Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) : Patient Problem Death (1802): Event Date 01/30/2021: Event Type Death Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). , lumbar, truncal, in a limb). , 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 Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); Pocket Erosion (2013) Event Date 01/28/2021: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 09/09/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. Good News! Based on your survey responses, Nevro HFX TM could relieve your chronic pain. Primary ID,Brand Name,Company Name,Version or Model,GMDN Terms,Device ID a35b370b-b73b-44e1-a121-dbdfa7a48be9,Nevro® ,NEVRO CORP. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. modello: MADP2008- xxB). Preliminary, unaudited second quarter 2021 U. Use only product literature from the region where the patient procedure was performed. It was reported to nevro that the patient passed away due to complications from pneumonia. It was reported to nevro that the patient was hospitalized for seizures. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Seroma (2069). Nevro attempted to obtain additional information regarding the nature of the incident but was unsuccessful. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. Some spinal cord stimulators are safe for an MRI, but others aren’t. Nevro has complied with regulatory investigation requirements and is submitting all. We Believe True Innovation Transforms More Lives NEVRO CORP. I am. Expanding Patient Access to Nevro's HF10® Therapy Through Broader Imaging Compatibility Nevro Corp. The device was removed and the patient was discharged and is currently recovering. HFX has a similar safety profile, including side effects and risks, to other. 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 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. The physician stated that there was no infection and no antibiotics were given to the patient. 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’s Senza Spinal Cord Stimulation (SCS) system is an MR. Nevro attempted to obtain additional information regarding the nature of the hospitalization but was unsuccessful. See. 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. 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 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 Death (1802) Event Date 01/13/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. 3876 Nevro. Nevro attempted to obtain more information regarding the nature of the issue, but none was available. NEVRO CORP. ‐ 1. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has received approval from the U. 650. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. NEVRO CORP. 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. D. 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. Nevro submits this report in compliance with fda's medical device reporting regulations under 21 cfr part 803. Federal Contract Opportunity for Neurostimulator Products N0025918N0060. Product Sizes: Size Type: N/S (NOT SPECIFIED) Dimension type for the clinically relevant measurement of the medical device. 5T Highly Preferred. UserManual. 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. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System, Neuromodulation System. 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. It was reported to nevro that during an implant procedure, an orange liquid was observed coming from the patient's mouth. 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 03/31/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. There were no reports of device-related issues from the patient prior to the passing. 0 million, an increase of 67% compared to $51. The manufacturing records were reviewed and no issues were found related to the nature of the complaint. 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. 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. 47909). It was reported to nevro that the patient¿s incision site was not healing well and opening up. 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. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Nevro attempted to obtain a medical assessment from a. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Hypertension (4460). 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. Nevro Corp. 251. The physician believes this was due to being a smoker and non-compliance with. 0 million in the prior. Redwood City, CA 94065 USA . 1 Definitions of Terms • MR Conditional1: An item with demonstrated safety in the MR environment within defined conditions. comSENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Inadequate Pain Relief (2388); Insufficient Information (4580) Event Date 03/01/2022: Event Type Injury Event Description It was reported that the patient's device was removed. It was noted that the patient had a pre-existing condition that limited their mobility. Nevro is awaiting the return of the device. Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). 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 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. (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. Please note that the following components of the Senza system are . “Now I have an active lifestyle for the first time since I was in my 30s. 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. It’s a small device, placed in a same-day, outpatient procedure, that safely works inside your body to significantly reduce your pain and restore your quality of. It was reported to nevro that the patient was in a rehabilitation facility. Primary DI Number:. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. Anesthesiology, 123(4) 2 Kapural L. 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). 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. It was reported to nevro that the patient experienced a hemorrhage requiring surgical intervention. 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 Death (1802) Event Date 05/09/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Catalog Number: NIPG1500 Company Name: NEVRO CORP. g. Tatevossian and Defendant Greg Khougarnian, M. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Wound Dehiscence (1154); Impaired Healing (2378). The IPG is. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). NEVRO CORP. NEVRO CORP. (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 available in the United States for the Senza Spinal Cord Stimulation. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. Prima di eseguire o raccomandare un esame MRI su un paziente con il sistema Nevro Senza SCS, è importante leggere interamente questo documento. 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 Problem Seizures (2063) Event Date 10/15/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed, and no non-conformities were. It was reported to nevro that the patient's device was removed due to an emergency upper back surgery. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Complaint, Ill-Defined (2331); Insufficient Information (4580). 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 01/29/2022: Event Type Death Event Description It was reported that the patient passed away. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. 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 07/27/2020: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. There were no reports of device-related issues from the patient prior to the passing. 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. 1800 Bridge Parkway . Manufacturer of the medical device. non. S. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). 1500 IPG NEUROSIS WITHOUT. 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 Death (1802) Event Date 05/28/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. It was reported to nevro that the patient was hospitalized. 