About This Manual
This document serves as the Physician Implant Manual for the Nevro Senza, Senza II, and Senza Omnia Spinal Cord Stimulation (SCS) Systems. These advanced neuromodulation devices are designed to provide electrical stimulation for the management of chronic intractable pain in the trunk and limbs.
Key Features and Components
The Nevro SCS systems consist of an implantable pulse generator (IPG), leads, a trial stimulator, a patient remote, and a clinician programmer. Each component plays a crucial role in delivering personalized pain relief. The manual details the system's components, including the IPG's rechargeable battery and output channels, the trial stimulator for evaluating therapy effectiveness, and the programmer for adjusting stimulation parameters.
Indications and Contraindications
The Senza systems are indicated for chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. For patients with diabetic neuropathy affecting the lower limbs, the system is also indicated when programmed with a 10 kHz frequency. Contraindications include poor surgical candidates, failure to achieve pain relief during trial stimulation, and inability to operate the system.
Important Safety Information
Physicians must adhere to the warnings and precautions outlined in this manual. This includes guidance on stimulation frequencies, use at specific vertebral levels, pediatric use, and potential interactions with other implanted devices. The manual also addresses safety considerations related to heat from charging, diathermy therapy, Computed Tomography (CT) scans, and Magnetic Resonance Imaging (MRI) procedures, emphasizing the importance of following specific guidelines for MR Conditional devices.
For detailed information on MRI safety and conditions, please refer to the Nevro MRI guidelines manuals available at www.nevro.com/physicianmanuals.
System Operation and Environment
The manual provides critical information regarding the use of the SCS system in hospital and medical environments, detailing potential risks associated with electrocautery, external defibrillation, lithotripsy, radiation therapy, and ultrasonic scanning. It also explains the potential for electromagnetic interference (EMI) from common sources and outlines precautions to mitigate these effects. Patients are advised to keep away from areas of strong EMI and to turn off the stimulator if necessary.
