • MR Conditional1: An item with demonstrated safety in the MR environment within defined conditions. 47909). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Skin Erosion (2075) Event Date 07/01/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. connect to the implan ted IPG. Manufacturer of the medical device. It is now the first spinal cord stimulator able to go into the strongest clinical. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Skin Erosion (2075) Event Date 07/01/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 01/30/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). , lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included. 5T or 3T transmit / receive RF head coil, as long as the implanted Nevro Senza system components are not within the transmit / receive. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 01/11/2021: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed and no issues were. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). The risk of using other types of RF coils has not been evaluated. The Senza system components will include: ď ˇ Implantable pulse generator (IPG) is a small, battery-powered electronic device that is implanted inside the body (see IPG in the diagram above). 1. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Arrhythmia (1721). Setup instructions, pairing guide, and how to reset. (Model Nos: NIPG1000 or NIPG1500). Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. At a minimum, address the conditions of the static magnetic field, the switched gradient magnetic field and NEVRO CORP. g. Manuals are subject to change; the most current version is available on this. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pocket Erosion (2013). NEVRO SPINAL CORD STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number NIPG1500: Device Problems Defective Device (2588); Material Deformation (2976); Therapeutic or Diagnostic Output Failure (3023) Patient Problem Failure of Implant (1924)NEVRO CORP. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. About Nevro Headquartered in Redwood City, California , Nevro is a global medical device company focused on providing innovative products that improve the quality of life of. Contact your Nevro HFX Care Team. NEVRO CORP. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. modello: MADP2008- xxB). products should be forwarded to: Nevro Corp. Dismiss the beeping by pressing and holding the ON/OFF Button for up to 5 seconds. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331) Event Date 03/12/2020: Event Type Injury Manufacturer Narrative Nevro is awaiting the return of the device. non. It was reported to nevro that the patient passed away. 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. During a routine call from a nevro representative, it was reported that a patient's device had been explanted due to infection. For this reason, always talk to your doctor if youThe Senza System has a very similar safety profile to other SCS devices that have been available for many years. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 01/01/2019: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. 9415 [email protected] or Model: NIPG1500. 650. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 12/01/2019: Event Type Injury Event Description It was reported that the patient's device was removed. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. NEVRO CORPORATION: Date Received: 2019-05-24:. Product Sizes: Size Type: N/S (NOT SPECIFIED) Dimension type for the clinically relevant measurement of the medical device. 00 per kit. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Skin Erosion (2075) Event Date 08/05/2019: Event Type Injury Manufacturer Narrative Nevro is awaiting the return of the device. Visit: IMRSER. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel:. 888. and a rechargeable, implantable pulse generator (I PG). NEVRO CORP. 1. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 02/08/2021: Event Type Death Manufacturer Narrative Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) : Patient Problem Skin Erosion (2075): Event Date 02/24/2021: Event Type Injury 11096 Rev F. The patient was hospitalized and the device was explanted. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Irritation (1941); Complaint, Ill-Defined (2331) Event Date 05/08/2020: Event Type Injury Manufacturer Narrative. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pneumonia (2011). NEVRO CORP. Catalog Number: NIPG1500. 10001162 Rev B 6 2. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Seizures (2063) Event Date 06/26/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to the nature of. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 04/13/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Primary DI Number:. (b)(6) determined a defective bracket that held the lead caused the spinal cord stimulator to malfunction, causing the stimulator to stop working. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 10/16/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Do not bring these. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Cardiac Arrest (1762) Event Date 08/05/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Nevro attempted to obtain additional information regarding the nature of the numbness but was unsuccessful. High roof or standard roof. 