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. 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. NEVRO CORP. Nevro has complied with regulatory investigation requirements and is submitting. 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. Brand Name: Senza® . SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Complaint, Ill-Defined (2331); Inadequate Pain. The device was explanted. It was reported to nevro that the patient experienced spasms following the implant procedure. It was reported to nevro that the patient passed away due to complications from parkinson¿s disease. . NEVRO CORP. We would like to show you a description here but the site won’t allow us. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Embolism (1498) Event Date 01/24/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). The Senza Spinal Cord Stimulation (SCS) system is an implanted, rechargeable spinal cord stimulation system intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to. and is capable of stimulating the spinal cord nerv es when used with one or more leads. 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 Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Scar Tissue (2060); Spinal Cord Injury (2432) Event Date 07/08/2020:NEVRO CORP. 650. The medical device 1500 IPG NEUROSIS WITHOUT is realized by NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Muscle Spasm(s) (1966). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). 11096 Rev F. Surgery on (b)(6) 2018 for the removal of lead, battery, and bracket and replacement of lead. 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. For example, the grantee code for FCC ID: XKYIPG1500 is XKY. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG. 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 the doctor who implanted your device Nevro Corp. It was reported to nevro that the patient¿s arm was making uncontrolled movements and the patient was hospitalized. The report also indicated that the patient is immuno-suppressive due to a kidney transplant. Due Apr 24, 2018. and any use of such marks by Nevro Corp. HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment of chronic pain. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Paralysis (1997); Numbness (2415). 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 12/29/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. Figure 1: Head MRI scans are permissible using 1. Contact your Nevro HFX Care Team. 1 Kapural L. Trade name. NEVRO CORP. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xxB: LEAD1058-50B, LEAD1058-70B, LEAD1058-90B Surpass® Surgical. Approval For A Change In The Approved Packaging For The IPG (NIPG1500, NIPG2000), Lead Extension Kits (MADP2008-25B M8, SADP2008-25B S8), And Lead Adapter Kits (LEAD2008-25B, LEAD2008-35B, LEAD2008-60B) Of Your Senza Spinal Cord Stimulation (SCS) System. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site. Nevro attempted to obtain additional information regarding the nature of the issues, but. 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 Stroke/CVA (1770) Event Date 06/25/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. An electrode: this sits in the epidural space and delivers very small and precise currents. The battery lights will continue to flash. It was noted that the patient had been using the device with effective pain relief. On September 17, 2017, based on the representations of Dr. 888. The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. items on this form include forced-choice terms used by the fda for reporting purposes that do not necessarily reflect nevro¿s conclusions about the causes or nature of the event. 251. NIPG1500: Device Catalogue Number. 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. Instead of worrying about how to relieve my pain. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. 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. 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 10/01/2021: Event Type Death Manufacturer Narrative The date of death is an estimate based on information reported. It was reported to nevro that the patient passed away. Minimal restrictions and reversible. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. THE List. 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. CE Mark effective on 4 May 2010 . 5 Tesla. NEVRO CORP. Company Name: 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 02/01/2019: Event Type Death Manufacturer Narrative A review of the complaint record has found no other instances of similar events. 5T closed bore scanners subject to conditions in the MRI Procedures Manual. 0005 Fax: +1. 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. 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. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. (Model Nos: NIPG1000 or NIPG1500). Primary DI Number: 00813426020015 Issuing Agency: GS1 Commercial Distribution End Date: Device Count:. 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. Nevro has complied with regulatory investigation requirements and is submitting all. 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 09/28/2018: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. These letters are chosen by the applicant. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Fall (1848); Muscle Weakness (1967). 9415 [email protected] or Model: NIPG1500. NEVRO CORP. That was certainly the case for Bryant, whose chronic debilitating back pain often made it impossible for him to do his job as a computer repairman. 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 03/07/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 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. Primary ID Brand Name Company Name Version or Model GMDN Terms Device ID f417ce9f-5817-4688-b496-446369dcbd82 Senza 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. NEVRO CORP. There were no reports of device-related issues from the patient prior to the. 3 Million and Plans to Update Guidance When It Reports Second Quarter 2021 Financial Results on August 4, 2021 Nevro Corp. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8. s28. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. HF 10 SENZA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number NIPG1500: Device Problem Unexpected Therapeutic Results (1631) Patient Problems Pain (1994); Swelling (2091) Event Date 11/15/2019: Event Type Injury Event Description. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has received approval from the U. NEVRO CORP. Now Available, FDA-Approved, Artificial Intelligence-based HFX iQ™. On (b)(6) 2018 stimulator was not working properly, dr. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Spinal Cord Injury (2432). 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 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 Death (1802) Event Date 10/03/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. ď ˇ Lead, instead of connecting to an external stimulator as occurred during the trial phase, will connect to the implanted IPG. 15, 2017 /PRNewswire/ - Nevro Corp. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. Please note that the following components of the Senza system are . Component Model Number(s) Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xx(B): LEAD1058-50(B), LEAD1058-70(B), LEAD1058-90(B) Surpass™ Surgical Lead LEAD3005-xx(B): LEAD3005-50(B), LEAD3005-70(B), LEAD3005-90(B) Lead Anchors All models (ACCK5000,. (NYSE: NVRO), a. Product Code. Certain Abbott neurostimulation systems are MR Conditional with 1. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). 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 01/27/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. It was reported to nevro that a patient in (b)(6) had acquired an infection following a revision procedure. 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. The remaining characters of the FCC ID, IPG1500, are often associated with the product model, but they can be random. Die Bluetooth®-Wortmarke und -Logos sind eingetragene Marken von Bluetooth SIG, Inc. is under license. NEVRO CORP. NEVRO CORP. NEVRO CORP. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. HFX has a similar safety profile, including side effects and risks, to other. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802). ACCK8012-70 Central nervous. registered trademarks owned by Bluetooth SIG, Inc. During a routine call from a nevro representative, it was reported that a patient had acquired an infection post implant. On (b)(6) 2018 stimulator was not working properly, dr. NEVRO CORP. Contact your Nevro HFX Care Team. Product Manuals for Patients. and a rechargeable, implantable pulse generator (I PG). One comprehensive solution for individualized relief of chronic pain that gives you more versatility than ever before. 1500 IPG NEUROSIS WITHOUT. NEVRO CORP. Nevro has complied with regulatory investigation requirements and is submitting all information. 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. , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. NEVRO CORP. 187. The risk of using other types of RF coils has not been evaluated. 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 Skin Erosion (2075) Event Date 07/01/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. Posted by the Bureau of Medicine and Surgery (DOD - Navy). NEVRO CORP. Nevro attempted to obtain additional information regarding the nature of the infection, but none was available. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Embolism (1498) Event Date 01/24/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. Global Unique Device ID: 00813426020015. Follow up report indicated that the infection has cleared and the patient had recovered without sequelae. The battery lights will continue to flash. Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. Every person is unique and your medical needs differ from those of others, even people with the same condition and the same SCS system. Manufacturer of the medical device. It was reported to nevro that a patient had acquired an infection following a permanent implant. 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. 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. The Chronic Pain Solution The sum of excellence in four key. NIPG1500. The manufacturing records were reviewed and no relevant nonconformities were found. 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 06/24/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. 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 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. Posted Mar 21, 2018. It is implanted under the skin and has an inbuilt battery. 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. Use only product literature from the region where the patient procedure was performed. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. (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. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Implant Pain (4561) Event Date 01/25/2022: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. found. Important safety, side effects, and risks information. SENCO NEVRO HF-10 "SCS" STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number NIPG1500: Device Problems Energy Output Problem (1431);. 5. 1. S. q4cdn. Device Name: Senza® IPG Kit. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel:. 356. 251. There were no reports of device-related issues from the patient prior to the passing. NEVRO CORP. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. However, we may not have been able to confirm this information. Complete the form below so a Nevro HFX Care Team Member can contact you to answer your questions and help you find an HFX-trained doctor. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. “Now I have an active lifestyle for the first time since I was in my 30s. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802). Contact Phone Extension: 6502510005: Phone Extension for the Customer contact. 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. (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or. 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. On (b)(6) 2018 stimulator was not working properly, dr. Nevro hereby declares that the SENZA®, SENZA II®, SENZA Omnia™ is in compliance with the essential. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Dismiss the beeping by pressing and holding the ON/OFF Button for up to 5 seconds. ,ACCK9050,Electrosurgical cable. COM: Phone number for the Customer contact; to be used by patients and consumers for device-related questions. products should be forwarded to: Nevro Corp. 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). 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. Minimal restrictions and reversible. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pocket Erosion (2013). 2. 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 Insufficient Information (4580) Event Date 01/15/2022: Event Type Death Event Description It was reported that the patient passed away. Quick, outpatient & minimally invasive. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). The report indicated that the patient has a history of (b)(6) and was diagnosed with acute kidney. 0005 Fax: +1. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Death (1802); Pneumonia (2011). 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. 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 07/15/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. Photos are for illustration purposes only and may not depict the exact item. 956. . Nevro >. Nevro Announces Participation in Upcoming Investor Conferences. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. NEVRO CORP. NEVRO CORPORATION: Date Received: 2019-05-24:. Lead is a thin. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro’s system is the only device on the market that should be billed with C1822. Model Number NIPG1500: Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191). The device was removed and there have been no reports of. Physician Implant. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. NEVRO CORP. 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 Insufficient Information (4580) Event Date 03/28/2022: Event Type Death Event Description It was reported that the patient passed away. NEVRO CORP. S. (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. 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 07/01/2020: 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. Sign in to add this product to your favorites! Price: $3,530. NEVRO CORP. Senza HFX iQ is the first. Typically safer than other spine surgeries used to address chronic pain 1-5. , lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included. NEVRO CORP. Due Mar 23, 2018. Nevro attempted to obtain additional information regarding the nature of the incident but was unsuccessful. 47909). 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. 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. The patient was hospitalized and was given iv antibiotics. It was reported to nevro that the patient experienced a stroke and a seizure. 251. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. then use the patient ID card to identify Nevro Corp as the manufacturer of the patient’s spinal cord stimulator system. Quick, outpatient & minimally invasive. Nevro attempted to obtain a medical assessment from a healthcare professional but no additional information was available. Please note that MR Conditional components of the. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Nevro Corporation Senza Implantable Pulse Generator Users Manual. 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 05/20/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to.