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. a different manufacturer attached to the Nevro IPG. s28. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 08/06/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. The manufacturing records were reviewed and no relevant nonconformities were found. 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 attempted to obtain a medical assessment from a healthcare professional but no additional information was available. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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 Implant Pain (4561) Event Date 01/25/2022: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. 251. 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. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. products, including any serious incident that has occurred in relation to the device, should be forwarded to: Nevro Corp. NEVRO CORP. All questions…The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). a different manufacturer attached to the Nevro IPG. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 05/09/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 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 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. Posted Apr 19, 2018. The battery lights will continue to flash. 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. Sign in to add this product to your favorites! Price: $3,530. Intended Purpose The IPG Kit consists of an implantable pulse generator which is a component of the Nevro Spinal Cord Stimulation System that is intended to aid in the management of chronic intractable pain of the trunk and/or limbs. 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. , et al. 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 and the specialist have been notably quieter since it was clear the implant was not a 'very' successful one, but they are still supportive. It was reported to nevro that the patient's device was removed due to an emergency upper back surgery. 11096 Rev G 5. 0005 Fax: +1. Component Model Number(s) Nevro IPG(s) NIPG1000,. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Myocardial Infarction (1969); Cancer (3262). 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. Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. 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 Death (1802) Event Date 10/03/2019: 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 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. 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. NEVRO CORP. and is capable of stimulating the spinal cord nerv es when used with one or more leads. NEVRO CORP. Lead is a thin. 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. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. 956. 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. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). NEVRO CORP. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. 0005 . Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8. Many of the Nevro HFX spinal cord stimulator reviews mention the lasting relief it has provided after decades of chronic pain. Quick, outpatient & minimally invasive. , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. 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). The physician believes the cause of death was pneumonia and not device related. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Hypertension (4460). There were no reports of device-related issues from the patient prior to the. It was reported to nevro that the patient was hospitalized for seizures. NEVRO CORP. Other trademarks and trade names are those of their respective owners. NIPG1500: Device Catalogue Number. 0 million in the prior. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. Category Name. 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. Manuals are. Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. Nevro has complied with regulatory investigation requirements and is submitting. Please note that the following components of the Senza system are . NIPG1500. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. 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. MR Unsafe: AccessGUDID - Omnia (00813426020572)- Senza Omnia IPG Kit An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e. The device was removed and the patient was discharged and is currently recovering. 1. NIPG3000 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Primary: 00813426020718 fc61bdbc-e0e9-4783-8f18-90562bd3d230 Senza. 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). When his doctor recommended an HFX trial, he figured it was worth a shot. 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. The patient was hospitalized and the device was explanted. 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). 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. 5’ x 15. Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility REDWOOD CITY, California , Nov. The leads were left in-situ for future reimplant. The work will be performed at 34800 Bob Wilson Dr, San. 251. Get your discussion guide to start a conversation with your doctor. a different manufacturer attached to the Nevro IPG. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. 47909). IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. USA . NEVRO CORP. Federal Contract Opportunity for Neurostimulator Products N0025918N0060. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site. 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 Problem Muscle Spasm(s) (1966). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. Catalog Number: NIPG1500 Company Name: NEVRO CORP. The patient was hospitalized and was given iv antibiotics. Nevro Corp. 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 Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Scar Tissue (2060); Spinal Cord Injury (2432) Event Date 07/08/2020:NEVRO CORP. Some spinal cord stimulators are safe for an MRI, but others aren’t. NEVRO CORP. NIPG1500 Analgesic spinal cord electrical stimulation system (36007) Primary: 00813426020015 36007 Obsolete False cff739ed-d67c-4c70-9456-987f754ece45 Senza® 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. 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. (NIPG1500, NIPG2000), Lead Extension kits (MADP2008-25B M8, SADP2008-25B S8), and Lead Adapter kits (LEAD2008-25B, LEAD2008-35B, LEAD2008-60B) of your. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. NEVRO CORP. 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 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. Product Manuals for Healthcare Professionals. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. 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 07/15/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). NEVRO CORP. 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,. Redwood City, CA 94065 USA . It was reported to nevro that the patient¿s arm was making uncontrolled movements and the patient was hospitalized. 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 acquired an infection and had the device removed. On September 17, 2017, based on the representations of Dr. 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. Version (Model) Number: NIPG1500. Please note that product literature varies by geography. (b)(6) determined a defective bracket that held. 1500 IPG NEUROSIS WITHOUT. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. NEVRO CORP. 5. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. Contact your Nevro HFX Care Team. 3 Million and Plans to Update Guidance When It Reports Second Quarter 2021 Financial Results on August 4, 2021 Nevro Corp. Tel: +1. Safety Info ID#. is under license. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. On September 17, 2017, based on the representations of Dr. 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. We Believe True Innovation Transforms More Lives 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 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 incident but was unsuccessful. Nevro has complied with regulatory investigation requirements and is submitting all. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. Federal Contract Opportunity for Nevro Corps IPG Kit N0025918N0050. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. found. ‐ Low SAR mode; SAR set based on device instructions. Nevro >. HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment of chronic pain. It was reported to nevro that the patient passed away due to complications from pneumonia. The Senza and Senza II Systems are implantable systems and deliver stimulation using implantable leads. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). a different manufacturer attached to the Nevro IPG. On September 17, 2017, based on the representations of Dr. . The report also indicated that the patient is immuno-suppressive due to a kidney transplant. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. and any use of such marks by Nevro Corp. ‐ 1. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. 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. There were no reports of device-related issues from the patient prior to the incident. It was reported to nevro that the patient was hospitalized. The physician stated that there was no infection and no antibiotics were given to the patient. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Complaint, Ill-Defined (2331); Insufficient Information (4580). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 01/27/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. 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. NEVRO CORP. Read. Nevro has complied with regulatory investigation requirements and is submitting all information. 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 Hematoma (1884) Event Date 07/01/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Please note that the following components of the Senza system are . 9415 info@nevro. 187. 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. The risk of using other types of RF coils has not been evaluated. D. It was reported to nevro that the patient was admitted to hospital for breathing difficulties and passed away shortly after. If the user interruptions and for 0. 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. g. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. 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);. Primary ID,Brand Name,Company Name,Version or Model,GMDN Terms,Device ID a35b370b-b73b-44e1-a121-dbdfa7a48be9,Nevro® ,NEVRO CORP. For Trial Patients (TSM3000/TSM3500) How to Use Your Trial Device Your Nevro HFX Care Team Contact Information Please call 1-844-331-1001About Nevro Headquartered in Redwood City, California , Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. 47909). Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Nausea (1970); Seizures (2063). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Convulsion/Seizure (4406) Event Date 01/10/2022: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). 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. NEVRO SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results:. The. View 2015 model details Shop Now. • 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,. 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 Insufficient Information (4580). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 03/28/2022: Event Type Death Event Description It was reported that the patient passed away. 5T Highly Preferred. Avoid activities that put stress on the implanted neurostimulation system components. It was reported to nevro that a patient had acquired an infection following a permanent implant. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 03/15/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. It was reported to nevro that the patient acquired an infection at the pocket site. Company Name: NEVRO CORP. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 07/16/2020: Event Type Death Manufacturer Narrative A review of the complaint database has found no other instances of similar. 5 Tesla. High roof or standard roof. Nevro Corporation. 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. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 01/29/2022: Event Type Death Event Description It was reported that the patient passed away. The. 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. 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 Pain (1994) Event Date 12/14/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. The physician believes this was due to being a smoker and non-compliance with. 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. It was reported to nevro that the patient passed away. NEVRO CORP. NEVRO CORP. 5 cycle for 0. Nevro attempted to obtain additional information regarding the nature of the hospitalization but was unsuccessful. NEVRO SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results:. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). Neurostimulation System: Senza Spinal Cord Stimulation System. 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. 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. It was reported to nevro during a patient's follow up that a patient had acquired an infection 4 months post implant. 