INFORMATION FOR PRESCRIBERS Senza® Bluetooth® Trial System Effective November 2020 10001045 Rev B
All questions or concerns about Nevro Corp. products, including any serious incident that has occurred in relation to the device, should be forwarded to: Nevro Corp. 1800 Bridge Parkway Redwood City, CA 94065 USA Tel: +1.650.251.0005 Fax: +1.650.251.9415 info@nevro.com MDSS GMBH Schiffgraben 41 D-30175 Hannover Germany Australian Sponsor Emergo Australia 201 Sussex Street, Darling Park, Tower II, Level 20 Sydney, NSW 2000 Australia © Copyright 2020, Nevro Corp. All rights reserved.
CONTENTS 1 DEVICE AND PRODUCT DESCRIPTION ........................................................................................................................... 5 1.1 MAJOR COMPONENTS ............................................................................................................................................................ 5 1.2 SURGICAL ACCESSORIES ...........................................................................................................................................
6.13 INFECTION ........................................................................................................................................................................ 20 6.14 LONG‐TERM EFFECTIVENESS OF SPINAL CORD STIMULATION ...................................................................................................... 20 6.15 MOBILE PHONES AND OTHER BLUETOOTH®‐ENABLED DEVICES.................................................................................................... 20 6.
1 DEVICE AND PRODUCT DESCRIPTION The Nevro® Senza® BLUETOOTH® enabled Spinal Cord Stimulator (SCS) Trial System works by delivering electrical energy from a stimulator to an area around the spine. The system is capable of delivering HF10® therapy, a therapy that does not produce tingling sensations called paresthesia. It is also capable of providing stimulation that produces paresthesia at some therapy settings.
Battery Compartment Stimulation OFF Button 2 AAA Batteries Leads: Leads are thin insulated wires that connect to the Trial Stimulator at one end and have small electrodes on the other end placed near the spine. A small amount of electrical energy from the device travels through the leads and to the electrodes near the spine. 1.
Part Number Name Description TLEAD1058-xx Trial Percutaneous Lead Kit 1x8, 5 mm spacing xx = 50, 70, and 90 cm lengths LEAD1058-xx Percutaneous Lead Kit 1x8, 5 mm spacing xx = 50, 70, and 90 cm lengths LEAD3005-xx Surpass Surgical Lead Kit 2x8 paddle xx = 50, 70, and 90 cm lengths LEAD2005-xx Surpass-C Surgical Lead Kit 2x5 paddle xx = 70 and 90 cm lengths LEAD2008-xx Lead Extension Kit 1x8 extension xx = 35, 45, and 60 cm lengths MADP-25B M8 Adaptor Kit Medtronic lead adaptor, 25 cm SA
Competitor Leads Boston Scientific1 Adaptor Required None Compatible Leads SC-2016-xx Infinion™ 16 Lead and Splitter 2x8 Kit2 SC-2016-xxE Infinion 16 Lead and Splitter 2x8 Trial Kit SC-2138-xx Linear™ xxcm 8 Contact Lead SC-2158-xx Linear xxcm 8 Contact Lead SC-2158-xxE Linear xxcm8 Contact Lead SC-2208-xx Linear ST xxcm 8 Contact Lead SC-2218-xx Linear ST xxcm 8 Contact Lead SC-2218-xxE Linear ST xxcm 8 Contact Lead SC-2352-xx Linear 3-4 xxcm 8 Contact Lead SC-2352-xxE Linear 3-4 xxcm
2 INDICATIONS The Senza® Bluetooth® Trial System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: • Failed back surgery syndrome • Intractable low back pain • Leg pain INDICATIONS. Reasons to get a device, drug, or treatment. Indications are determined by medical experts, clinical studies, and the Food & Drug Administration (FDA).
3 CONTRAINDICATIONS The SCS System is contraindicated for the following patients: • Are poor surgical candidates • Are unable to operate the SCS system • Fail to receive effective pain relief during trial stimulation CONTRAINDICATIONS. Situations in which the device should not be used because the risk of use clearly outweighs any possible benefit. Contraindications are determined by medical experts, clinical studies, and the Food & Drug Administration (FDA).
4 WARNINGS WARNINGS. Statements about the use of the device that patients and doctors should take very seriously. If patients and doctor do not follow these warnings, it is possible that the patient could be hurt, and / or the device could be damaged. 4.1 Stimulation Frequencies Stimulation frequencies in the range of 2 Hz to 1,200 Hz are indicated for paresthesia-based therapy and the system must be configured to produce paresthesia.
Patients using the Senza® Bluetooth® Trial System that generates paresthesia (tingling sensations caused by stimulation) may choose to turn stimulation off to avoid uncomfortable sensations during sleep. Therapy at 10 kHz does not generate paresthesia and therefore stimulation can remain on during sleep. 4.
• Unexpected changes in stimulation, causing a momentary increase in stimulation or intermittent stimulation, which some patients have described as a jolting or shocking sensation. Although the unexpected change in stimulation may feel uncomfortable, it does not damage the device or injure the patient directly. In rare cases, as a result of the unexpected change in stimulation, patients have fallen and been injured.
5 WARNINGS ABOUT OTHER MEDICAL TREATMENTS There are some procedures that should not be performed or are not recommended for patients with the Senza® Bluetooth® Trial System and there are other procedures which may be possible only with certain precautions. Patients that need any of these treatments should discuss the treatment with their doctor and other clinicians (including dentists, physical therapists, occupational therapists) as well as with the medical personnel performing the procedure.
5.3 Computed Tomography Scans CT SCAN. A type of technology in which x-ray-like images are taken in sections (slices) and then re-assembled by computer to provide detailed two- and three-dimensional pictures of inside the body. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, its location relative to the programmed scan range.
ELECTROCAUTERY. The technique of burning the skin or flesh of a wound by means of an instrument heated by an electric current, typically to stop bleeding or prevent the wound from becoming infected. EXTERNAL DEFIBRILLATION. The emergency use of two large paddles placed on the chest to deliver a large amount of electrical energy to “re-start” the heart. LITHOTRIPSY. The use of sound waves to help break up calcified stones in the body. RADIATION. The use of radiation energy for therapy.
6 PRECAUTIONS PRECAUTIONS. Instructions about the device patients and doctors should follow to avoid damage to the device, so that it will function correctly and last longer. 6.1 Storage Store the Senza® Bluetooth® Trial System components and accessories at the prescribed temperatures, whether in transport or storage. Excessively hot or cold temperatures may damage the components, particularly high heat. Devices should be kept in temperature regulated areas within the acceptable temperature range.
Leads and lead extensions should always be handled with care. Do not make sharp bends to the lead or lead extension. Do not severely kink, crush or stretch the lead or lead extension. Do not apply severe torque (twist) to the lead or lead extension. Do not tie suture directly to the lead or the lead extension. When placing a suture around the lead, use the provided lead anchors. Do not force the lead into the epidural space.
Stimulation at 10 kHz does not generate paresthesia, so patients should not experience unpleasant sensations caused by posture changes or movement. As such, patients would not need to change amplitudes in their programs for posture changes or abrupt movements. 6.8 Patient Activities Related to Lead Movement Patients should not make sudden and excessive bending, stretching, or twisting movements.
6.12 Post-Operative Pain In the days after the surgery, patients may experience pain in the implant area. This is typical in SCS surgeries. 6.13 Infection If a patient experiences persistent discomfort or excessive redness around the wound areas, the patient may need to be checked for infection by their doctor. Infections related to the Senza® Bluetooth® Trial System may require the implanted components to be explanted. 6.
dispose of electrical components, including batteries, in the unsorted municipal waste stream. Dispose of electrical components, including batteries, according to local regulations. Whenever a lead or Trial Stimulator is removed from a patient and a product issue is suspected, it should be returned to Nevro Corp. This helps Nevro monitor its products and is required by U.S. law.
7 ADVERSE EVENTS Adverse events, or side effects, are risks associated with the use of the Senza® Bluetooth® Trial System or any other SCS system. There are adverse events associated with the lead implant procedure, with stimulation, and with the device itself. Patients should contact their doctor if they experience any adverse events associated with their device. 7.
• Failure or malfunction resulting in ineffective pain control or other undesirable changes in stimulation, and possibly requiring trial lead removal • Skin erosion or seroma at the lead site • Pressure sores • External sources of electromagnetic interference that cause the device to malfunction and could affect stimulation • Exposure to magnetic resonance imaging (MRI) can result in heating of tissue, image artifacts, induced voltages in the leads, and lead dislodgement • Infection • Epidural
8 TECHNICAL SPECIFICATIONS 8.1 Electromagnetic Interference Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Senza® Bluetooth® Trial System is intended for use in the electromagnetic environment specified below. The customer or user of the Senza® Bluetooth® Trial System should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Senza® Bluetooth® Trial System is intended for use in the electromagnetic environment specified below. The customer or user of the Senza® Bluetooth® Trial System should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Senza® Bluetooth® Trial System is intended for use in the electromagnetic environment specified below. The customer or user of the Senza® Bluetooth® Trial System should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance d=1.2 √ 80 MHz to 800 MHz d=2.3 √ 800 MHz to 2.
Recommended separation distances between portable and mobile RF communications equipment and the Senza® Bluetooth® Trial System The Senza® Bluetooth® Trial System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
8.2 FCC Statements Trial Stimulator FCC ID: XKYEXTS3000 Remote Control FCC ID: XKYPR1D3000 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
Parameter Range Frequency 2 – 10,000 Hz Pulse Width 20 – 1000 µs Amplitude 0 – 15 mA The following table summarizes the maximum amplitude, pulse width, and impedance at two frequency settings. Frequency* (Hz, Hertz) Maximum Amplitude (mA, milliamps) Maximum Pulse Width (µs, microseconds) Maximum Impedance (, Ohms) 2 9 1000 1000 10,000 10 30 1000 *Therapy settings between frequencies of 2 Hz -10 KHz can vary depending on actual values for Impedance, Current and Pulse Width 8.
9 SECURITY FEATURES AND DECLARATIONS 9.1 Wireless Security The Senza® Bluetooth® Trial System has a telemetry range of less than 5 feet (1.5 meters). The Remote Control is uniquely paired to a specific Trial Stimulator and can only communicate with that device. The Trial Stimulator will not respond to any communication that does not come from a linked device (a device that is paired with the Trial Stimulator). There are additional mechanisms that ensure the integrity of the communicated data.
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NEVRO CORP. All questions or concerns about Nevro Corp. products, including any serious incident that has occurred in relation to the device, should be forwarded to: Nevro Corp. 1800 Bridge Parkway Redwood City, CA 94065 USA Tel: +1.650.251.0005 Fax: +1.650.251.9415 Email: info@nevro.
