All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). The risk of using other types of RF coils has not been evaluated. Mode of MR operation in which none of the outputs have a value that may cause physiological stress to patients (2 W/kg whole body SAR, 3. 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. Primary DI Number: 00813426020015 Issuing Agency: GS1 Commercial Distribution End Date: Device Count:. 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. Minimal restrictions and reversible. Nevro attempted to obtain a medical assessment from the physician 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 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 Seroma (2069) Event Date 08/03/2016: Event Type Injury Manufacturer Narrative The device was not explanted. 1. Published May 8. The safety of HFX has been thoroughly studied and proven. Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. 5T closed bore scanners subject to conditions in the MRI Procedures Manual. NEVRO CORP. g. S. 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 Skin Erosion (2075) Event Date 07/01/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. Please note that MR Conditional components of the. Version (Model) Number: NIPG1500. Catalog Number: NIPG1500. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pocket Erosion (2013). 251. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Complete the form below so a Nevro HFX Care Team Member can contact you to answer your questions and help you find an HFX-trained doctor. Component Model Number(s) Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000 Nevro Percutaneous Leads LEAD10x8-xx(B) Lead Extensions LEAD2008-xx(B) Lead Anchors All models (ACCK5000, ACCK5101, ACCK5200, ACCK5300) NEVRO CORP. NEVRO CORP. Please note that the following components of the Senza system are . 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 has complied with regulatory. Preliminary, unaudited second quarter 2021 U. 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 attempted to obtain additional information regarding the nature of the surgery but was. For example, the grantee code for FCC ID: XKYIPG1500 is XKY. delivering stimulation. NEVRO CORP. Nevro Announces Participation in Upcoming Investor Conferences. 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. 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. NIPG1500: Device Catalogue Number. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site. 5. Category Name. Novel 10-kHz High-frequency Therapy Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. The medical device IPG OMNIA NEVRO WITHOUT is realized by NEVRO CORP. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Arrhythmia (1721). Nevro Senza Spinal Cord Stimulator ‐ MRI available Mon‐Fri, 8am‐5pm; Univ Hospital Only. 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. 956. There were no reports of device-related issues from the patient prior to the. NEVRO CORP. 11096 Rev F. Nevro attempted to obtain additional information regarding the nature of the incident 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 Problems Wound Dehiscence (1154); Unspecified Infection (1930) Event Date 10/22/2019: Event Type Injury Manufacturer Narrative. It was noted that the patient had a pre-existing condition that limited their mobility. NEVRO CORP. (Model Nos: NIPG1000 or NIPG1500). All questions or concerns about Nevro products should be forwarded to: Nevro Corp. The battery lights will continue to flash. NEVRO CORP. Catalog Number: NIPG1500 Company Name: NEVRO CORP. The patient is currently still using therapy and there have been no reports of further. 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. 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 Insufficient Information (4580) Event Date 03/28/2022: Event Type Death Event Description It was reported that the patient passed away. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. 5 Tesla. 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. ACCK8012-70 Central nervous. NEVRO CORP. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 01/30/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. The patient was hospitalized and the device was explanted. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 08/01/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. NEVRO CORP. For Trial Patients (TSM3000/TSM3500) How to Use Your Trial Device Your Nevro HFX Care Team Contact Information Please call 1-844-331-1001 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. Safety Info ID#. Federal Contract Opportunity for Neurostimulator Products N0025918N0060. All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). 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 10/23/2020: 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 06/03/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Photos are for illustration purposes only and may not depict the exact item. Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). ‐ 1. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Swelling (2091); Reaction (2414). High roof or standard roof. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Cardiac Arrest (1762) Event Date 08/05/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. Nevro has complied with regulatory investigation requirements and is submitting all. Please note that the following components of the Senza system are . Please note that the following components of the Senza system are . 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. 356. 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. , mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for. NEVRO CORP. Manuals are subject to change; the most current version is available on this page. 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. 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. It was reported to nevro that the patient passed away due to complications from parkinson¿s disease. 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. 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 Problems Stroke/CVA (1770); Seizures (2063). (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or NIPG1500). 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 additional information regarding the nature of the device removal but none was available. Product Manuals for Healthcare Professionals. (3T has severe limitations. 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). Manufacturer of the medical device. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pocket Erosion (2013). 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. It was reported to nevro that the patient experienced a hemorrhage requiring surgical intervention. It was reported to nevro that the patient fell several times and felt their legs had weakened. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Impaired Healing (2378) Event Date 01/31/2022: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. Federal Contract Opportunity for Nevro Corps IPG Kit N0025918N0050. NEVRO CORP. 650. Now Available, FDA-Approved, Artificial Intelligence-based HFX iQ™. It was reported to nevro that the patient was hospitalized for seizures. Product Manuals for Patients. registered trademarks owned by Bluetooth SIG, Inc. Typically safer than other spine surgeries used to address chronic pain 1-5. The physician noted that the patient has a pre-existing autoimmune disease making her more susceptible to. Due Apr 24, 2018. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Death (1802); Pneumonia (2011). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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 CORP. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hypersensitivity/Allergic reaction (1907). It was reported to nevro during a patient's follow up that a patient had acquired an infection 4 months post implant. It was reported to nevro that the patient passed away due to complications from pneumonia. The short answer is yes, it’s possible but- it depends on which spinal cord stimulator device you choose. s28. Primary DI Number:. 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. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System (LivaNova and Cyberonics, Inc. The patient continues to use their device with effective pain relief. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xxB: LEAD1058-50B, LEAD1058-70B, LEAD1058-90B Surpass® Surgical. ACCK8012-90 Central nervous system electrical stimulation system lead stylet Primary: 00813426020800 4f637b5f-6a9b-47ab-9590-27e6d809f553 Nevro® NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. It was reported to nevro that the patient experienced spasms following the implant procedure. 0 million in the prior. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Nausea (1970); Seizures (2063). One comprehensive solution for individualized relief of chronic pain that gives you more versatility than ever before. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. 1. Quick, outpatient & minimally invasive. The safety of HFX has been thoroughly studied and proven. 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. Posted Apr 19, 2018. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Wound Dehiscence (1154); Impaired Healing (2378). Nevro has complied with regulatory investigation requirements and is submitting all information. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 . NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. Component Model Number(s) Nevro IPG(s) NIPG1000,. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. I am. 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 has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. Use only product literature from the region where the procedure was performed. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hemorrhage/Bleeding (1888). 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. Resources for radiology and pain management clinicians whose patient has a Medtronic spinal cord stimulation system and requires an MRI scan. NEVRO CORP. Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. 1. 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);. There were no reports of device-related issues from the patient prior to the passing. 00 per kit. D. NEVRO CORP. 5 cycle of Nevro SCS system requires continued voltage variations operation during power mains interruptions, it is on power supply 40 % UT 40 % UT recommended that the Nevro SCS system be input lines IEC (60 % dip in UT) (60 % dip in UT) powered from an uninterruptible power supply or 61000-4. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Complaint, Ill-Defined (2331); Inadequate Pain. Nevro Corporation. All questions or concerns about Nevro Corp. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. and is capable of stimulating the spinal cord nerv es when used with one or more leads. 2. q4cdn. Nevro attempted to obtain additional information regarding the nature of the issues, but. Nevro has complied with regulatory investigation requirements and is submitting all. , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. 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. 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. Nevro has complied with regulatory investigation requirements and is submitting all information. Read. 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. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Convulsion/Seizure (4406) Event Date 12/01/2021: Event Type Injury Event Description It was reported that the patient experienced seizures. Setup instructions, pairing guide, and how to reset. Use only product literature from the region where the patient procedure was performed. Neurostimulation System: Senza Spinal Cord Stimulation System. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. Nevro attempted to obtain a medical assessment from a healthcare professional but no additional information was available. 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. 2 W/kg head SAR, and up to 80% of the PNS limit). a different manufacturer attached to the Nevro IPG. 1800 Bridge Parkway . 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 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. products should be forwarded to: Nevro Corp. 0005 . Please note that product literature varies by geography. 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 01/11/2021: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed and no issues were. However, we may not have been able to confirm this information. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. 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 Wound Dehiscence (1154) Event Date 01/24/2022: Event Type Injury Event Description It was reported that a patient was experiencing wound dehiscence issue. com Description Implantable Pulse Generator Article Number NIPG3000 Pieces per pack 1 Packaging Size 8. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hematoma (1884) Event Date 09/20/2019: 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 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 Insufficient Information (4580) Event Date 02/08/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. 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 has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this. NEVRO CORP. Primary ID Brand Name Company Name Version or Model GMDN Terms Device ID a0379068-a2f1-41ec-887e-bf4cb73dbeaa Nevro® NEVRO CORP. NEVRO CORP. Expired » Nevro » Neuromodulation. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. NEVRO CORP. NEVRO CORP. Manuals are subject to change; the most current version is available on this. Please note that the following components of the Senza system are . 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 02/01/2019: Event Type Death Manufacturer Narrative A review of the complaint record has found no other instances of similar events. 650. 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 Nevro Senza Spinal Cord Stimulator ‐ MRI available Mon‐Fri, 8am‐5pm; Univ Hospital Only. 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,. It was reported to nevro that the patient¿s arm was making uncontrolled movements and the patient was hospitalized. Redwood City, CA 94065 USA . 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. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel:. 1800 Bridge Parkway . NEVRO CORP. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Hypertension (4460). 251. 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 Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). It was reported to nevro that the patient developed an infection at the battery site. 1800 Bridge Parkway Redwood City, CA 94065 USA 1. (b)(6) determined a defective bracket that held the lead caused the spinal cord stimulator to malfunction, causing the stimulator to stop working. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 01/27/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. It was reported to nevro that a patient had acquired an infection following a permanent implant. ,ACCK9050,Electrosurgical cable. I componenti MR Conditional del sistema Senza . NEVRO CORP. 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 Unspecified Infection (1930) Event Date 06/22/2016: Event Type Injury Manufacturer Narrative. Figure 1: Head MRI scans are permissible using 1. It was reported to nevro that the patient was admitted to hospital for breathing difficulties and passed away shortly after. NEVRO CORP. (NYSE: NVRO), a. 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 08/05/2019: Event Type Injury Manufacturer Narrative Nevro is awaiting the return of the device. NEVRO CORP. Nevro >. Certain Abbott neurostimulation systems are MR Conditional with 1. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). It was reported to nevro that the patient passed away. 251. NEVRO CORP. Global Unique Device ID: 00813426020015. NEVRO CORP. When his doctor recommended an HFX trial, he figured it was worth a shot. 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 Death (1802) Event Date 07/15/2019: 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 Insufficient Information (4580) Event Date 08/01/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. 11096 Rev G 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 09/10/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed, and no non-conformities were. . The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. 5’ x 15. 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. There were no reports of device-related issues from the patient prior to the. 10001162 Rev B 6 2. The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. Cargo or 12-seat passenger van. Expanding Patient Access to Nevro's HF10® Therapy Through Broader Imaging Compatibility Nevro Corp. 888. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pneumonia (2011). It was reported to nevro that a patient experienced swelling over the ipg site following the implant procedure. 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 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. The risk of using other types of RF coils has not been evaluated. 2015. 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 Problem Arrhythmia (1721). Learn more about HFX iQ. S. See. 1500 IPG NEUROSIS WITHOUT. 5. 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. NEVRO CORP. Leitlinien zur MRT bei 1,5 T und 3 T für das Senza-System 11095-GER Rev. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 02/08/2021: Event Type Death Manufacturer Narrative Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) : Patient Problem Skin Erosion (2075): Event Date 02/24/2021: Event Type Injury 11096 Rev F. 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). Nevro had attempted to obtain additional information regarding the nature of the issue but was unsuccessful. Redwood City, CA 94065 USA . Company Name: NEVRO CORP. Variant information Shape - square€NIPG1000 - Square header Shape - round€NIPG1500 - Rounded headerNevro hereby declares that the Senza® system is in compliance with the essential requirements and other relevant provisions of the R&TTE Directive (1999/5/EC). 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 IPG is. 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). On September 17, 2017, based on the representations of Dr. The physician stated that there was no infection and no antibiotics were given to the patient. Lead is a thin. IPG1500 User Manual PDF Version. 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. It was reported to nevro that the patient was in a rehabilitation facility. 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. 9415 [email protected] or Model: NIPG1500. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. NEVRO CORPORATION: Date Received: 2019-05-24:. (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. 9415 info@nevro. The manufacturing records were reviewed and no relevant nonconformities were found. Nevro attempted to obtain additional information regarding the nature of the device removal but was [email protected] CORP. Please note that product literature varies by geography. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 11/15/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. Request A Paper Manual. NEVRO CORP. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 01/15/2022: Event Type Death Event Description It was reported that the patient passed away. (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. Posted by. HFX has a similar safety profile, including side effects and risks, to other. 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 Pain (1994) Event Date 08/12/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. On (b)(6) 2018 stimulator was not working properly, dr. Nevro attempted to obtain a medical assessment from the physician but no additional information was available. It was reported to nevro that the patient passed away due to complications following a leg amputation related to.