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 Problems Skin Erosion (2075); Pressure Sores (2326) Event Date 02/03/2022: Event Type Injury Manufacturer Narrative. At a minimum, address the conditions of the static magnetic field, the switched gradient magnetic field and 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 Unspecified Infection (1930); Impaired Healing (2378) Event Date 05/08/2020: Event Type Injury Manufacturer Narrative. 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). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Muscular Tics (2161). Nevro hereby declares that the SENZA®, SENZA II®, SENZA Omnia™ is in compliance with the essential. The Chronic Pain Solution The sum of excellence in four key. g. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. Surgery on (b)(6) 2018 for the removal of lead, battery, and bracket and replacement of lead. 9415 [email protected] or Model: NIPG1500. Please note that the following components of the Senza system are . The manufacturing records were reviewed and no relevant nonconformities were found. 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. Photos are for illustration purposes only and may not depict the exact item. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. NEVRO CORP. Contact your Nevro HFX Care Team. 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 02/28/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Product Code. NEVRO CORP. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. and a rechargeable, implantable pulse generator (I PG). The medical device 1500 IPG NEUROSIS WITHOUT is realized by NEVRO CORP. q4cdn. An electrode: this sits in the epidural space and delivers very small and precise currents. NEVRO CORP. It was reported to nevro that a patient had acquired an infection at the ipg pocket post implant. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 03/31/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. 0005 The Senza System has a very similar safety profile to other SCS devices that have been available for many years. 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. Redwood City, CA 94065 USA . 1800 Bridge Parkway . YOU ARE ABOUT TO EXIT FOR A WEBSITE INTENDED FOR THE RESIDENTS OF ANOTHER COUNTRY OR REGION. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. 1. 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. “Now I have an active lifestyle for the first time since I was in my 30s. 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 09/20/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. Posted by. Company Name: NEVRO CORP. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. IPG1500 User Manual PDF Version. 1800 Bridge Parkway Redwood City, CA 94065 USA 1. Product Manuals for Healthcare Professionals. 356. Nevro attempted to obtain additional information regarding the nature of the incident but was unsuccessful. NIPG1500. . I am. NEVRO CORP. Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). The IPG is. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. 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. Novel 10-kHz High-frequency Therapy Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. It was reported to nevro that the patient passed away due to complications from pneumonia. D. “Now I have an active lifestyle for the first time since I was in my 30s. Nevro has complied with regulatory investigation requirements and is submitting all information. The IPG is implanted in a subcutaneous pocket. It was reported to nevro that the patient passed away. NEVRO CORP. Minimal restrictions and reversible. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. Category Name. 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 02/03/2021: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. The device had previously been approved for scanning up to 1. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. 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. 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. These letters are chosen by the applicant. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. Please note that product literature varies by geography. Use only product literature from the region where the patient procedure was performed. Do not bring these. Nevro attempted to obtain a medical assessment regarding the nature of the issue, but none was available. delivering stimulation. 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 Paralysis (1997); Numbness (2415). HFX Spinal Cord Stimulation is a nondrug, FDA-approved, treatment option for long-term chronic pain relief. 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. On (b)(6) 2018 stimulator was not working properly, dr. NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE. 0 Tesla MRI scanners. Nevro attempted to obtain a medical assessment from a. 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 Stroke/CVA (1770) Event Date 06/25/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 01/01/2019: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. 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. Photos are for illustration purposes only and may not depict the exact item. It was reported to nevro that the patient developed an infection at the ipg site. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 02/08/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. The 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. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802). Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. ‐ 1. 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. NEVRO CORP. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xxB: LEAD1058-50B, LEAD1058-70B, LEAD1058-90B Surpass® Surgical. 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 has complied with regulatory investigation requirements and is submitting all information. Every person is unique and your. The manufacturing records were reviewed and no issues were found related to the nature of the complaint. 2. Nevro Announces Participation in Upcoming Investor Conferences. 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 07/25/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. Good News! Based on your survey responses, Nevro HFX TM could relieve your chronic pain. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 04/10/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to the nature of. S. 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. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System, Neuromodulation System. Lead, instead of connecting to an external stimulator as occurred during the trial phase, will. • 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.