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 03/07/2020: 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 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 Death (1802) Event Date 05/20/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. (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. S. The IPG is. 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. 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. 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. HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment. 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. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. 650. Published May 8. 0005 . 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. NEVRO CORP. Product Manuals for Healthcare Professionals. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 02/28/2020: 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 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. 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). Instead of worrying about how to relieve my pain. 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). 251. Preliminary, unaudited second quarter 2021 U. The work will be performed at 34800 Bob Wilson Dr, San. NEVRO CORP. 3 Million and Plans to Update Guidance When It Reports Second Quarter 2021 Financial Results on August 4, 2021 Nevro Corp. 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. . Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Arrhythmia (1721). , mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for. 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 07/27/2020: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. 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. Published May 8. 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 Complaint, Ill-Defined (2331); Inadequate Pain. 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. NEVRO CORP. HFX Spinal Cord Stimulation is a nondrug, FDA-approved, treatment option for long-term chronic pain relief. “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 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. 650. 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. NEVRO CORP. The patient is currently still using therapy and there have been no reports of further. a different manufacturer attached to the Nevro IPG. 5. 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. , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or NIPG1500). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Wound Dehiscence (1154) Event Date 01/24/2022: Event Type Injury Event Description It was reported that a patient was experiencing wound dehiscence issue. 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 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. 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1. Expanding Patient Access to Nevro's HF10® Therapy Through Broader Imaging Compatibility Nevro Corp. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Myocardial Infarction (1969); Cancer (3262). THE List. Company Announces Preliminary, Unaudited Second Quarter 2021 Revenue of Approximately $102. 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. (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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). NEVRO CORP. Minimal restrictions and reversible. Senza HFX iQ is the first. 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. (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. 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. NEVRO CORP. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this. Manuals are. It was reported to nevro that the patient's device was removed due to an emergency upper back surgery. PRECAUTIONS. ď ˇ Lead, instead of connecting to an external stimulator as occurred during the trial phase, will connect to the implanted IPG. 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 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. 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. It was reported to nevro that a patient experienced swelling over the ipg site following the implant procedure. S. 0005 1. It was noted that the patient had been using the device with effective pain relief. The device was removed and the patient was discharged and is currently recovering. Anesthesiology, 123(4) 2 Kapural L. Tatevossian and Defendant Greg Khouganian, M. 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. Manuals are subject to change; the most current version is available on this page. Visit: IMRSER. 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. We would like to show you a description here but the site won’t allow us. Certain Abbott neurostimulation systems are MR Conditional with 1. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. The device was ultimately removed due to patient non-compliance and the physician was. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 09/10/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed, and no non-conformities were. Nevro Corporation. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. 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:. 11096 Rev F. 11096 Rev G 5. Sign in to add this product to your favorites! Price: $3,530. See. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xxB: LEAD1058-50B, LEAD1058-70B, LEAD1058-90B Surpass® Surgical. (b)(6) determined a defective bracket that held. NEVRO CORP. COM: Phone number for the Customer contact; to be used by patients and consumers for device-related questions. There were no reports of device-related issues from the patient prior to the passing. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 06/26/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. . 47909). The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. 251. UserManual. 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. Nevro SCS3 Perc. Notable features in 2015: New SL trim level for cargo van. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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. All questions or concerns about Nevro products should be forwarded to: 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). Setup instructions, pairing guide, and how to reset. 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. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG. 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. 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) Event Date 06/22/2016: Event Type Injury Manufacturer Narrative. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. 5/ 3-tesla closed, horizontal bore 15 min active scan time; must have all components out of head coil; stimulation off LEAD2008-xxB (extension), ACCK5xxx (lead anchor) and ACCK7000 (IPG port plug) MRSENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331) Event Date 08/06/2020: Event Type Injury Manufacturer Narrative The device was returned and analysis is currently in progress. All 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). The manufacturing records were reviewed and no relevant nonconformities were found. On September 17, 2017, based on the representations of Dr. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. 251. NEVRO CORP. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. 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. Federal Contract Opportunity for Nevro Corps IPG Kit N0025918N0050. and is capable of stimulating the spinal cord nerv es when used with one or more leads. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). 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 Death (1802). All questions…Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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. 47909). The Nevro Leads are intended to be used with an IPG or Trial Stimulator for use in . Use only product literature from the region where the patient procedure was performed. 1500 IPG NEUROSIS WITHOUT. 0 Tesla MRI scanners. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. Nevro attempted to obtain additional information regarding the nature of the device removal but was [email protected] CORP. There were no reports of device-related issues from the patient prior to the passing. q4cdn. 650. NEVRO CORP. View 2015 model details Shop Now. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 08/01/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. Avoid activities that put stress on the implanted neurostimulation system components. 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. NEVRO CORP. Model Number NIPG1500: Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191). 5T closed bore scanners subject to conditions in the MRI Procedures Manual. The Senza and Senza II Systems are implantable systems and deliver stimulation using implantable leads. It was reported to nevro that the patient was in a rehabilitation facility. NEVRO CORP. Get your discussion guide to start a conversation with your doctor. 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 that the patient developed an infection at the battery site. S. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Death (1802); Pneumonia (2011). I am. NIPG1500. Einführung Das Senza-Rückenmarkstimulationssystem (Spinal Cord Stimulation System, SCS-System) von Nevro ist ein bedingt MR-sicheres (MR Conditional) Produkt, das in einem festgelegten MRT-Umfeld bei Einhaltung bestimmter Richtlinien gemäß. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Muscular Tics (2161). On (b)(6) 2018 stimulator was not working properly, dr. 2015. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Complaint, Ill-Defined (2331); Insufficient Information (4580). All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). Device Name: Senza® IPG Kit. Nevro attempted to obtain additional information regarding the nature of the issues, but. NEVRO CORP. Figure 1: Head MRI scans are permissible using 1. MR Unsafe:Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 07/20/2016: Event Type Injury Manufacturer Narrative. Nevro 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. 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. Please note that the following components of the Senza system are . NEVRO CORP. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Primary ID,Brand Name,Company Name,Version or Model,GMDN Terms,Device ID a35b370b-b73b-44e1-a121-dbdfa7a48be9,Nevro® ,NEVRO CORP. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. 1500 IPG NEUROSIS WITHOUT. Please note that product literature varies by geography. NIPG1000 Analgesic spinal cord electrical stimulation system (36007) Primary: 00813426020008 36007 Obsolete False 10b480bc-7cc2-4ec1-b41a. 650. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pneumonia (2011). 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. For example, the grantee code for FCC ID: XKYIPG1500 is XKY. 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. 1800 Bridge Parkway Redwood City, CA 94065 USA 1. The. 1 Definitions of Terms • MR Conditional1: An item with demonstrated safety in the MR environment within defined conditions. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. ACCK8012-70 Central nervous. 956. NEVRO CORP. 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:. Nevro-IPG NIPG1000, NIPG1500, NIPG2000, NIPG2500SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Electric Shock (2554) Event Date 07/03/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to the nature of. NEVRO CORP. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. NEVRO CORP. NEVRO CORP. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Bradycardia (1751); Unspecified Kidney or Urinary Problem (4503) Event Date 03/28/2023: Event Type Injury Manufacturer Narrative. Photos are for illustration purposes only and may not depict the exact item. The medical device 1500 IPG NEUROSIS WITHOUT is realized by NEVRO CORP. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Seizures (2063) Event Date 10/15/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed, and no non-conformities were. The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. Primary ID Brand Name Company Name Version or Model GMDN Terms Device ID f417ce9f-5817-4688-b496-446369dcbd82 Senza NEVRO CORP. Trade name: IPG OMNIA NEVRO WITHOUT: Product Code: NIPG2500: Manufacturer of the medical device: NEVRO CORP. 1. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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 Complaint, Ill-Defined (2331) Event Date 01/27/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Nevro has complied with regulatory investigation requirements and is submitting. 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. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); Pocket Erosion (2013) Event Date 01/28/2021: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 09/09/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. 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 Death (1802) Event Date 10/16/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Learn more about HFX iQ. 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). There were no reports of device-related issues from the patient prior to the. NEVRO CORP. Catalog Number: NIPG1500 Company Name: NEVRO CORP. HFX™ for PDN Now the Only Spinal Cord Stimulation System Approved by FDA to Treat PDN¹ Company Will Immediately Initiate Commercial Launch Activities in the U. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Hypertension (4460). Nevro Corp. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System, Neuromodulation System. 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). Every person is unique and your. NEVRO CORP. 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). Primary DI Number: 00813426020015 Issuing Agency: GS1 Commercial Distribution End Date: Device Count:. 1. 00 per kit. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. Please note that product literature varies by geography. The short answer is yes, it’s possible but- it depends on which spinal cord stimulator device you choose. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. Neurostimulation System: Senza Spinal Cord Stimulation System, 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 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. During a routine call from a nevro representative, it was reported that a patient had acquired an infection post implant. One comprehensive solution for individualized relief of chronic pain that gives you more versatility than ever before. 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. Primary DI Number:. Global Unique Device ID: 00813426020015. 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. Dismiss the beeping by pressing and holding the ON/OFF Button for up to 5 seconds. modello: SADP2008-xxB) e M8 (cod. Nevro attempted to obtain more information regarding the nature of the issue, but none was available. non. Die Bluetooth®-Wortmarke und -Logos sind eingetragene Marken von Bluetooth SIG, Inc. 1800 Bridge Parkway . (Model Nos: NIPG1000 or NIPG1500). , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. Contact your Nevro HFX Care Team. Minimal restrictions and reversible. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. 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. 2 W/kg head SAR, and up to 80% of the PNS limit). 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);. It was reported to nevro that a patient had acquired an infection at the ipg pocket post implant. Search Alerts/Recalls. Nevro attempted to obtain additional information regarding the nature of the issue but none was available. 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 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. NEVRO CORP. 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. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. then use the patient ID card to identify Nevro Corp as the manufacturer of the patient’s spinal cord stimulator system. products, including any serious incident that has occurred in relation to the device, should be forwarded to: Nevro Corp. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 10/23/2018: Event Type Death Manufacturer Narrative The device was returned and analyzed. 2 NEVRO CORP. NEVRO CORP. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Skin Erosion (2075) Event Date 02/24/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. During a routine call from a nevro representative, it was reported that a patient's device had been explanted due to infection. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. NEVRO CORP. NEVRO CORP. 0 million, an increase of 67% compared to $51. NEVRO CORP. We Believe True Innovation Transforms More Lives NEVRO CORP. g. 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. 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 Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) : Patient Problem Death (1802): Event Date 03/07/2020: Event Type Death 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 The manufacturing records were reviewed and no relevant nonconformities were found. 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). Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. The Chronic Pain Solution The sum of excellence in four key. 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 CORP. Posted by. 0005 Fax: +1. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Fall (1848); Muscle Weakness (1967). The leads were left in-situ for future reimplant. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. NEVRO CORP. Primary ID Brand Name Company Name Version or Model GMDN Terms Device ID a0379068-a2f1-41ec-887e-bf4cb73dbeaa Nevro® 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. Good News! Based on your survey responses, Nevro HFX TM could relieve your chronic pain. (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. Nevro Corp. NEVRO CORP. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. 0 million in the prior. 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 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 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. 1800 Bridge Parkway . 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802). NEVRO CORPORATION: Date Received: 2019-05-24:. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 10/22/2019: Event Type Death Manufacturer Narrative The device was not returned. 5T Highly Preferred. Posted Mar 21, 2018. NEVRO CORP. NEVRO CORP. Posted Apr 19, 2018. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient 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. 650. ‐ Low SAR mode; SAR set based on device instructions. Nevro has complied with regulatory investigation requirements and is submitting all information. , lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included. The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. It was reported to nevro that the patient had the device removed. Sign in to add this product to your favorites! Price: $3,530. The. Tatevossian and Defendant Greg Khouganian, M. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 06/01/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. It was reported to nevro that the patient developed an infection at the ipg site. It was reported to nevro that the patient experienced numbness in the arm. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel: +1. It was reported to nevro that the patient¿s incision site was not healing well and opening up. Tatevossian and Defendant Greg Khougarnian, M. and a rechargeable, implantable pulse generator (I PG). 650. 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 Insufficient Information (4580) Event Date 01/15/2022: Event Type Death Event Description It was reported that the patient passed away. The patient was hospitalized and was given iv antibiotics. 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. 1 Kapural L. 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 06/12/2020: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. 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 Impaired Healing (2378) Event Date 03/15/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature of the. On September 17, 2017, based on the representations of Dr. NEVRO CORP. ACCK8012-90 Central nervous system electrical stimulation system lead stylet Primary: 00813426020800 4f637b5f-6a9b-47ab-9590-27e6d809f553 Nevro® NEVRO CORP. 47909). NEVRO CORP. The patient continues to use their device with effective pain relief. For example, the grantee code for FCC ID: XKYIPG1500 is XKY. Nevro hereby declares that the SENZA®, SENZA II®, SENZA Omnia™ is in compliance with the essential. 00 per kit. The physician stated that there was no infection and no antibiotics were given to the patient. a different manufacturer attached to the Nevro IPG. It was reported to nevro that the patient passed away. Product Code. 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 has complied with regulatory investigation requirements and is submitting. Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery.