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. Nevro has complied with regulatory investigation requirements and is submitting. 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 05/09/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. NEVRO CORPORATION: Date Received: 2019-05-24:. 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. NEVRO CORP. Read. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. Do not bring these. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. All questions…Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). 888. 356. 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. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG. USA . 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. delivering stimulation. IMPORTANT: Do not change or modify any component of the Nevro® Senza system, unless expressly approved by 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 Problems Irritation (1941); Complaint, Ill-Defined (2331) Event Date 05/08/2020: Event Type Injury Manufacturer Narrative. (b)(6) determined a defective bracket that held the lead caused the spinal cord stimulator to malfunction, causing the stimulator to stop working. The safety of HFX has been thoroughly studied and proven. Primary DI Number:. Neurostimulation System: Senza Spinal Cord Stimulation System. NEVRO CORP. There were no reports of device-related issues from the patient prior to the passing. 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. One comprehensive solution for individualized relief of chronic pain that gives you more versatility than ever before. 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. Nevro hereby declares that the SENZA®, SENZA II®, SENZA Omnia™ is in compliance with the essential. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. 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. Federal Contract Opportunity for Nevro Corps IPG Kit N0025918N0050. 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. Manufacturer of the medical device. 2 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 10/16/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 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 04/22/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. These letters are chosen by the applicant. NEVRO CORP. D. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Please note that product literature varies by geography. V-6 or V-8 power. 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. 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 12/14/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. Published May 8. 5’ x 15. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. 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. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. 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. 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. NEVRO CORP. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. There were no reports of device-related issues from the patient prior to the passing. 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. 0 million, an increase of 67% compared to $51. 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. Nevro attempted to obtain additional information regarding the nature of the device removal 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 Death (1802) Event Date 05/17/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 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). 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 Hematoma (1884) Event Date 07/01/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 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). All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Search Alerts/Recalls. The battery lights will continue to flash. Nevro attempted to obtain a medical assessment regarding the nature of the issue, but none was available. All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). Contact your Nevro HFX Care Team. Prima di eseguire o raccomandare un esame MRI su un paziente con il sistema Nevro Senza SCS, è importante leggere interamente questo documento. The Senza syste m components will include: Implantable pulse generator (IPG) is a small, battery-powered electronic device that is implanted. Tatevossian and Defendant Greg Khougarnian, M. Die Bluetooth®-Wortmarke und -Logos sind eingetragene Marken von Bluetooth SIG, Inc. It was reported to nevro that the patient was admitted to hospital for breathing difficulties and passed away shortly after. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Trade name: IPG OMNIA NEVRO WITHOUT: Product Code: NIPG2500: Manufacturer of the medical device: NEVRO CORP. ACCK8012-90 Central nervous system electrical stimulation system lead stylet Primary: 00813426020800 4f637b5f-6a9b-47ab-9590-27e6d809f553 Nevro® NEVRO CORP. 251. 47909). 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 Insufficient Information (4580) Event Date 01/15/2022: Event Type Death Event Description It was reported that the patient passed away. The short answer is yes, it’s possible but- it depends on which spinal cord stimulator device you choose. Nevro SCS3 Perc. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. NEVRO CORP. NIPG3000 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Primary: 00813426020718 fc61bdbc-e0e9-4783-8f18-90562bd3d230 Senza. The physician stated that there was no infection and no antibiotics were given to the patient. It was reported to nevro that the patient experienced a stroke and a seizure. B Seite 5. A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e. 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 08/06/2020: Event Type Injury Manufacturer Narrative The device was returned and analysis is currently in progress. 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. Nevro has complied with regulatory investigation requirements and is submitting all. NIPG1000 o NIPG1500). , et al. (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. 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. 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 09/10/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed, and no non-conformities were. Trade name. 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 08/06/2020: Event Type Injury Manufacturer Narrative The device was returned and analysis is currently in progress. 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. products should be forwarded to: Nevro Corp. Good News! Based on your survey responses, Nevro HFX TM could relieve your chronic pain. Nevro attempted to obtain additional information regarding the nature of the numbness but was unsuccessful. NEVRO CORP. Component Model Number(s) Nevro IPG(s) NIPG1000,. inside the body (see IPG in the diagram above). connect to the implan ted IPG. There were no reports of device-related issues from the patient prior to the incident. 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. modello: SADP2008-xxB) e M8 (cod. 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. All questions or concerns about Nevro Corp. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Muscle Spasm(s) (1966). NEVRO CORP. The risk of using other types of RF coils has not been evaluated. It was reported to nevro that the patient passed away due to complications from parkinson¿s disease. Quick, outpatient & minimally invasive. , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. Other trademarks and trade names are those of their respective owners. (b)(6) determined a defective bracket that held. (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or. Primary ID,Brand Name,Company Name,Version or Model,GMDN Terms,Device ID a35b370b-b73b-44e1-a121-dbdfa7a48be9,Nevro® ,NEVRO CORP. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been. and a rechargeable, implantable pulse generator (I PG). NEVRO CORP. The device was ultimately removed due to patient non-compliance and the physician was. 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. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. 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. Surgery on (b)(6) 2018 for the removal of lead, battery, and bracket and replacement of lead. NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE. The Nevro Leads are intended to be used with an IPG or Trial Stimulator for use in . com Description Implantable Pulse Generator Article Number NIPG3000 Pieces per pack 1 Packaging Size 8. 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 06/03/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Primary ID Brand Name Company Name Version or Model GMDN Terms Device ID f417ce9f-5817-4688-b496-446369dcbd82 Senza NEVRO CORP. However, we may not have been able to confirm this information. Nevro >. Primary DI Number: 00813426020015 Issuing Agency: GS1 Commercial Distribution End Date: Device Count:. 1. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Stroke/CVA (1770); Seizures (2063). NEVRO CORP. S. 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. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site. Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR Conditional device that has been demonstrated to present negligible hazards in a specified MR environment when following specific guidelines as described in this document. 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. Use only product literature from the region where the patient procedure was performed. 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 07/07/2020: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. Nevro attempted to obtain additional information regarding the nature of the hospitalization but was unsuccessful. non. Please note that the following components of the Senza system are . The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have 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 Movement Disorder (4412) Event Date 03/04/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. D. Contact your Nevro HFX Care Team. a different manufacturer attached to the Nevro 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 Insufficient Information (4580) Event Date 10/01/2021: Event Type Death Manufacturer Narrative The date of death is an estimate based on information reported. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Swelling (2091); Reaction (2414). NEVRO CORP. 11096 Rev G 5. 5’ Patient Contact Material Titanium, Silicone rubber, Epoxy Product Specifications Product Specification SheetNEVRO CORP. Important safety, side effects, and risks information. Redwood City, CA 94065 USA . NEVRO CORP. Instead of worrying about how to relieve my pain. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD1058-xx(B): LEAD1058-50(B), LEAD1058-70(B), LEAD1058-90(B) Surpass™. The IPG is. Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). One comprehensive solution for individualized relief of chronic pain that gives you more versatility than ever before. 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. Device Name: Senza® IPG Kit. q4cdn. Nevro Corp. 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. On (b)(6) 2018 stimulator was not working properly, dr. Nevro has complied with regulatory investigation requirements and is submitting. The. modello: MADP2008- xxB). NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Arrhythmia (1721). Product Manuals for Healthcare Professionals. The physician noted that the patient has a pre-existing autoimmune disease making her more susceptible to. It was reported to nevro that a patient experienced swelling over the ipg site following the implant procedure. a different manufacturer attached to the Nevro IPG. 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). 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:. Expanding Patient Access to Nevro's HF10® Therapy Through Broader Imaging Compatibility Nevro Corp. SENZA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number NIPG1500: Device Problem Insufficient Information (3190) Patient Problems Purulent Discharge (1812); Erythema (1840); Necrosis (1971); Pain (1994); Swelling (2091)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). 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);. 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. . 356. 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). 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 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. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. The patient was hospitalized and was given iv antibiotics. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system (this information is included on the Abbott Patient ID card). 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. 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 Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Scar Tissue (2060); Spinal Cord Injury (2432) Event Date 07/08/2020: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 01/30/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). It was reported to nevro that the patient was hospitalized. Minimal restrictions and reversible. The risk of using other types of RF coils has not been evaluated. S. 5T Highly Preferred. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have 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 01/06/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. Nevro has complied with regulatory investigation requirements and is submitting all information. Primary Device ID: 00813426020015: NIH Device Record Key: cab471b0-af59-4957-8f6c-36c62219f5c0: Commercial Distribution Status: In Commercial DistributionNEVRO CORP. The manufacturing records were reviewed and no relevant nonconformities were found. 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. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. Federal Contract Opportunity for Neurostimulator Products N0025918N0060. 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. The manufacturing records were reviewed and no issues were found related to the nature of the complaint. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Nausea (1970); Seizures (2063). Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this. The risk of using other types of RF coils has not been evaluated. NIPG1000 Analgesic spinal cord electrical stimulation system (36007) Primary: 00813426020008 36007 Obsolete False 10b480bc-7cc2-4ec1-b41a. 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. Primary ID Brand Name Company Name Version or Model GMDN Terms Device ID a0379068-a2f1-41ec-887e-bf4cb73dbeaa Nevro® NEVRO CORP. The medical device 1500 IPG NEUROSIS WITHOUT is realized by 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 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 CORP. When his doctor recommended an HFX trial, he figured it was worth a shot. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. The. • 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,. The patient continues to use their device with effective pain relief. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 05/02/2016: Event Type Injury Manufacturer Narrative. Anesthesiology, 123(4) 2 Kapural L. There were no reports of device-related issues from the patient prior to the passing. It was reported to nevro that the patient acquired an infection at the pocket site. 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. An electrode: this sits in the epidural space and delivers very small and precise currents. The device had previously been approved for scanning up to 1. Please note that the following components of the Senza system are . Nevro attempted to obtain additional information regarding the nature of the issue but none was available. (Model Nos: 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 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. Important safety, side effects, and risks information. The device was removed and the patient was discharged and is currently recovering. The medical device IPG OMNIA NEVRO WITHOUT is realized by NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Paralysis (1997); Numbness (2415). It was reported to nevro that the patient had the device removed. Posted by. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. (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. 1 Kapural L. 251. 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. wiki >. 2 W/kg head SAR, and up to 80% of the PNS limit). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). There were no reports of device-related issues from the patient prior to the. Nevro has complied with regulatory. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pocket Erosion (2013). Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR. There were no reports of device-related issues from the patient prior to the passing. 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. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 . Nevro attempted to obtain a medical assessment from a healthcare professional but no additional information was available. Setup instructions, pairing guide, and how to reset. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. The patient received physical therapy and regained their leg function. YOU ARE ABOUT TO EXIT FOR A WEBSITE INTENDED FOR THE RESIDENTS OF ANOTHER COUNTRY OR REGION. Safety Info ID#. 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. 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. Company Name: NEVRO CORP. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Myocardial Infarction (1969); Cancer (3262). NEVRO CORP. View 2015 model details Shop Now. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us. NEVRO CORP. Nevro had attempted to obtain additional information regarding the nature of the issue but was unsuccessful. 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 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 01/27/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. 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. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. NEVRO CORP. It was reported to nevro that the patient fell several times and felt their legs had weakened. 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 05/20/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 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. Posted Apr 19, 2018. 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. 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. 0005 1. NEVRO CORP. Please note that the following components of the Senza system are . . Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Death (1802); Pneumonia (2011). Nevro attempted to obtain a medical assessment from the physician but no additional information was available. Visit: IMRSER. It was reported to nevro that the patient experienced spasms following the implant procedure. Nevro, SENZA, SENZA II, Omnia, SENZA Omnia, Senza Bluetooth®, Surpass, Surpass-C, HF10 und das Nevro-Logo sind Marken der 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. 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 12/01/2021: Event Type Injury Event Description It was reported that the patient experienced seizures. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. UserManual. NEVRO CORP. It was reported to nevro that the patient¿s arm was making uncontrolled movements and the patient was hospitalized. I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. SENZA 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. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. ‐ Low SAR mode; SAR set based on device instructions. 10001162 Rev B 6 2. 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. It was reported to nevro that the patient developed an infection at the ipg site. It was reported to nevro that the patient passed away. 1500 IPG NEUROSIS WITHOUT. The report also indicated that the patient is immuno-suppressive due to a kidney transplant. 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. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. NIPG1500: Device Catalogue Number. 1. Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. It was reported to nevro that the patient passed away due to complications from pneumonia. 2. The Chronic Pain Solution The sum of excellence in four key. “Now I have an active lifestyle for the first time since I was in my 30s. 251. 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. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. “Now I have an active lifestyle for the first time since I was in my 30s. It was reported to nevro that the patient was in a rehabilitation facility. 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. It was reported to nevro that a patient was admitted to the er due to report of swelling in the foot and loss of coordination. NEVRO CORP. Nevro attempted to obtain additional information regarding the nature of the device removal but was [email protected] CORP. Patient Manual 11052 Rev A (2015-01-15) [DRAFT] 6 Trial Stimulator is a temporary device that you use outside the body to test to see if the therapy is helpful to you. Typically safer than other spine surgeries used to address chronic pain 1-5. 11096 Rev F. 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). 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. 650. 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. 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. It was reported to nevro that the patient developed an infection at the battery site. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. During a routine call from a nevro representative, it was reported that a patient had acquired an infection post implant. 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. Instead of worrying about how to relieve my pain. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802). Tel: +1. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). It was noted that the patient had a pre-existing condition that limited their mobility. Resources for radiology and pain management clinicians whose patient has a Medtronic spinal cord stimulation system and requires an MRI scan. 3876 Nevro. 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. 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). Tel: +1.