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 Reaction (2414) Event Date 06/28/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Impaired Healing (2378) Event Date 03/15/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature of the. 1. With respect to CRPS, I would be wary that the implant has less proven effectiveness than with actual spinal issues - my personal belief is that the CRPS my wife has may be neurological but NOT spinal. NEVRO CORP. The device was removed and there have been no reports of. 15, 2017 /PRNewswire/ - Nevro Corp. 9415 info@nevro. The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. Please note that MR Conditional components of the. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 04/10/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to the nature of. 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 Insufficient Information (4580) Event Date 01/11/2022: Event Type Injury Manufacturer Narrative. 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 Complaint, Ill-Defined (2331) Event Date 01/27/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. For example, the grantee code for FCC ID: XKYIPG1500 is XKY. 5’ x 15. NEVRO CORP. The safety of HFX has been thoroughly studied and proven. It was reported to nevro that the patient experienced numbness in the arm. Instead of worrying about how to relieve my pain. • You have a Nevro spinal cord stimulator • If you have any other medical device implants • A detailed description of your devices, including the product number of the implant,. Lead is a thin. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hematoma (1884) Event Date 09/20/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. Nevro attempted to obtain additional information regarding the nature of the incident but was unsuccessful. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Swelling (2091); Reaction (2414). Nevro has complied with regulatory investigation requirements and is submitting all. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. Contact Phone Extension: 6502510005: Phone Extension for the Customer contact. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Arrhythmia (1721). Component Model Number(s) Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000 Nevro Percutaneous Leads LEAD10x8-xx(B) Lead Extensions LEAD2008-xx(B) Lead Anchors All models (ACCK5000, ACCK5101, ACCK5200, ACCK5300) NEVRO CORP. Nevro attempted to obtain additional information regarding the nature of the device removal but none was available. Expanding Patient Access to Nevro's HF10® Therapy Through Broader Imaging Compatibility Nevro Corp. Sign in to add this product to your favorites! Price: $3,530. 2015. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Convulsion/Seizure (4406) Event Date 01/10/2022: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 05/09/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Product Manuals for Healthcare Professionals. View All. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 01/13/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). Important safety, side effects, and risks information. 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 Unspecified Infection (1930) Event Date 06/12/2020: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 07/16/2020: Event Type Death Manufacturer Narrative A review of the complaint database has found no other instances of similar. 187. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Myocardial Infarction (1969); Cancer (3262). The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. Die Bluetooth®-Wortmarke und -Logos sind eingetragene Marken von Bluetooth SIG, Inc. NEVRO CORP. It was reported to nevro that during an implant procedure, an orange liquid was observed coming from the patient's mouth. 2 NEVRO CORP. MR Unsafe:Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 07/20/2016: Event Type Injury Manufacturer Narrative. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Skin Erosion (2075); Pressure Sores (2326) Event Date 02/03/2022: Event Type Injury Manufacturer Narrative. 251. The manufacturing records were reviewed and no relevant nonconformities were found. NEVRO SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results:. There were no reports of device-related issues from the patient prior to the passing. The device was ultimately removed due to patient non-compliance and the physician was. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. The manufacturing records were reviewed and no relevant nonconformities were found. NEVRO CORP. 5 cycle of Nevro SCS system requires continued voltage variations operation during power mains interruptions, it is on power supply 40 % UT 40 % UT recommended that the Nevro SCS system be input lines IEC (60 % dip in UT) (60 % dip in UT) powered from an uninterruptible power supply or 61000-4. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Tatevossian and Defendant Greg Khouganian, M. Sign in to add this product to your favorites! Price: $3,530. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hypersensitivity/Allergic reaction (1907). It was reported to nevro during a patient's follow up that a patient had acquired an infection 4 months post implant. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). Tel: +1. The remaining characters of the FCC ID, IPG1500, are often associated with the product model, but they can be random. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Seizures (2063) Event Date 10/15/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed, and no non-conformities were. a different manufacturer attached to the Nevro IPG. Use only product literature from the region where the patient procedure was performed. The Leads are for single use and interface with the IPG, Lead Extensio ns, OR Cable, and lead accessories. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 09/10/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed, and no non-conformities were. On September 17, 2017, based on the representations of Dr. I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. On September 17, 2017, based on the representations of Dr. One comprehensive solution for individualized relief of chronic pain that gives you more versatility than ever before. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). NEVRO CORP. Nevro has complied with regulatory investigation requirements and is submitting. Figure 1: Head MRI scans are permissible using 1. Preliminary, unaudited second quarter 2021 U. Nevro had attempted to obtain additional information regarding the nature of the issue but was unsuccessful. 47909). NEVRO CORP. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. S. The patient was hospitalized and was given iv antibiotics. It was reported to nevro that the patient had the device removed. Read. NEVRO CORP. Notable features in 2015: New SL trim level for cargo van. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). 5T Highly Preferred. Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns. Catalog Number: NIPG1500 Company Name: NEVRO CORP. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. Anesthesiology, 123(4) 2 Kapural L. 5T closed bore scanners subject to conditions in the MRI Procedures Manual. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Scar Tissue (2060); Spinal Cord Injury (2432) Event Date 07/08/2020:NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 12/29/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. The medical device 1500 IPG NEUROSIS WITHOUT is realized by NEVRO CORP. 251. (b)(6) determined a defective bracket that held. View 2015 model details Shop Now. , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. The risk of using other types of RF coils has not been evaluated. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 10/23/2020: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. It is implanted under the skin and has an inbuilt battery. NEVRO CORP. Some spinal cord stimulators are safe for an MRI, but others aren’t. Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR. . SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 01/15/2022: Event Type Death Event Description It was reported that the patient passed away. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Stroke/CVA (1770) Event Date 06/25/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. B Seite 5. Device Name: Senza® IPG Kit. It was reported to nevro that the patient was in a rehabilitation facility. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Wound Dehiscence (1154) Event Date 10/09/2019: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed and no issues related to the. YOU ARE ABOUT TO EXIT FOR A WEBSITE INTENDED FOR THE RESIDENTS OF ANOTHER COUNTRY OR REGION. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Wound Dehiscence (1154) Event Date 01/24/2022: Event Type Injury Event Description It was reported that a patient was experiencing wound dehiscence issue. Other trademarks and trade names are those of their respective owners. Nevro SCS3 Perc. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 12/18/2021: Event Type Injury Event Description It was reported that the patient was admitted to the icu. A spinal cord stimulator system is made of four parts: Impulse Generator (IPG): this is a computer that is roughly the size of a matchbox that controls the impulses delivered to the spinal cord. NEVRO CORP. PRECAUTIONS. For Trial Patients (TSM3000/TSM3500) How to Use Your Trial Device Your Nevro HFX Care Team Contact Information Please call 1-844-331-1001About Nevro Headquartered in Redwood City, California , Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. NEVRO CORP. The manufacturing records were reviewed and no relevant nonconformities were found. Manuals are subject to change; the most current version is available on this page. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Skin Erosion (2075) Event Date 08/08/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to the nature of. NEVRO CORP. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD1058-xx(B): LEAD1058-50(B), LEAD1058-70(B),AccessGUDID - Nevro® (00813426020251)- N300 Lead Anchor Kit. Please note that product literature varies by geography. One comprehensive solution for individualized relief of chronic pain that gives you more versatility than ever before. a different manufacturer attached to the Nevro IPG. Due Apr 24, 2018. The patient received physical therapy and regained their leg function. 650. NEVRO CORP. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. Resources for radiology and pain management clinicians whose patient has a Medtronic spinal cord stimulation system and requires an MRI scan. 356. Search Alerts/Recalls. , lumbar, truncal, in a limb). 356. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pain (1994) Event Date 08/12/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 01/03/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. However, we may not have been able to confirm this information. The Senza and Senza II Systems are implantable systems and deliver stimulation using implantable leads. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); Sepsis (2067) Event Date 06/12/2019: Event Type Injury Manufacturer Narrative. On September 17, 2017, based on the representations of Dr. Nevro attempted to obtain a medical assessment regarding the nature of the issue, but none was available. UserManual. Please note that the following components of the Senza system are . The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). There were no reports of device-related issues from the patient prior to the incident. HFX Spinal Cord Stimulation is a nondrug, FDA-approved, treatment option for long-term chronic pain relief. It was reported to nevro that the patient was hospitalized for seizures. Many of the Nevro HFX spinal cord stimulator reviews mention the lasting relief it has provided after decades of chronic pain. 251. The patient continues to use their device with effective pain relief. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 06/06/2020: Event Type Death Manufacturer Narrative The date of death is estimated based on diagnostic data provided. 1500 IPG NEUROSIS WITHOUT. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 02/01/2019: Event Type Death Manufacturer Narrative A review of the complaint record has found no other instances of similar events. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. The Senza syste m components will include: Implantable pulse generator (IPG) is a small, battery-powered electronic device that is implanted. NEVRO CORP. Physician Implant. It was reported to nevro that the patient experienced a hemorrhage requiring surgical intervention. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Death (1802); Cancer (3262) Event Date 01/05/2021: Event Type Injury Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. Please note that the following components of the Senza system are . 0005 . The physician believes the cause of death was pneumonia and not device related. There were no reports of device-related issues from the patient prior to the passing. The device was explanted. MR Unsafe:AccessGUDID - Omnia (00813426020572)- Senza Omnia IPG Kit An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). Certain Abbott neurostimulation systems are MR Conditional with 1. NEVRO CORP. 251. NEVRO CORP. 251. 650. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pain (1994) Event Date 09/23/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. All questions or concerns about Nevro Corp. It was reported to nevro that the patient acquired an infection and had the device removed. Use only product literature from the region where the procedure was performed. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Burning Sensation (2146); Reaction (2414); Electric Shock (2554). During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. Dismiss the beeping by pressing and holding the ON/OFF Button for up to 5 seconds. Please note that the following components of the Senza system are . SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 07/27/2020: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. It was reported to nevro that the patient acquired an infection at the pocket site. Nevro has complied with regulatory investigation requirements and is submitting all information. inside the body (see IPG in the diagram above). Nevro has complied with regulatory investigation requirements and is submitting all information. The Chronic Pain Solution The sum of excellence in four key. The physician believes this was due to being a smoker and non-compliance with. MR Unsafe: Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xxB: LEAD1058-50B, LEAD1058-70B, LEAD1058-90B Surpass® Surgical Lead LEAD3005-xxB: LEAD3005-50B, LEAD3005-70B, LEAD3005-90B Surpass-C™ Surgical Lead LEAD2005-xxB: LEAD2005-50B, LEAD2005-70B, LEAD2005-90B Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD1058-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) Surpass-C™ Surgical Lead LEAD2005-xxB: LEAD2005-50B, LEAD2005-70B, LEAD2005-90B then use the patient ID card to identify Nevro Corp as the manufacturer of the patient’s spinal cord stimulator system. com MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian Sponsor Emergo Asia Pacific Pty Ltd Nevro SENZA®, SENZA II® and SENZA Omnia™ Spinal Cord Stimulation (SCS). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pneumonia (2011). NIPG1500: Device Catalogue Number. com MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian Sponsor Emergo Asia Pacific Pty Ltd Expanding Patient Access to Nevro's HF10® Therapy Through Broader Imaging Compatibility Nevro Corp. Request A Paper Manual. Sign in to add this product to your favorites! Price: $3,530. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. All questions or concerns about Nevro Corp. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. Nevro Corp. HFX has a similar safety profile, including side effects and risks, to other. Redwood City, CA 94065 USA . ACCK8012-90 Central nervous system electrical stimulation system lead stylet Primary: 00813426020800 4f637b5f-6a9b-47ab-9590-27e6d809f553 Nevro® 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 Insufficient Information (4580) Event Date 06/01/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. It was reported to nevro that the patient was hospitalized. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. NEVRO CORP. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Fall (1848); Muscle Weakness (1967).