BSNV-8 Adaptor Extension
1x8 adaptor extension kit
Instructions for use
Rx only
EMBSNV20
Explanation of symbols on product or package labeling
Refer to the appropriate product for symbols that apply.
See also the Neuromodulation Symbols Reference, which is provided with product labeling
at http://manuals.medtronic.com for explanation of other symbols on product and package
labeling.
Reference ISO 15223-1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1 and ASTM F2503 Part 13, Standard
Practice for Marking Medical Devices and Other Items for Safety in the Magnetic
Resonance Environment.
Magnetic Resonance (MR) Unsafe
ASTM F2503 [7.4.10]
Keep dry
ISO 15223-1 [5.3.4]
Keep away from sunlight
ISO 15223-1 [5.3.2]
EMBSNV20 2022-01-15 English 3
Medtronic and the Medtronic logo are trademarks of Medtronic.
Intellis™, Sequentia™, and Vanta™ are trademarks of a Medtronic company.
Third-party brands are trademarks of their respective owners.
4 English EMBSNV20 2022-01-15
Table of contents
Description 7
Intended purpose 7
Package contents 7
Compatibility 7
Contraindications 10
Warning – MRI eligibility 10
Warning – App version and MRI eligibility 10
MR Unsafe patient identification card 11
Cautions – Component handling 11
Device specifications 11
Instructions for use 13
Preparing for long-term system implant 13
Creating a pocket for the neurostimulator 13
Connecting system components to the adaptor for long-term system implant 14
Programming the system 16
Completing the implant procedure 17
Compatible leads and electrode numbering 17
Appendix: Trial procedures 21
Connecting the adaptor to the externalized lead or extension for the trial 21
Preparing components for the trial 22
Removing externalized components after the trial 23
EMBSNV20 2022-01-15 English 5
Information available for the system:
The information for prescribers manual provides information about
contraindications, warnings, precautions, adverse events,
sterilization, patient selection, individualization of treatment, and
component disposal. For customers in Japan, the appropriate
package insert provides information about safety, contraindications,
warnings, precautions, and adverse events.
The indications sheet provides information about indications and
related information. For customers in Japan, the appropriate
package insert provides information about indications.
The system eligibility and battery longevity manual describes
programming considerations and provides battery longevity
information to aid in the appropriate neurostimulator selection.
MRI guidelines provide information about any MRI conditions and
MRI-specific contraindications, warnings, and precautions for MRI
scans with the neurostimulation system.
Product manuals, such as programming guides, recharging guides,
and implant manuals provide device descriptions, package
contents, device specifications, product-specific warnings and
precautions, and instructions for use.
! USA
The clinical summary provides information about the clinical
study results for the neurostimulation system.
6 English EMBSNV20 2022-01-15
Description
The Medtronic Model EMBSNV20 1x8 BSNV-8 adaptor extension is part of a
neurostimulation system for pain therapy.
In this manual, “adaptor” is used to refer to the BSNV-8 adaptor extension. “Extension” is
used to reference any non Medtronic extensions that may be present in the system.
Intended purpose
The BSNV-8 adaptor extension is intended to connect specific Boston Scientific™ and
Nevro™ leads or extensions to specific Medtronic neurostimulators to conduct electrical
stimulation as part of a spinal cord stimulation (SCS) system for long-term system implant
or for use in test or trial stimulation.
Package contents
The adaptor extension and accessories are supplied sterile and are single-use only.
BSNV-8 adaptor extension
▪
Connector boots, 1 x 8 (1 clear, 1 white radiopaque)
▪
Spare setscrews (2)
▪
Torque wrench
▪
Product literature
▪
▪
Warranty card
▪
Registration form
Compatibility
Refer to Table 1 and Table 2 for adaptor compatibility information. Do not use products with
the Medtronic BSNV-8 adaptor that are not listed in Table 1 and Table 2.
EMBSNV20 2022-01-15 English 7
Table 1. Compatibility with the Medtronic BSNV-8 adaptor extension
Component Compatibility
Boston Scientific
Leads and
Extensions
Note: xx = length (cm), xxE = length (cm) Trial Lead.
SC-2138-xx Linear™ (8-contact)
▪
SC-2158-xx Linear (8-contact)
▪
SC-2158-xxE Linear (8-contact)
▪
SC-2208-xx Linear ST (8-contact)
▪
SC-2218-xx Linear ST (8-contact)
▪
SC-2218-xxE Linear ST (8-contact)
▪
SC-2408-xx Avista™ MRI (8-contact)
▪
SC-2352-xx Linear 3-4 (8-contact)
▪
SC-2352-xxE Linear 3-4 (8-contact)
▪
SC-2366-xx Linear 3-6 (8-contact)
▪
SC-2366-xxE Linear 3-6 (8-contact)
▪
SC-2016-xx Infinion™ 16-Contact Lead and Splitter 2x8 Kit
▪
SC-2016-xxE Infinion 16-Contact Lead and Splitter 2x8 Trial Kit
▪
SC-2316-xx Infinion 16-Contact Lead Kit
▪
SC-2316-xxE Infinion 16-Contact Lead Kit
▪
SC-2317-xx Infinion CX 16-Contact Lead kit
▪
SC-2317-xxE Infinion CX 16-Contact Trial Lead kit
▪
SC-8120-xx Artisan™ 2x8 Surgical Lead Kit
▪
SC-8216-xx Artisan 2x8 Surgical Lead Kit
▪
Note: Infinion leads require a compatible 2x8 splitter.
Extension and Splitter Models:
SC-3138 8-Contact Extension
▪
▪
SC-3400 Splitter 2x8
8 English EMBSNV20 2022-01-15
Loading...