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 Insufficient Information (4580) Event Date 06/01/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 01/11/2022: Event Type Injury Manufacturer Narrative. The work will be performed at 34800 Bob Wilson Dr, San. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xxB: LEAD1058-50B, LEAD1058-70B, LEAD1058-90B Surpass® Surgical. Primary Device ID: 00813426020015: NIH Device Record Key: cab471b0-af59-4957-8f6c-36c62219f5c0: Commercial Distribution Status: In Commercial DistributionNEVRO 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 01/13/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. NEVRO CORP. Nevro has complied with regulatory investigation requirements and is submitting. One comprehensive solution for individualized relief of chronic pain that gives you more versatility than ever before. modello: MADP2008- xxB). High roof or standard roof. Other trademarks and trade names are those of their respective owners. (b)(6) determined a defective bracket that held the lead caused the spinal cord stimulator to malfunction, causing the stimulator to stop working. Die Bluetooth®-Wortmarke und -Logos sind eingetragene Marken von Bluetooth SIG, Inc. Safety Topic / Subject. 2 NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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 attempted to obtain additional information regarding the nature of the infection, but none was available. 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 Movement Disorder (4412) Event Date 03/04/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. Quick, outpatient & minimally invasive. NEVRO CORP. It was reported to nevro that a patient had acquired an infection following a permanent implant. HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment of chronic pain. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. NEVRO CORP. modello: SADP2008-xxB) e M8 (cod. During a routine call from a nevro representative, it was reported that a patient's device had been explanted due to infection. 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 Unspecified Infection (1930). com MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian Sponsor Emergo Asia Pacific Pty Ltd Nevro SENZA®, SENZA II® and SENZA Omnia™ Spinal Cord Stimulation (SCS). 2 NEVRO CORP. 5/ 3-tesla closed, horizontal bore 15 min active scan time; must have all components out of head coil; stimulation off LEAD2008-xxB (extension), ACCK5xxx (lead anchor) and ACCK7000 (IPG port plug) MRSENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331) Event Date 08/06/2020: Event Type Injury Manufacturer Narrative The device was returned and analysis is currently in progress. All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Fall (1848); Muscle Weakness (1967). Product Code. 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. It was reported to nevro that the patient was hospitalized. 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. NIPG1500: Device Catalogue Number. 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 08/06/2020: Event Type Injury Manufacturer Narrative The device was returned and analysis is currently in progress. NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE. The patient received physical therapy and regained their leg function. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Skin Erosion (2075) Event Date 07/01/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. Nevro-IPG NIPG1000, NIPG1500, NIPG2000, NIPG2500SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Electric Shock (2554) Event Date 07/03/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to the nature of. (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. Version (Model) Number: NIPG1500. S. 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. Category Name. Lead, instead of connecting to an external stimulator as occurred during the trial phase, will. Nevro attempted to obtain a medical assessment from a healthcare professional but no additional information was available. CE Mark effective on 4 May 2010 . 650. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. Follow up report indicated that the infection has cleared and the patient had recovered without sequelae. g. Trade name: IPG OMNIA NEVRO WITHOUT: Product Code: NIPG2500: Manufacturer of the medical device: 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 06/26/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. 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. NEVRO CORP. NEVRO CORP. Contact Phone Extension: 6502510005: Phone Extension for the Customer contact. Nevro attempted to obtain additional information regarding the nature of the device removal but was [email protected] CORP. The report also indicated that the patient is immuno-suppressive due to a kidney transplant. wiki >. (NYSE: NVRO), a. B Seite 5. Prima di eseguire o raccomandare un esame MRI su un paziente con il sistema Nevro Senza SCS, è importante leggere interamente questo documento. Instead of worrying about how to relieve my pain. 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. It was reported to nevro that the patient experienced numbness in the arm. It was reported to nevro that the patient's device was removed due to an emergency upper back surgery. The device had previously been approved for scanning up to 1. Minimal restrictions and reversible. Nevro has complied with regulatory investigation requirements and is submitting all information. NIPG3000 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Primary: 00813426020718 fc61bdbc-e0e9-4783-8f18-90562bd3d230 Senza. NEVRO CORP. Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. Nevro attempted to obtain additional information regarding the nature of the device removal but none was available. ď ˇ Lead, instead of connecting to an external stimulator as occurred during the trial phase, will connect to the implanted IPG. The medical device IPG OMNIA NEVRO WITHOUT is realized by NEVRO CORP. The safety of HFX has been thoroughly studied and proven. Important safety, side effects, and risks information. 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. The device was removed and the patient was discharged and is currently recovering. Safety Info ID#. Device Name: Senza® IPG Kit. Every person is unique and your. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. NEVRO CORP. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. NEVRO CORP. 0005 Fax: +1. I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. 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 Nausea (1970); Seizures (2063). NEVRO CORP. NEVRO CORP. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 01/30/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. Nevro Corp has received European and Australian approval for its Senza spinal cord stimulator, designed to reduce pain, to be compatible, under specific conditions, with 3. All questions or concerns about Nevro Corp. During a routine call from a nevro representative, it was reported that a patient had acquired an infection post implant. We would like to show you a description here but the site won’t allow us. 2015. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pain (1994) Event Date 09/23/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. It was reported to nevro that the patient was admitted to hospital for breathing difficulties and passed away shortly after. 5. , lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included. It was noted that the patient had been using the device with effective pain relief. 5’ Patient Contact Material Titanium, Silicone rubber, Epoxy Product Specifications Product Specification SheetNEVRO CORP. , et al. 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. NEVRO CORP. 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 Insufficient Information (4580) Event Date 12/01/2019: Event Type Injury Event Description It was reported that the patient's device was removed. 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. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. 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. 9415 info@nevro. com Description Implantable Pulse Generator Article Number NIPG3000 Pieces per pack 1 Packaging Size 8. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Swelling (2091); Reaction (2414). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). 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 Death (1802) Event Date 05/28/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 1. (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 Insufficient Information (4580) Event Date 01/30/2022: 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 Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Scar Tissue (2060); Spinal Cord Injury (2432) Event Date 07/08/2020:NEVRO CORP. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. Figure 1: Head MRI scans are permissible using 1. The patient was hospitalized and was given iv antibiotics. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Krishnan Chakravarthy serves as a consultant to Abbott, Medtronic, Bioness, SPR Therapeutics, Nalu Medical, Omnia Medical, and Saluda Medical; founder of Newrom Biomedical; and holds equity in Nalu Medical and Oska W • 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 Nevro’s system is the only device on the market that should be billed with C ô î î. 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. Request A Paper Manual. 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 Death (1802) Event Date 01/27/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. NEVRO CORP. 5 cycle for 0. Please note that the following components of the Senza system are . D. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 . Nevro submits this report in compliance with fda's medical device reporting regulations under 21 cfr part 803. It was reported to nevro that the patient was in a rehabilitation facility. Use only product literature from the region where the patient procedure was performed. ,ACCK9050,Electrosurgical cable. The IPG is implanted in a subcutaneous pocket. 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. The manufacturing records were reviewed and no issues were found related to the nature of the complaint. Setup instructions, pairing guide, and how to reset. Trade name. Please note that product literature varies by geography. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). 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. Nevro has complied with regulatory investigation requirements and is submitting all information. , mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for. HFX has a similar safety profile, including side effects and risks, to other. 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 Insufficient Information (4580) Event Date 06/06/2020: Event Type Death Manufacturer Narrative The date of death is estimated based on diagnostic data provided. I componenti MR Conditional del sistema Senza . 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1. HFX Spinal Cord Stimulation is a nondrug, FDA-approved, treatment option for long-term chronic pain relief. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel: +1. Article Text. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. Tel: +1. 251. The Senza and Senza II Systems are implantable systems and deliver stimulation using implantable leads. Manuals are subject to change; the most current version is available on this. , lumbar, truncal, in a limb). The manufacturing records were reviewed and no relevant nonconformities were found. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Anesthesiology, 123(4) 2 Kapural L. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG. NEVRO CORP. NEVRO CORP. NEVRO CORP. Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR. 9415 [email protected] or Model: 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 01/03/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Inflammation (1932) Event Date 10/20/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to the nature of. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-month Results from a Multicenter. Primary DI Number:. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. 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). 2015. Nevro Announces Participation in Upcoming Investor Conferences. It was reported to nevro that the patient acquired an infection and had the device removed. Published May 8. It was reported to nevro that the patient experienced a hemorrhage requiring surgical intervention. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 06/24/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. is under license. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System, Neuromodulation System. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. 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. V-6 or V-8 power. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). Please note that the following components of the Senza system are . Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Neurological Deficit/Dysfunction (1982); Reaction (2414) Event Date 05/14/2019: Event Type Injury Manufacturer Narrative. NEVRO CORP. The. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Reaction (2414) Event Date 06/28/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 02/03/2021: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. Global Unique Device ID: 00813426020015. 1500 IPG NEUROSIS WITHOUT. , et al. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); Sepsis (2067) Event Date 06/12/2019: Event Type Injury Manufacturer Narrative. Nevro attempted to obtain additional information regarding the nature of the issue but none was available. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Foreign Body Reaction (1868) Event Date 02/10/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. 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 available diagnostic data showed no indications of a device. 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. 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. Nevro has complied with regulatory. Important safety, side effects, and risks information. NEVRO CORP. Use only product literature from the region where the patient procedure was performed. Tatevossian and Defendant Greg Khougarnian, M. There were no reports of device-related issues from the patient prior to the. (Model Nos: NIPG1000 or NIPG1500). 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. 1. Product Manuals for Patients. a different manufacturer attached to the Nevro IPG. 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. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); Impaired Healing (2378) Event Date 05/08/2020: Event Type Injury Manufacturer Narrative. 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. q4cdn. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Renal Failure (2041) Event Date 11/08/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed, and no non-conformities were found. NEVRO CORP. NIPG1000 o 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. The device was removed and there have been no reports of. 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 Complaint, Ill-Defined (2331) Event Date 01/27/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 3 Million and Plans to Update Guidance When It Reports Second Quarter 2021 Financial Results on August 4, 2021 Nevro Corp. Tatevossian and Defendant Greg Khouganian, M. The manufacturing records were reviewed and no relevant nonconformities were found. 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 Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility REDWOOD CITY, California , Nov. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Arrhythmia (1721). NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Abnormal Vaginal Discharge (2123). 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 09/01/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature of the. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 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 Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191). NIPG1500 Analgesic spinal cord electrical stimulation system (36007) Primary: 00813426020015 36007 Obsolete False cff739ed-d67c-4c70-9456-987f754ece45 Senza® NEVRO CORP. 356. s28. Posted Mar 21, 2018. On September 17, 2017, based on the representations of Dr. NEVRO CORP. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 01/19/2021: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed and no issues were. On September 17, 2017, based on the representations of Dr. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. 888. products should be forwarded 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 Death (1802) Event Date 12/29/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. 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. There were no reports of device-related issues from the patient prior to the. 251. 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). Certain Abbott neurostimulation systems are MR Conditional with 1. Expanding Patient Access to Nevro's HF10® Therapy Through Broader Imaging Compatibility Nevro Corp. a different manufacturer attached to the Nevro IPG. For Trial Patients (TSM3000/TSM3500) How to Use Your Trial Device Your Nevro HFX Care Team Contact Information Please call 1-844-331-1001 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 patients suffering from debilitating chronic pain. 251. 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. 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. 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 Complaint, Ill-Defined (2331); Insufficient Information (4580). Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8. YOU ARE ABOUT TO EXIT FOR A WEBSITE INTENDED FOR THE RESIDENTS OF ANOTHER COUNTRY OR REGION. 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 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. 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. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Wound Dehiscence (1154); Impaired Healing (2378). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Seroma (2069). NEVRO CORP. Preliminary, unaudited second quarter 2021 U. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. 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 the physician but no additional information was available. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. 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. 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. Photos are for illustration purposes only and may not depict the exact item. Neurostimulation System: Senza Spinal Cord Stimulation System. It was reported to nevro that the patient acquired an infection at the pocket site. S. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. 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 05/08/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site. Every person is unique and your medical needs differ from those of others, even people with the same condition and the same SCS system. There were no reports of device-related issues from the patient prior to the passing. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Death (1802); Pneumonia (2011). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). delivering stimulation. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). Published May 8. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-• You have a Nevro spinal cord stimulator • If you have any other medical device implants • A detailed description of your devices, including the product number of the implant, leads, and other implanted componentsNevro’s system is the only device on the market that should be billed with C ô î î. Company Announces Preliminary, Unaudited Second Quarter 2021 Revenue of Approximately $102. Catalog Number: NIPG1500 Company Name: NEVRO CORP. NIPG1500: Device Catalogue Number. Some spinal cord stimulators are safe for an MRI, but others aren’t. connect to the implan ted 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 07/15/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. 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 Problems Myocardial Infarction (1969); Cancer (3262). The risk of using other types of RF coils has not been evaluated. PRECAUTIONS. View 2015 model details Shop Now. 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. NEVRO CORP. These letters are chosen by the applicant. The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. Contact your Nevro HFX Care Team. Nevro has complied with regulatory. Trade name. The safety of HFX has been thoroughly studied and proven. (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or NIPG1500). a different manufacturer attached to the Nevro IPG. 650. NEVRO SPINAL CORD STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number NIPG1500: Device Problems Defective Device (2588); Material Deformation (2976); Therapeutic or Diagnostic Output Failure (3023) Patient Problem Failure of Implant (1924)NEVRO CORP. 1800 Bridge Parkway Redwood City, CA 94065 USA 1. 00 per kit. Search Alerts/Recalls. 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 hereby declares that the SENZA®, SENZA II®, SENZA Omnia™ is in compliance with the essential. Nevro has complied with regulatory investigation requirements and is submitting all. 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. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331) Event Date 03/12/2020: Event Type Injury Manufacturer Narrative Nevro is awaiting the return of the device. It was reported to nevro that the patient experienced spasms following the implant procedure. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. IPG1500 User Manual PDF Version. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 01/06/2021: 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 Insufficient Information (4580). “Now I have an active lifestyle for the first time since I was in my 30s. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. ď ˇ Lead, instead of connecting to an external stimulator as occurred during the trial phase, will connect to the implanted IPG.