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. HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hypersensitivity/Allergic reaction (1907). 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. On September 17, 2017, based on the representations of Dr. There were no reports of device-related issues from the patient prior to the passing. 888. 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 Neurological Deficit/Dysfunction (1982); Reaction (2414) Event Date 05/14/2019: Event Type Injury Manufacturer Narrative. The patient received physical therapy and regained their leg function. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been. 1. (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. 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 Unspecified Infection (1930) Event Date 01/19/2021: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed and no issues were. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. All questions or concerns about Nevro Corp. Due Apr 24, 2018. It was reported to nevro that a patient had acquired an infection at the ipg pocket post implant. The. wiki >. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Fall (1848); Muscle Weakness (1967). D. (b)(6) determined a defective bracket that held. NEVRO CORP. The device was removed and the patient was discharged and is currently recovering. Dismiss the beeping by pressing and holding the ON/OFF Button for up to 5 seconds. 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 attempted to obtain additional information regarding the nature of the infection, but none was available. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). Nevro attempted to obtain a medical assessment from the physician but no additional information was available. 251. Please note that the following components of the Senza system are . Other trademarks and trade names are those of their respective owners. NEVRO CORP. and is capable of stimulating the spinal cord nerv es when used with one or more leads. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Cardiac Arrest (1762) Event Date 08/05/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Stroke/CVA (1770) Event Date 06/25/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. CE Mark effective on 4 May 2010 . 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel: +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. Nevro attempted to obtain additional information regarding the nature of the incident 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. (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or NIPG1500). • Use only a transmit/receive RF head coil or transmit/receive RF local coil. ď ˇ Lead, instead of connecting to an external stimulator as occurred during the trial phase, will connect to the implanted IPG. When his doctor recommended an HFX trial, he figured it was worth a shot. Trade name. Visit: IMRSER. 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);. Due Mar 23, 2018. It was reported to nevro that the patient¿s arm was making uncontrolled movements and the patient was hospitalized. Nevro Announces Participation in Upcoming Investor Conferences. 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). Do not bring these. 650. 5. Nevro is awaiting the return of the device. 10001162 Rev B 6 2. Manuals are subject to change; the most current version is available on this. 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 Insufficient Information (4580). Version (Model) Number: NIPG1500. 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:. Typically safer than other spine surgeries used to address chronic pain 1-5. 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. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Swelling (2091); Reaction (2414). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 12/18/2021: Event Type Injury Event Description It was reported that the patient was admitted to the icu. 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. 0 Tesla MRI scanners. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Bradycardia (1751); Unspecified Kidney or Urinary Problem (4503) Event Date 03/28/2023: Event Type Injury Manufacturer Narrative. 00 per kit. 2015. However, we may not have been able to confirm this information. It is now the first spinal cord stimulator able to go into the strongest clinical. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. 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 Unspecified Infection (1930) Event Date 07/07/2020: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. g. 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. NEVRO CORP. 5T Highly Preferred. 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. Primary DI Number: 00813426020015 Issuing Agency: GS1 Commercial Distribution End Date: Device Count:. The report also indicated that the patient is immuno-suppressive due to a kidney transplant. 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 05/04/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. NEVRO CORP. The device was removed and there have been no reports of. 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. Lead is a thin. registered trademarks owned by Bluetooth SIG, Inc. Certain Abbott neurostimulation systems are MR Conditional with 1. The IPG is implanted in a subcutaneous pocket. modello: SADP2008-xxB) e M8 (cod. 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 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 has complied with regulatory investigation requirements and is submitting all information. 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). You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pneumonia (2011). 356. Please note that MR Conditional components of the Senza system do not include The trial stimulator (TSM), patient remote, charger, surgical accessories, programmer wand, and clinician programmer. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. Photos are for illustration purposes only and may not depict the exact item. 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 Death (1802) Event Date 06/03/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 1500 IPG NEUROSIS WITHOUT. NEVRO CORP. 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). Many of the Nevro HFX spinal cord stimulator reviews mention the lasting relief it has provided after decades of chronic pain. (Model Nos: NIPG1000 or NIPG1500). It is implanted under the skin and has an inbuilt battery. Category Name. Important safety, side effects, and risks information. Important safety, side effects, and risks information. At a minimum, address the conditions of the static magnetic field, the switched gradient magnetic field and NEVRO CORP. Good News! Based on your survey responses, Nevro HFX TM could relieve your chronic pain. 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. Category Name. . 650. Product Code. NEVRO CORP. 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. 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. 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. The Leads are for single use and interface with the IPG, Lead Extensio ns, OR Cable, and lead accessories. Redwood City, CA 94065 USA . It was reported to nevro that the patient developed an infection at the ipg site. Posted by the Bureau of Medicine and Surgery (DOD - Navy). See. COM: Phone number for the Customer contact; to be used by patients and consumers for device-related questions. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Seroma (2069). 1 Definitions of Terms • MR Conditional1: An item with demonstrated safety in the MR environment within defined conditions. 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). 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 12/29/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. NEVRO CORP. ‐ 1. 0 million in the prior. ď ˇ Lead, instead of connecting to an external stimulator as occurred during the trial phase, will connect to the implanted 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. Prima di eseguire o raccomandare un esame MRI su un paziente con il sistema Nevro Senza SCS, è importante leggere interamente questo documento. 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. 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. An electrode: this sits in the epidural space and delivers very small and precise currents. The. 11096 Rev F. The physician noted that the patient has a pre-existing autoimmune disease making her more susceptible to. HFX has a similar safety profile, including side effects and risks, to other. IPG1500 User Manual PDF Version. During a routine call from a nevro representative, it was reported that a patient's device had been explanted due to infection. 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. 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. Tatevossian and Defendant Greg Khouganian, M. 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). It was reported to nevro that the patient passed away due to complications following a leg amputation related to. Quick, outpatient & minimally invasive. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. Nevro has complied with regulatory. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Muscular Tics (2161). The leads were left in-situ for future reimplant. Contact Phone Extension: 6502510005: Phone Extension for the Customer contact. A spinal cord stimulator system is made of four parts: Impulse Generator (IPG): this is a computer that is roughly the size of a matchbox that controls the impulses delivered to the spinal cord. Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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 submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. The risk of using other types of RF coils has not been evaluated. 5 cycle for 0. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. com MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian Sponsor Emergo Asia Pacific Pty Ltd Expanding Patient Access to Nevro's HF10® Therapy Through Broader Imaging Compatibility Nevro Corp. On September 17, 2017, based on the representations of Dr. 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 12/01/2019: Event Type Injury Event Description It was reported that the patient's device was removed. Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Complaint, Ill-Defined (2331); Insufficient Information (4580). Nevro >. The manufacturing records were reviewed and no relevant nonconformities were found. All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Kidney or Urinary Problem (4503) Event Date 03/29/2023: Event Type Death Event Description It was reported that the patient passed away due to. Nevro Corporation. 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. NIPG1000 o NIPG1500). Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. 15, 2017 /PRNewswire/ - Nevro Corp. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). 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. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 08/01/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. 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). products should be forwarded to: Nevro Corp. inside the body (see IPG in the diagram above). NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System, Neuromodulation System. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Irritation (1941); Complaint, Ill-Defined (2331) Event Date 05/08/2020: Event Type Injury Manufacturer Narrative. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Arrhythmia (1721). 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. These letters are chosen by the applicant. UserManual. Use only product literature from the region where the patient procedure was performed. 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. 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. 5T closed bore scanners subject to conditions in the MRI Procedures Manual. (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. It was reported to nevro that the patient developed an infection at the battery 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. 47909). Nevro attempted to obtain a medical assessment from a healthcare professional but no additional information 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 Cancer (3262) Event Date 02/19/2022: 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 Problem Skin Erosion (2075) Event Date 07/01/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. NEVRO CORP. It was reported to nevro that the patient passed away. S. (b)(6) determined a defective bracket that held the lead caused the spinal cord stimulator to malfunction, causing the stimulator to stop working. 956. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Myocardial Infarction (1969); Cancer (3262). NEVRO CORP. revenue is expected to be approximately $85. Product Sizes: Size Type: N/S (NOT SPECIFIED) Dimension type for the clinically relevant measurement of the medical device. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. non. 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. , lumbar, truncal, in a limb). 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. IMPORTANT: Do not change or modify any component of the Nevro® Senza system, unless expressly approved by Nevro Corp. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Arrhythmia (1721). Please note that the following components of the Senza system are . Nevro attempted to obtain additional information regarding the nature of the hospitalization but was unsuccessful. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Aspiration/Inhalation (1725); Vomiting (2144) Event Date 08/09/2016:. 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 12/25/2020: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 03/15/2020: 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 all information. NIPG1500: Device Catalogue Number. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. Nevro attempted to obtain additional information regarding the nature of the incident but was unsuccessful. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). a different manufacturer attached to the Nevro IPG. NIPG3000 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Primary: 00813426020718 fc61bdbc-e0e9-4783-8f18-90562bd3d230 Senza. 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. 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. (NIPG1500, NIPG2000), Lead Extension kits (MADP2008-25B M8, SADP2008-25B S8), and Lead Adapter kits (LEAD2008-25B, LEAD2008-35B, LEAD2008-60B) of your. 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. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. Physician Implant. 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 passed away two weeks after the implant procedure. 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. 5T Highly Preferred. 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 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. Posted Apr 19, 2018. The patient is currently still using therapy and there have been no reports of further. g. 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 and the specialist have been notably quieter since it was clear the implant was not a 'very' successful one, but they are still supportive. 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. Nevro attempted to obtain a medical assessment from a. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel:. These letters are chosen by the applicant. The battery lights will continue to flash. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Hypertension (4460). The physician believes this was due to being a smoker and non-compliance with. NEVRO CORP. S. Sign in to add this product to your favorites! Price: $3,530. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). 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. Nevro submits this report in compliance with fda's medical device reporting regulations under 21 cfr part 803. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 03/28/2022: Event Type Death Event Description It was reported that the patient passed away. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. When his doctor recommended an HFX trial, he figured it was worth a shot. Every person is unique and your. Product Manuals for Patients. Nevro attempted to obtain additional information regarding the nature of the device removal but was [email protected] CORP. Redwood City, CA 94065 USA . a different manufacturer attached to the Nevro IPG. Primary DI Number:. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. 2. 47909). Product Code. 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1. Company Name: NEVRO CORP. Federal Contract Opportunity for Neurostimulator Products N0025918N0060. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 08/06/2021: 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 Problems Paralysis (1997); Numbness (2415). 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. 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. NEVRO CORP. For this reason, always talk to your doctor if youThe Senza System has a very similar safety profile to other SCS devices that have been available for many years. HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment of chronic pain. ,ACCK9050,Electrosurgical cable. Photos are for illustration purposes only and may not depict the exact item. Surgery on (b)(6) 2018 for the removal of lead, battery, and bracket and replacement of lead. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. The device was ultimately removed due to patient non-compliance and the physician was. 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. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pneumonia (2011). Product Code Description Revenue Code HCPCS Code NIPG1000 or NIPG1500 or NIPG2500 IPG Kit 278 C1822 CHGR1000 or CHGR2500 Charger Kit 278 C1822 Most commercial plans provide guidance in their medical policies about which device HCPCS codes to report on claims. , et al. NEVRO CORP. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. On (b)(6) 2018 stimulator was not working properly, dr. (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. It was reported to nevro that the patient experienced numbness in the arm. NEVRO CORP. delivering stimulation. Component Model Number(s) Nevro IPG(s) NIPG1000,. 1. 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. Use only product literature from the region where the patient procedure was performed. The manufacturing records were reviewed and no relevant nonconformities were found. It was reported to nevro that the patient¿s incision site was not healing well and opening up. NEVRO CORP. The Nevro Leads are intended to be used with an IPG or Trial Stimulator for use in . NEVRO CORP. 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. 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 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. modello: MADP2008- xxB). Nevro attempted to obtain more information regarding the nature of the issue, but none was available. NEVRO CORP. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. 187. All questions or concerns about Nevro Corp. NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE. It was reported to nevro that the patient passed away. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System (LivaNova and Cyberonics, Inc. 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). ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). 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. Posted Mar 21, 2018. Trade name. NEVRO CORP. found. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 07/21/2020: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. 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. The device had previously been approved for scanning up to 1. It was reported to nevro that the patient acquired an infection at the pocket site. NEVRO CORP. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. It was reported to nevro that the patient was hospitalized. The short answer is yes, it’s possible but- it depends on which spinal cord stimulator device you choose. ). 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 06/26/2019: 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. NIPG1500. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Catalog Number: NIPG1500 Company Name: NEVRO CORP. The report indicated that the patient has a history of (b)(6) and was diagnosed with acute kidney. NEVRO CORP. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. Nevro has complied with regulatory investigation requirements and is submitting all. 650. includono gli adattatori per elettrocateteri S8 (cod. Nevro has complied with regulatory investigation requirements and is submitting. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). B Seite 5. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. . 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,. NEVRO CORP. 47909). 47909). Nevro has complied with regulatory investigation requirements and is submitting. Please note that the following components of the Senza system are . a different manufacturer attached to the Nevro IPG. I am. 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. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. View 2015 model details Shop Now. Some spinal cord stimulators are safe for an MRI, but others aren’t. 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. 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. 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). 5T or 3T transmit / receive RF head coil, as long as the implanted Nevro Senza system components are not within the transmit / receive. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 05/28/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to.