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 Skin Erosion (2075) Event Date 07/01/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. 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). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Embolism (1498) Event Date 01/24/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Renal Failure (2041) Event Date 11/08/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed, and no non-conformities were found. S. Nevro has complied with regulatory investigation requirements and is submitting. , lumbar, truncal, in a limb). Nevro Corporation. (b)(6) determined a defective bracket that held. NIPG1000 o NIPG1500). SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 06/26/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. NEVRO CORP. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. NEVRO CORP. Introduction Nevro® SENZA®, SENZA II®, and SENZA Omnia™ Spinal Cord Stimulation (SCS) systems are MR Conditional devices that have been demonstrated to present no known hazards in a specified MR environment when following specific guidelines as described in this document. • 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). NEVRO CORP. (3T has severe limitations. It was reported to nevro that the patient experienced a stroke and a seizure. 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 Skin Erosion (2075); Pressure Sores (2326) Event Date 02/03/2022: Event Type Injury Manufacturer Narrative. If the user interruptions and for 0. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. 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). 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 Problems Unspecified Infection (1930); Sepsis (2067) Event Date 06/12/2019: Event Type Injury Manufacturer Narrative. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Aspiration/Inhalation (1725); Vomiting (2144) Event Date 08/09/2016:. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 01/13/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. However, we may not have been able to confirm this information. Version (Model) Number: NIPG1500. NEVRO CORP. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. registered trademarks owned by Bluetooth SIG, Inc. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. 0005 Fax: +1. The battery lights will continue to flash. “Now I have an active lifestyle for the first time since I was in my 30s. Safety Info ID#. 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 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. connect to the implan ted IPG. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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. All questions…Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Every person is unique and your medical needs differ from those of others, even people with the same condition and the same SCS system. It was reported to nevro during a patient's follow up that a patient had acquired an infection 4 months post implant. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Follow up report indicated that the infection has cleared and the patient had recovered without sequelae. This Reimbursement Guide is an interactive PDF covering the common questions and barriers of reimbursement including the following sections: Coverage – Includes a Medicare Coverage Map and details on requirements of psychological evaluations and surgical consultations. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 12/25/2020: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Skin Erosion (2075) Event Date 02/24/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 05/20/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Surgery on (b)(6) 2018 for the removal of lead, battery, and bracket and replacement of lead. Due Apr 24, 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 05/28/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. NEVRO CORP. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. Nevro attempted to obtain additional information regarding the nature of the incident but was unsuccessful. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. , 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 Complaint, Ill-Defined (2331) Event Date 08/06/2020: Event Type Injury Manufacturer Narrative The device was returned and analysis is currently in progress. a different manufacturer attached to the Nevro IPG. 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 08/12/2019: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4). NEVRO CORP. NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE. High roof or standard roof. g. 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. q4cdn. The risk of using other types of RF coils has not been evaluated. Company Announces Preliminary, Unaudited Second Quarter 2021 Revenue of Approximately $102. Nevro attempted to obtain more information regarding the nature of the issue, but none was available. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Hypertension (4460). 0 Tesla MRI scanners. NEVRO CORP. NEVRO CORP. : LEAD10 × 8-xxB Senza NIPG1000 or NIPG1500 Head/knee/ wrist-only 1. It was reported to nevro that the patient was hospitalized. The work will be performed at 34800 Bob Wilson Dr, San. Use only product literature from the region where the procedure was performed. Commercial Distribution Status: In Commercial Distribution. inside the body (see IPG in the diagram above). Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro’s system is the only device on the market that should be billed with C1822. Tatevossian and Defendant Greg Khougarnian, M. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 . Nevro Corporation Senza Implantable Pulse Generator Users Manual. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Muscular Tics (2161). 3 Million and Plans to Update Guidance When It Reports Second Quarter 2021 Financial Results on August 4, 2021 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. All questions or concerns about Nevro Corp. NEVRO CORP. Trade name. 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. “Now I have an active lifestyle for the first time since I was in my 30s. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. 0005 The Senza System has a very similar safety profile to other SCS devices that have been available for many years. 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. 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. Setup instructions, pairing guide, and how to reset. It was reported to nevro that the patient acquired an infection at the pocket site. On September 17, 2017, based on the representations of Dr. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Wound Dehiscence (1154); Impaired Healing (2378). UserManual. “Now I have an active lifestyle for the first time since I was in my 30s. I componenti MR Conditional del sistema Senza . Please note that MR Conditional components of the Senza system do not include The trial stimulator (TSM), patient remote, charger, surgical accessories, programmer wand, and clinician programmer. Nevro attempted to obtain additional information regarding the nature of the surgery but was. 650. Nevro Corp. Redwood City, CA 94065 USA . Important safety, side effects, and risks information. All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). This Reimbursement Guide is an interactive PDF covering the common questions and barriers of reimbursement including the following sections: Coverage – Includes a Medicare Coverage Map and details on requirements of psychological evaluations and surgical consultations. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Irritation (1941); Complaint, Ill-Defined (2331) Event Date 05/08/2020: Event Type Injury Manufacturer Narrative. The manufacturing records were reviewed and no issues were found related to the nature of the complaint. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). 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 Death (1802) Event Date 12/29/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. NEVRO CORP. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 01/19/2021: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed and no issues were. Safety Topic / Subject. 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. User manual instruction guide for Senza Implantable Pulse Generator IPG1500 Nevro Corporation. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Paralysis (1997); Numbness (2415). 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). Nevro attempted to obtain a medical assessment from the physician but no additional information was available. 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 03/31/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. 1. The physician believes this was due to being a smoker and non-compliance with. Please note that the following components of the Senza system are . It was reported to nevro that the patient passed away due to complications from pneumonia. , 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 Problems Burning Sensation (2146); Reaction (2414); Electric Shock (2554). It was reported to nevro that the patient fell several times and felt their legs had weakened. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. (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. NEVRO CORP. S. Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. 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. NIPG1500 Analgesic spinal cord electrical stimulation system (36007) Primary: 00813426020015 36007 Obsolete False cff739ed-d67c-4c70-9456-987f754ece45 Senza® NEVRO CORP. ). Nevro attempted to obtain additional information regarding the nature of the rehabilitation facility stay but was. 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. The physician stated that there was no infection and no antibiotics were given to the patient. 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. Tatevossian and Defendant Greg Khouganian, M. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). Nevro has complied with regulatory investigation requirements and is submitting all information. NEVRO CORP. For example, the grantee code for FCC ID: XKYIPG1500 is XKY. Product Sizes: Size Type: N/S (NOT SPECIFIED) Dimension type for the clinically relevant measurement of the medical device. 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. Trade name. ACCK8012-70 Central nervous. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. Product Manuals for Patients. 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 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 the patient¿s incision site was not healing well and opening up. 11096 Rev F. It was noted that the patient had a pre-existing condition that limited their mobility. Use only product literature from the region where the patient procedure was performed. . The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Stroke/CVA (1770); Seizures (2063). Certain Abbott neurostimulation systems are MR Conditional with 1. It was reported to nevro that a patient experienced swelling over the ipg site following the implant procedure. NEVRO CORP. During a routine call from a nevro representative, it was reported that a patient's device had been explanted due to infection. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Spinal Cord Injury (2432). Product Code. 0005 Fax: +1. Posted Apr 19, 2018. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. The Senza syste m components will include: Implantable pulse generator (IPG) is a small, battery-powered electronic device that is implanted. The medical device IPG OMNIA NEVRO WITHOUT is realized by NEVRO CORP. It was reported to nevro that the patient experienced a hemorrhage requiring surgical intervention. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xxB: LEAD1058-50B, LEAD1058-70B, LEAD1058-90B Surpass® Surgical. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. Please note that the following components of the Senza system are . NEVRO CORP. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this. 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1. NEVRO CORP. NEVRO CORP. 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 Insufficient Information (4580) Event Date 08/01/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hematoma (1884) Event Date 07/01/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Do not bring these. NEVRO CORP. V-6 or V-8 power. 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. 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. HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment of 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 03/15/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. The IPG is. 00 per kit. 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. Nevro has complied with regulatory investigation requirements and is submitting all information. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 01/30/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient 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. Catalog Number: NIPG1500. Contact Phone Extension: 6502510005: Phone Extension for the Customer contact. NEVRO SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results:. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. Published May 8. NIPG3000 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Primary: 00813426020718 fc61bdbc-e0e9-4783-8f18-90562bd3d230 Senza. Sign in to add this product to your favorites! Price: $3,530. 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. 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. 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. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. MR Unsafe: • You have a Nevro spinal cord stimulator • If you have any other medical device implants • A detailed description of your devices, including the product number of the implant, leads, and other implanted components • The contact information of the doctor who implanted your device Nevro Corp. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). Dismiss the beeping by pressing and holding the ON/OFF Button for up to 5 seconds. Use only product literature from the region where the patient procedure was performed. The device was removed and the patient was discharged and is currently recovering. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). Instead of worrying about how to relieve my pain. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 12/01/2019: Event Type Injury Event Description It was reported that the patient's device was removed. 5T Highly Preferred. 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 has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. Nevro attempted to obtain additional information regarding the nature of the infection, but none was available. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. For example, the grantee code for FCC ID: XKYIPG1500 is XKY. 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. D. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Fall (1848); Muscle Weakness (1967). MR Unsafe:AccessGUDID - Omnia (00813426020572)- Senza Omnia IPG Kit An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 01/11/2022: Event Type Injury Manufacturer Narrative. Federal Contract Opportunity for Nevro Corps IPG Kit N0025918N0050. 5’ Patient Contact Material Titanium, Silicone rubber, Epoxy Product Specifications Product Specification SheetNEVRO CORP. SENZA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number NIPG1500: Device Problem Insufficient Information (3190) Patient Problems Purulent Discharge (1812); Erythema (1840); Necrosis (1971); Pain (1994); Swelling (2091)NEVRO CORP. On September 17, 2017, based on the representations of Dr. Nevro attempted to obtain additional information regarding the nature of the device removal but was [email protected] CORP. 5T or 3T transmit / receive RF head coil, as long as the implanted Nevro Senza system components are not within the transmit / receive. Nevro attempted to obtain additional information regarding the nature of the device removal but none 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 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. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD1058-xx(B): LEAD1058-50(B), LEAD1058-70(B), LEAD1058-90(B) Surpass™. D. Please note that the following components of the Senza system are . The physician noted that the patient has a pre-existing autoimmune disease making her more susceptible to. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns. The medical device 1500 IPG NEUROSIS WITHOUT is realized by 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 Convulsion/Seizure (4406) Event Date 01/10/2022: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. Product Manuals for Healthcare Professionals. The safety of HFX has been thoroughly studied and proven. Contact your Nevro HFX Care Team. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Nausea (1970); Seizures (2063). delivering stimulation. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. 11096 Rev G 5. The device was explanted. 251. Notable features in 2015: New SL trim level for cargo van. , et al. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 10/16/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. NEVRO CORP. 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. NEVRO SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results:. The report also indicated that the patient is immuno-suppressive due to a kidney transplant. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient 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. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 09/28/2018: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. It was reported to nevro that a patient in (b)(6) had acquired an infection following a revision procedure. Die Bluetooth®-Wortmarke und -Logos sind eingetragene Marken von Bluetooth SIG, Inc. See. 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. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. NEVRO CORPORATION: Date Received: 2019-05-24:. NIPG1500: Device Catalogue Number. 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 08/03/2022: Event Type Death Event Description It was reported that the patient passed away. NEVRO CORP. It was reported to nevro that the patient was admitted to hospital for breathing difficulties and passed away shortly after. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Embolism (1498) Event Date 01/24/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930) Event Date 01/01/2019: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. 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 Cerebrospinal Fluid Leakage (1772); Pain (1994); Scar Tissue (2060); Spinal Cord Injury (2432) Event Date 07/08/2020:NEVRO CORP. THE List. 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 01/27/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues related to the nature. , mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for. 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 Problems Death (1802); Pneumonia (2011). It was reported to nevro that the patient experienced spasms following the implant procedure. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 10/23/2018: Event Type Death Manufacturer Narrative The device was returned and analyzed. 1800 Bridge Parkway . Company Name: 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 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. NEVRO CORP. 9415 [email protected] or Model: NIPG1500. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Death (1802) Event Date 02/01/2019: Event Type Death Manufacturer Narrative A review of the complaint record has found no other instances of similar events. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. Quick, outpatient & minimally invasive. 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 Unspecified Infection (1930). CE Mark effective on 4 May 2010 . Nevro attempted to obtain a medical assessment from the physician but no additional information was available. The short answer is yes, it’s possible but- it depends on which spinal cord stimulator device you choose. 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 Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 12/01/2019: Event Type Injury Event Description It was reported that the patient's device was removed. NEVRO CORP. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. Learn more about HFX iQ. NEVRO CORP. 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);. 1. NEVRO CORP. IMPORTANT: Do not change or modify any component of the Nevro® Senza system, unless expressly approved by Nevro Corp. 187. 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). Model Number NIPG1500: Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191). 47909). Instead of worrying about how to relieve my pain. The report indicated that the patient has a history of (b)(6) and was diagnosed with acute kidney. NEVRO CORP. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). (NIPG1500, NIPG2000), Lead Extension kits (MADP2008-25B M8, SADP2008-25B S8), and Lead Adapter kits (LEAD2008-25B, LEAD2008-35B, LEAD2008-60B) of your. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. PRECAUTIONS. 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, SENZA, SENZA II, Omnia, SENZA Omnia, Senza Bluetooth®, Surpass, Surpass-C, HF10 und das Nevro-Logo sind Marken der Nevro Corp. It was reported to nevro that the patient developed an infection at the ipg site. 0 million in the prior. Minimal restrictions and reversible. The physician believes the cause of death was pneumonia and not device related. Quick, outpatient & minimally invasive. All Superiority and Paresthesia-free claims are supported by the Senza Summary of Safety and Effectiveness Data (SSED). 00 per kit In Stock: 0 kits: Status: expired: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). 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 Impaired Healing (2378) Event Date 01/31/2022: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities were found. Nevro had attempted to obtain additional information regarding the nature of the issue but was unsuccessful. Typically safer than other spine surgeries used to address chronic pain 1-5. a different manufacturer attached to the Nevro IPG. Please note that product literature varies by geography. It was reported to nevro that the patient passed away due to complications following a leg amputation 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 05/17/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Nevro attempted to obtain a medical assessment from a healthcare professional to confirm the cause of death but no additional information was available. Cargo or 12-seat passenger van. Contact your Nevro HFX Care Team. Nevro attempted to obtain additional information regarding the nature of the hospitalization but was unsuccessful. B Seite 5. 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. Important safety, side effects, and risks information. 15, 2017 /PRNewswire/ - Nevro Corp. 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 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. (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 Insufficient Information (4580) Event Date 03/28/2022: Event Type Death Event Description It was reported that the patient passed away. Nevro Corporation. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). There were no reports of device-related issues from the patient prior to the. D. 2.