Neurostimulation System: Senza Spinal Cord Stimulation System. On (b)(6) 2018 stimulator was not working properly, dr. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. NEVRO CORP. Einführung Das Senza-Rückenmarkstimulationssystem (Spinal Cord Stimulation System, SCS-System) von Nevro ist ein bedingt MR-sicheres (MR Conditional) Produkt, das in einem festgelegten MRT-Umfeld bei Einhaltung bestimmter Richtlinien gemäß. 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. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pneumonia (2011). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Complaint, Ill-Defined (2331); Insufficient Information (4580). NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. 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. 47909). (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that full-body magnetic resonance imaging (MRI) conditional labeling is now. The medical device 1500 IPG NEUROSIS WITHOUT is realized by NEVRO CORP. Nevro attempted to obtain additional information regarding the nature of the issue but none was available. It was reported to nevro that the patient passed away. 2. NEVRO CORP. The physician noted that the patient has a pre-existing autoimmune disease making her more susceptible to. NEVRO CORP. Category Name: NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE: Category Code: J020202: Sign repertoire: Registered: Group of similar. NEVRO CORP. Nevro attempted to obtain a medical assessment from a healthcare professional but no additional information was available. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). NEVRO CORP. Nevro Corporation. There were no reports of device-related issues from the patient prior to the incident. PRECAUTIONS. It was reported to nevro that the patient experienced spasms following the implant procedure. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. Dismiss the beeping by pressing and holding the ON/OFF Button for up to 5 seconds. THE List. Expired » Nevro » Neuromodulation. V-6 or V-8 power. 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 Death (1802) Event Date 01/30/2019: 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. 47909). Please note that the following components of the Senza system are . Photos are for illustration purposes only and may not depict the exact item. , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. 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. ď ˇ Lead, instead of connecting to an external stimulator as occurred during the trial phase, will connect to the implanted IPG. Product Manuals for Healthcare Professionals. 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. Please note that the following components of the Senza system are . Device Name: Senza® IPG Kit. Manuals are subject to change; the most current version is available on this. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). 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 01/31/2022: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. The IPG is. Nevro hereby declares that the SENZA®, SENZA II®, SENZA Omnia™ is in compliance with the essential. 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. Tatevossian and Defendant Greg Khouganian, M. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel: +1. 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 03/15/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. (b)(6) determined a defective bracket that held. The report also indicated that the patient is immuno-suppressive due to a kidney transplant. 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. 9415 [email protected] or Model: NIPG1500. High roof or standard roof. 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. Senza HFX iQ is the first. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). 0005 . Primary ID,Brand Name,Company Name,Version or Model,GMDN Terms,Device ID a35b370b-b73b-44e1-a121-dbdfa7a48be9,Nevro® ,NEVRO CORP. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. 0005 Fax: +1. NEVRO CORP. Certain Abbott neurostimulation systems are MR Conditional with 1. Some spinal cord stimulators are safe for an MRI, but others aren’t. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. 47909). It was reported to nevro during a patient's follow up that a patient had acquired an infection 4 months post implant. These letters are chosen by the applicant. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Myocardial Infarction (1969); Cancer (3262). NEVRO CORP. 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 Skin Erosion (2075) Event Date 02/24/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. 5 cycle for 0. . The risk of using other types of RF coils has not been evaluated. “Now I have an active lifestyle for the first time since I was in my 30s. 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 Death (1802) Event Date 05/09/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non- Conflict of Interest: Dawood Sayed serves as a consultant to Abbott, Boston Scientific, Flowonix, Medtronic, Nevro, PainTEQ, SPR Therapeutics, Vertos, and Vertiflex. Global Unique Device ID: 00813426020015. 00 per kit. 0 million, an increase of 67% compared to $51. It was reported to nevro that during an implant procedure, an orange liquid was observed coming from the patient's mouth. We Believe True Innovation Transforms More Lives NEVRO CORP. Introduction Nevro® SENZA®, SENZA II®, and SENZA Omnia™ Spinal Cord Stimulation (SCS) systems are MR Conditional devices that have been demonstrated to present no known hazards in a specified MR environment when following specific guidelines as described in this document. Typically safer than other spine surgeries used to address chronic pain 1-5. The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. s28. 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 available diagnostic data showed no indications of a device. 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. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. The manufacturing records were reviewed and no relevant nonconformities were found. and a rechargeable, implantable pulse generator (I PG). Use only product literature from the region where the procedure was performed. 2 NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 06/22/2016: Event Type Injury Manufacturer Narrative. 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. 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. 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 08/06/2021: 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). 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. (b)(6) determined a defective bracket that held the lead caused the spinal cord stimulator to malfunction, causing the stimulator to stop working. Posted Mar 21, 2018. The Chronic Pain Solution The sum of excellence in four key. 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. Component Model Number(s) Nevro IPG(s) NIPG1000,. 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. 650. These letters are chosen by the applicant. NEVRO CORP. Trade name. a different manufacturer attached to the Nevro IPG. 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 01/19/2021: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed and no issues were. NEVRO CORP. Cargo or 12-seat passenger 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). Nevro attempted to obtain a medical assessment from a healthcare professional to confirm the cause of death but no additional information was available. Sign in to add this product to your favorites! Price: $3,530. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Movement Disorder (4412) Event Date 03/04/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. NEVRO CORP. Sign in to add this product to your favorites! Price: $3,530. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. Brand Name: Senza® . Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. Nevro and the specialist have been notably quieter since it was clear the implant was not a 'very' successful one, but they are still supportive. 5’ x 15. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pneumonia (2011). It is implanted under the skin and has an inbuilt battery. Get your discussion guide to start a conversation with your doctor. Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). 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. 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. 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. The risk of using other types of RF coils has not been evaluated. Follow up report indicated that the infection has cleared and the patient had recovered without sequelae. Please note that product literature varies by geography. 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. 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. Nevro Corp. Federal Contract Opportunity for Neurostimulator Products N0025918N0060. 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. NEVRO CORP. Nevro attempted to obtain additional information regarding the nature of the issues, but. Please note that MR Conditional components of the Senza system do not include The trial stimulator (TSM), patient remote, charger, surgical accessories, programmer wand, and clinician programmer. org. Please note that the following components of the Senza system are . It was reported to nevro that the patient experienced numbness in the arm. Visit: IMRSER. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System, Neuromodulation System. 1800 Bridge Parkway Redwood City, CA 94065 USA 1. For example, the grantee code for FCC ID: XKYIPG1500 is XKY. 5T or 3T transmit / receive RF head coil, as long as the implanted Nevro Senza system components are not within the transmit / receive. I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. NEVRO CORP. The. Minimal restrictions and reversible. 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. The device was removed and the patient was discharged and is currently recovering. There were no reports of device-related issues from the patient prior to the passing. NEVRO CORP. Catalog Number: NIPG1500 Company Name: NEVRO CORP. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-• 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 componentsNevro’s system is the only device on the market that should be billed with C ô î î. 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. Primary DI Number: 00813426020015 Issuing Agency: GS1 Commercial Distribution End Date: Device Count:. Instead of worrying about how to relieve my pain. NEVRO CORP. Manufacturer of the medical device. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. 187. Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). NIPG1500. Nevro attempted to obtain additional information regarding the nature of the hospitalization but was unsuccessful. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Stroke/CVA (1770); Seizures (2063). Tatevossian and Defendant Greg Khouganian, M. 0005 The Senza System has a very similar safety profile to other SCS devices that have been available for many years. NEVRO CORP. 251. Notable features in 2015: New SL trim level for cargo van. The Senza and Senza II Systems are implantable systems and deliver stimulation using implantable leads. NIPG1000 Analgesic spinal cord electrical stimulation system (36007) Primary: 00813426020008 36007 Obsolete False 10b480bc-7cc2-4ec1-b41a. Surgery on (b)(6) 2018 for the removal of lead, battery, and bracket and replacement of lead. The remaining characters of the FCC ID, IPG1500, are often associated with the product model, but they can be random. NEVRO CORP. D. NEVRO CORP. Category Name. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. q4cdn. Nevro attempted to obtain additional information regarding the nature of the numbness but was unsuccessful. Many of the Nevro HFX spinal cord stimulator reviews mention the lasting relief it has provided after decades of chronic pain. 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 02/28/2020: Event Type Death 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 Problems Wound Dehiscence (1154); Unspecified Infection (1930) Event Date 10/22/2019: Event Type Injury Manufacturer Narrative. Primary ID Brand Name Company Name Version or Model GMDN Terms Device ID a0379068-a2f1-41ec-887e-bf4cb73dbeaa Nevro® NEVRO CORP. Nevro Senza Spinal Cord Stimulator ‐ MRI available Mon‐Fri, 8am‐5pm; Univ Hospital Only. All questions…Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). 650. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Foreign Body Reaction (1868) Event Date 02/10/2021: 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 Unspecified Kidney or Urinary Problem (4503) Event Date 03/29/2023: Event Type Death Event Description It was reported that the patient passed away due to. NEVRO CORP. , lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included. products should be forwarded to: Nevro Corp. Nevro is awaiting the return of the device. Primary DI Number:. 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. 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). 1500 IPG NEUROSIS WITHOUT. NEVRO CORP. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hypersensitivity/Allergic reaction (1907). Neurostimulation System: Senza Spinal Cord Stimulation System. The safety of HFX has been thoroughly studied and proven. 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. , et al. 251. 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. 5’ Patient Contact Material Titanium, Silicone rubber, Epoxy Product Specifications Product Specification SheetNEVRO CORP. Nevro >. 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. Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. 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 01/01/2019: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. 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 06/05/2020: 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 07/21/2020: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. 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. This Reimbursement Guide is an interactive PDF covering the common questions and barriers of reimbursement including the following sections: Coverage – Includes a Medicare Coverage Map and details on requirements of psychological evaluations and surgical consultations. The report indicated that the patient has a history of (b)(6) and was diagnosed with acute kidney. Nevro Corp. ‐ Low SAR mode; SAR set based on device instructions. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Death (1802); Pneumonia (2011). Federal Contract Opportunity for Nevro Corps IPG Kit N0025918N0050. 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 02/08/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. The device was removed and there have been no reports of. 650. 650. 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. products should be forwarded to: Nevro Corp. I am. Redwood City, CA 94065 USA . 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 08/03/2022: Event Type Death Event Description It was reported that the patient passed away. NEVRO CORP. NEVRO CORP. It was reported to nevro that the patient passed away due to complications from parkinson¿s disease. 5 Tesla. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 . Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802). The physician believes the cause of death was pneumonia and not device related. HFX™ for PDN Now the Only Spinal Cord Stimulation System Approved by FDA to Treat PDN¹ Company Will Immediately Initiate Commercial Launch Activities in the U. Lead, instead of connecting to an external stimulator as occurred during the trial phase, will. 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. Nevro has complied with regulatory investigation requirements and is submitting all information. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. NEVRO CORP. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility REDWOOD CITY, California , Nov. 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. 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 10/23/2018: Event Type Death Manufacturer Narrative The device was returned and analyzed. Mode of MR operation in which none of the outputs have a value that may cause physiological stress to patients (2 W/kg whole body SAR, 3. Many of the Nevro HFX spinal cord stimulator reviews mention the lasting relief it has provided after decades of chronic pain. 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. Important safety, side effects, and risks information. NEVRO CORP. The patient was hospitalized and was given iv antibiotics. 0005 1. The leads were left in-situ for future reimplant. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Contact your Nevro HFX Care Team. 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 08/03/2016: Event Type Injury Manufacturer Narrative The device was not explanted. If the user interruptions and for 0. 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. Nevro has complied with regulatory investigation requirements and is submitting. 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 attempted to obtain additional information regarding the nature of the surgery but was. 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-IPG NIPG1000, NIPG1500, NIPG2000, NIPG2500SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Electric Shock (2554) Event Date 07/03/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to the nature of. Nevro has complied with regulatory investigation requirements and is submitting all information. NEVRO CORP. 00 per kit In Stock: 0 kits: Status: expired:NEVRO CORP. NEVRO CORP. Photos are for illustration purposes only and may not depict the exact item. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG. 3876 Nevro. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Muscle Spasm(s) (1966). Manufacturer of the medical device. NEVRO CORP. 2 NEVRO CORP. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. 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. 15, 2017 /PRNewswire/ - 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 CORP. NEVRO SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results:. products, including any serious incident that has occurred in relation to the device, should be forwarded to: Nevro Corp. 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 10/28/2019: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed and no issues were. I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. 1 Definitions of Terms • MR Conditional1: An item with demonstrated safety in the MR environment within defined conditions. The manufacturing records were reviewed and no relevant nonconformities were found. Learn more about HFX iQ. then use the patient ID card to identify Nevro Corp as the manufacturer of the patient’s spinal cord stimulator system. Nevro Corporation. We would like to show you a description here but the site won’t allow us. 356. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. Nevro has complied with regulatory investigation requirements and is submitting all. All questions or concerns about Nevro Corp. Safety Topic / Subject. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Myocardial Infarction (1969) Event Date 08/17/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. It was reported to nevro that the patient passed away due to complications from pneumonia. 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. Manuals are. HFX iQ is a smart pain management system that uses the largest clinical SCS dataset to recommend the starting program most likely to provide pain relief 1 and adjusts therapy based on each patient's responses to maintain optimized relief. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Nausea (1970); Seizures (2063). The IPG is implanted in a subcutaneous pocket. I componenti MR Conditional del sistema Senza . Contact your Nevro HFX Care Team. The device was explanted. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. 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 Death (1802) Event Date 10/22/2019: Event Type Death Manufacturer Narrative The device was not returned. IMPORTANT: Do not change or modify any component of the Nevro® Senza system, unless expressly approved by Nevro Corp. (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD1058-xx(B): LEAD1058-50(B), LEAD1058-70(B), LEAD1058-90(B) Surpass™. There were no reports of device-related issues from the patient prior to the passing. It is now the first spinal cord stimulator able to go into the strongest clinical. 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 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. g. Do not bring these. S. It was reported to nevro that the patient was hospitalized for seizures. 1. found. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals.