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. Manuals are. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. Version (Model) Number: NIPG1500. 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 Pulmonary Embolism (1498) Event Date 01/24/2022: 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 Problems Nausea (1970); Seizures (2063). 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. 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. 1. 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. Brand Name: Senza® . 2015. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). NEVRO CORP. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel:. 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). 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. Product Code. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. The risk of using other types of RF coils has not been evaluated. 251. 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. , et al. 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 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Muscular Tics (2161). It was reported to nevro 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 Insufficient Information (4580) Event Date 12/01/2019: Event Type Injury Event Description It was reported that the patient's device was removed. Typically safer than other spine surgeries used to address chronic pain 1-5. 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. 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. Primary DI Number: 00813426020015 Issuing Agency: GS1 Commercial Distribution End Date: Device Count:. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). 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. Posted by the Bureau of Medicine and Surgery (DOD - Navy). With respect to CRPS, I would be wary that the implant has less proven effectiveness than with actual spinal issues - my personal belief is that the CRPS my wife has may be neurological but NOT spinal. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Burning Sensation (2146); Reaction (2414); Electric Shock (2554). (b)(6) determined a defective bracket that held. modello: MADP2008- xxB). I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. Follow up report indicated that the infection has cleared and the patient had recovered without sequelae. NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE. It was reported to nevro that a patient in (b)(6) had acquired an infection following a revision procedure. During a routine call from a nevro representative, it was reported that a patient's device had been explanted due to infection. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Nevro attempted to obtain additional information regarding the nature of the device removal but was [email protected] CORP. Product Code Description Revenue Code HCPCS Code NIPG1000 or NIPG1500 or NIPG2500 IPG Kit 278 C1822 CHGR1000 or CHGR2500 Charger Kit 278 C1822 Most commercial plans provide guidance in their medical policies about which device HCPCS codes to report on claims. 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 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 FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. It was reported to nevro that the patient was hospitalized. Trade name. NIPG1500 Analgesic spinal cord electrical stimulation system (36007) Primary: 00813426020015 36007 Obsolete False cff739ed-d67c-4c70-9456-987f754ece45 Senza® NEVRO CORP. It was reported to nevro that the patient passed away due to complications from pneumonia. 1500 IPG NEUROSIS WITHOUT. View 2015 model details Shop Now. 47909). It was reported to nevro that the patient fell several times and felt their legs had weakened. g. I componenti MR Conditional del sistema Senza . It was reported to nevro that a patient experienced swelling over the ipg site following the implant procedure. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. 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 Death (1802) Event Date 06/26/2019: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). items on this form include forced-choice terms used by the fda for reporting purposes that do not necessarily reflect nevro¿s conclusions about the causes or nature of the event. 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 02/01/2019: Event Type Death Manufacturer Narrative A review of the available diagnostic data showed no indications of a device. One comprehensive solution for individualized relief of chronic pain that gives you more versatility than ever before. NEVRO CORP. org. 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. 1. 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. Please note that the following components of the Senza system are . 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. Search Alerts/Recalls. 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. Anesthesiology, 123(4) 2 Kapural L. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. Due Apr 24, 2018. 1. 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). Please note that product literature varies by geography. Use only product literature from the region where the patient procedure was performed. The medical device 1500 IPG NEUROSIS WITHOUT is realized by NEVRO CORP. However, we may not have been able to confirm this information. All questions…Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). Nevro attempted to obtain additional information regarding the nature of the numbness but was unsuccessful. Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. , Plaintiff went forward with surgery to surgically implant into his back the Nevro neurostimulator model NIPG1500 (serial no. NEVRO CORP. Nevro attempted to obtain additional information regarding the nature of the incident but was unsuccessful. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Safety Info ID#. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 06/06/2020: Event Type Death Manufacturer Narrative The date of death is estimated based on diagnostic data provided. The battery lights will continue to flash. NIPG1500: Nevro Senza Implantable Pulse Generator (IPG) Kit HF10. Catalog Number: NIPG1500 Company Name: NEVRO CORP. HFX has a similar safety profile, including side effects and risks, to other. The report also indicated that the patient is immuno-suppressive due to a kidney transplant. Primary ID Brand Name Company Name Version or Model GMDN Terms Device ID f417ce9f-5817-4688-b496-446369dcbd82 Senza NEVRO CORP. Novel 10-kHz High-frequency Therapy Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain. Avoid activities that put stress on the implanted neurostimulation system components. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. HFX Spinal Cord Stimulation is a nondrug, FDA-approved, treatment option for long-term chronic pain relief. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 . 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. Nevro and the specialist have been notably quieter since it was clear the implant was not a 'very' successful one, but they are still supportive. 2 NEVRO CORP. Federal Contract Opportunity for Neurostimulator Products N0025918N0060. It was reported to nevro that a patient was admitted to the er due to report of swelling in the foot and loss of coordination. 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. It was noted that the patient had been using the device with effective pain relief. 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 Problems Irritation (1941); Complaint, Ill-Defined (2331) Event Date 05/08/2020: Event Type Injury Manufacturer Narrative. com Description Implantable Pulse Generator Article Number NIPG3000 Pieces per pack 1 Packaging Size 8. Contact your Nevro HFX Care Team. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem 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 attempted to obtain a medical assessment from the physician but no additional information was available. 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. Figure 1: Head MRI scans are permissible using 1. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Unspecified Infection (1930). The Senza syste m components will include: Implantable pulse generator (IPG) is a small, battery-powered electronic device that is implanted. and any use of such marks by Nevro Corp. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). NEVRO CORP. 0005 Fax: +1. Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful. Please note that the following components of the Senza system are . 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 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. 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 Foreign Body Reaction (1868) Event Date 02/10/2021: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found. The Chronic Pain Solution The sum of excellence in four key. (NIPG1500, NIPG2000), Lead Extension kits (MADP2008-25B M8, SADP2008-25B S8), and Lead Adapter kits (LEAD2008-25B, LEAD2008-35B, LEAD2008-60B) of your. It was reported to nevro that the patient passed away. , lumbar, truncal, in a limb). (3T has severe limitations. Published May 8. 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 attempted to obtain additional information regarding the nature of the infection but was unsuccessful. Safety Topic / Subject. non. Sign in to add this product to your favorites! Price: $3,530. NIPG1500. Introduction Nevro® SENZA®, SENZA II®, and SENZA Omnia™ Spinal Cord Stimulation (SCS) systems are MR Conditional devices that have been demonstrated to present no known hazards in a specified MR environment when following specific guidelines as described in this document. Nevro has complied with regulatory investigation requirements and is submitting. NEVRO CORP. inside the body (see IPG in the diagram above). MR Unsafe: Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xxB: LEAD1058-50B, LEAD1058-70B, LEAD1058-90B Surpass® Surgical Lead LEAD3005-xxB: LEAD3005-50B, LEAD3005-70B, LEAD3005-90B Surpass-C™ Surgical Lead LEAD2005-xxB: LEAD2005-50B, LEAD2005-70B, LEAD2005-90B Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD1058-xx(B): LEAD1058-50(B), LEAD1058-70(B), LEAD1058-90(B) Surpass™ Surgical Lead LEAD3005-xx(B): LEAD3005-50(B), LEAD3005-70(B), LEAD3005-90(B) Surpass-C™ Surgical Lead LEAD2005-xxB: LEAD2005-50B, LEAD2005-70B, LEAD2005-90B then use the patient ID card to identify Nevro Corp as the manufacturer of the patient’s spinal cord stimulator system. 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. 47909). Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pulmonary Hypertension (4460). comSENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Inadequate Pain Relief (2388); Insufficient Information (4580) Event Date 03/01/2022: Event Type Injury Event Description It was reported that the patient's device was removed. 1800 Bridge Parkway . 1500 IPG NEUROSIS WITHOUT. The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. NEVRO CORP. 10001162 Rev B 6 2. 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Paralysis (1997); Numbness (2415). 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. 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 IPG is implanted in a subcutaneous pocket. The battery lights will continue to flash. “Now I have an active lifestyle for the first time since I was in my 30s. Every person is unique and your medical needs differ from those of others, even people with the same condition and the same SCS system. NEVRO CORP. Many of the Nevro HFX spinal cord stimulator reviews mention the lasting relief it has provided after decades of chronic pain. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). 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 Announces Participation in Upcoming Investor Conferences. Company Name: NEVRO CORP. 47909). 9415 info@nevro. Trade name: IPG OMNIA NEVRO WITHOUT: Product Code: NIPG2500: Manufacturer of the medical device: NEVRO CORP. 2 NEVRO CORP. Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility REDWOOD CITY, California , Nov. On (b)(6) 2018 stimulator was not working properly, dr. is under license. 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. On (b)(6) 2018 stimulator was not working properly, dr. NEVRO CORP. Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. The Senza and Senza II Systems are implantable systems and deliver stimulation using implantable leads. Request A Paper Manual. (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 07/01/2021: 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 02/01/2019: Event Type Death Manufacturer Narrative A review of the complaint record has found no other instances of similar events. 5. 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. All questions or concerns about Nevro Corp. IPG1500 User Manual PDF Version. and a rechargeable, implantable pulse generator (I PG). (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 08/06/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. 0005 The Senza System has a very similar safety profile to other SCS devices that have been available for many years. V-6 or V-8 power. It was reported to nevro that a patient had acquired an infection at the ipg pocket post implant. 251. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. Posted Mar 21, 2018. Photos are for illustration purposes only and may not depict the exact item. NEVRO CORP. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has received approval from the U. It was reported to nevro that the patient was hospitalized for seizures. Nevro attempted to obtain additional information regarding the nature of the infection, but none was available. 0005 . Physician Implant. HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment. NEVRO CORP. NEVRO CORP. 15, 2017 /PRNewswire/ - Nevro Corp. Contact your Nevro HFX Care Team. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. It was reported to nevro that the patient was admitted to hospital for breathing difficulties and passed away shortly after. Nevro attempted to obtain more information regarding the nature of the issue, but none was available. 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. 5 cycle of Nevro SCS system requires continued voltage variations operation during power mains interruptions, it is on power supply 40 % UT 40 % UT recommended that the Nevro SCS system be input lines IEC (60 % dip in UT) (60 % dip in UT) powered from an uninterruptible power supply or 61000-4. Nevro attempted to obtain a medical assessment from a. The Senza system components will include: ď ˇ Implantable pulse generator (IPG) is a small, battery-powered electronic device that is implanted inside the body (see IPG in the diagram above). Nevro attempted to obtain additional information regarding the nature of the issue but none was available. Component Model Number(s) Nevro IPG(s) NIPG1000,. D. 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 Complaint, Ill-Defined (2331) Event Date 08/06/2020: Event Type Injury Manufacturer Narrative The device was returned and analysis is currently in progress. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Abnormal Vaginal Discharge (2123). The risks of performing MRI scan with a Nevro IPG connected to a lead manufactured by a different company have not been evaluated. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Seroma (2069). . You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. The. 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 Death (1802): Event Date 04/10/2020: Event Type Death Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility REDWOOD CITY, California , Nov. a different manufacturer attached to the Nevro IPG. 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pocket Erosion (2013). Primary DI Number:. 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. 5T Highly Preferred. 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 Impaired Healing (2378) Event Date 01/31/2022: 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 10/23/2018: Event Type Death Manufacturer Narrative The device was returned and analyzed. 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. Manuals are subject to change; the most current version is available on this page. NEVRO CORP. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. 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. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. 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 04/13/2020: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. Minimal restrictions and reversible. Category Name: NEUROSTIMULATORS, SPINE, TOTAL-IMPLANTABLE: Category Code: J020202: Sign repertoire: Registered: Group of similar. The patient was hospitalized and the device was explanted. , 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 Insufficient Information (4580) Event Date 08/01/2021: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. Product Code. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580) Event Date 08/03/2022: Event Type Death Event Description It was reported that the patient passed away. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. delivering stimulation. “Now I have an active lifestyle for the first time since I was in my 30s. For example, the grantee code for FCC ID: XKYIPG1500 is XKY. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. 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). On September 17, 2017, based on the representations of Dr. ď ˇ Lead, instead of connecting to an external stimulator as occurred during the trial phase, will connect to the implanted IPG. NEVRO CORP. Read. Certain Abbott neurostimulation systems are MR Conditional with 1. Important safety, side effects, and risks information. It was reported to nevro that the patient experienced a hemorrhage requiring surgical intervention. products should be forwarded to: Nevro Corp. 251. D. NEVRO CORP. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. 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. 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. Typically safer than other spine surgeries used to address chronic pain 1-5. 0005 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);. SENZA NEVRO SENZA: Back to Search Results: Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Neurological Deficit/Dysfunction (1982); Reaction (2414) Event Date 05/14/2019: Event Type Injury Manufacturer Narrative. s28. The Senza Spinal Cord Stimulation (SCS) system is an implanted, rechargeable spinal cord stimulation system intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to. The 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). The device was removed and there have been no reports of. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Complaint, Ill-Defined (2331). Posted by. The Leads are for single use and interface with the IPG, Lead Extensio ns, OR Cable, and lead accessories. Nevro attempted to obtain additional information regarding the nature of the incident but was unsuccessful. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hypersensitivity/Allergic reaction (1907). 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. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Insufficient Information (4580). 2 W/kg head SAR, and up to 80% of the PNS limit). 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. 00 per kit. Nevro has complied with regulatory investigation requirements and is submitting all. If the user interruptions and for 0. NEVRO CORP. 00 per kit In Stock: 0 kits: Status: expired: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. 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). 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 Insufficient Information (4580) Event Date 01/15/2022: Event Type Death Event Description It was reported that the patient passed away. The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated. 650. ACCK8012-90 Central nervous system electrical stimulation system lead stylet Primary: 00813426020800 4f637b5f-6a9b-47ab-9590-27e6d809f553 Nevro® NEVRO CORP. Nevro attempted to obtain additional information regarding the nature of the device removal but none was available. NEVRO CORP. The NAICS Category is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. 1. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD1058-xx(B): LEAD1058-50(B), LEAD1058-70(B), LEAD1058-90(B) Surpass™. NEVRO CORP. then use the patient ID card to identify Nevro Corp as the manufacturer of the patient’s spinal cord stimulator system. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pocket Erosion (2013). There were no reports of device-related issues from the patient prior to the passing. 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 medical device IPG OMNIA NEVRO WITHOUT is realized by NEVRO CORP. NEVRO CORP. It was reported to nevro that the patient passed away two weeks after the implant procedure. 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 01/27/2020: Event Type Injury Manufacturer Narrative The manufacturing records were reviewed and no issues were found related to. (b)(6) determined a defective bracket that held the lead caused the spinal cord stimulator to malfunction, causing the stimulator to stop working. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System (LivaNova and Cyberonics, Inc. 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 Insufficient Information (4580) Event Date 01/30/2022: Event Type Death Manufacturer Narrative The manufacturing records were reviewed and no relevant nonconformities. Nevro, SENZA, SENZA II, Omnia, SENZA Omnia, Senza Bluetooth®, Surpass, Surpass-C, HF10 und das Nevro-Logo sind Marken der Nevro Corp. NEVRO CORP. 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 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 Unspecified Infection (1930) Event Date 07/07/2020: 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 Unspecified Infection (1930) Event Date 09/28/2018: Event Type Injury Manufacturer Narrative The manufacturing and sterilization records were reviewed, and no non. • Use only a transmit/receive RF head coil or transmit/receive RF local coil. Introduction Nevro® SENZA®, SENZA II®, and SENZA Omnia™ Spinal Cord Stimulation (SCS) systems are MR Conditional devices that have been demonstrated to present no known hazards in a specified MR environment when following specific guidelines as described in this document. Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR. NEVRO CORP. 5 cycle for 0. connect to the implan ted IPG. Please note that the following components of the Senza system are . 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,. Setup instructions, pairing guide, and how to reset. 1. NEVRO CORP. Contact Phone Extension: 6502510005: Phone Extension for the Customer contact. Please note that the following components of the Senza system are . (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or NIPG1500). NEVRO CORP. found. Photos are for illustration purposes only and may not depict the exact item. Nevro attempted to obtain additional information regarding the nature of the surgery but was. Surgery on (b)(6) 2018 for the removal of lead, battery, and bracket and replacement of lead. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. 1 Definitions of Terms • MR Conditional1: An item with demonstrated safety in the MR environment within defined conditions. Model Number NIPG1500: Device Problem Adverse Event Without Identified Device or Use Problem (2993. The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG.