1.5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza® System
Implantable components of Senza System have been approved for 1.5T and 3T MRI scans under specified conditions. The implanted components of the Senza System may include Nevro percutaneous leads (Model No.: LEAD10x8-xxB), surgical Lead (LEAD3005-xx(B), LEAD3015-xx(B), LEAD3025-xx(B)), lead extensions (Model No.: LEAD2008-xxB), lead anchors (Model No.: ACCK5xxx), IPG Port plug (ACCK7000), and the Senza implantable pulse generator (Model Nos: NIPG1000 or NIPG1500).
Please note that MR Conditional components of the Senza System do not include:
- The Trial Stimulator (EXTS1000), Patient Remote (PTRC1000 or PTRC2000), Charger (CHGR1000), surgical accessories, Programmer Wand (CLPW1000), and Clinician Programmer (CLPG1000 or CLPG2000). Do not bring these components into the MR scanner room.
- S8 lead adaptors (Model No.: SADP2008-xxB) and M8 lead adaptors (Model No.: MADP2008-xxB).
- Surgical lead (LEAD3005-xx(B), LEAD3015-xx(B), LEAD3025-xx(B))
The implanted Senza Spinal Cord Stimulation (SCS) system is MR Conditional and has been demonstrated to present no known hazards in a specified MR environment when following specific guidelines as described in the 1.5T and 3T Magnetic Resonance Imaging (MRI) Guidelines for the Senza System.
Please read the guidelines carefully on the conditions of use, risks, warnings, and instructions on using MRI with the Senza System. MR scans performed outside the guidelines may result in the MRI field interacting with implanted devices, potentially injuring the patient and damaging the implanted device.
This guideline is a supplement to the Senza System Physician Implant and Patient Manuals and is related only to use of a transmit/receive radio frequency (RF) head and transmit/receive RF volume coil of a 1.5T and 3T horizontal bore MRI system for patients implanted with the Senza System.