Boston Scientific Vercise User manual

Vercise™ Deep Brain
Stimulation Systems
Surgical Implant Manual
92495783-02
Content: MP92495783-02 REV A
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Vercise™ Deep Brain Stimulation Systems
Surgical Implant Manual
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How to Use this Manual
This manual describes the usage and implantation of the Boston Scientic Deep Brain Stimulation
(DBS) Systems. Read all instructions carefully before using the DBS Systems.
For indications for use, contraindications, warnings, precautions, adverse events, storage and
handling, sterilization, and warranty information refer to the DBS Information for Prescribers DFU.
For other device-specic information not included in this manual, refer to the appropriate DFU for
your Boston Scientic DBS System as listed in your DBS Reference Guide.
Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information relating
to its products in order to improve their reliability or operating capacity.
Drawings are for illustration purposes only. Note that not all drawings are to scale.
Trademarks
All trademarks are the property of their respective holders.
Contacting Boston Scientic
To contact Boston Scientic, see the “Technical Support” section of this manual.

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Product Model Numbers
You will only receive products appropriate for your region.
Model Number Description
DB-2201-XX-DC DBS Lead Kit, 30 cm or 45 cm
DB-2202-XX Vercise™ Cartesia™ 8 Contact DBS Directional Lead Kit, 30 cm or
45 cm
DB-4600-C Burr Hole Cover
DB-4605-C Burr Hole Cover Spares Kit
DB-2500-C Vercise™ Physician’s Spare Kit
NM-3138-55 8 Contact Lead Extension Kit, 55 cm
DB-3128-XX 2x8 Contact Lead Extension Kit, 55 cm or 95 cm
DB-5170 Vercise DBS External Trial Stimulator 3 (ETS 3)
DB-5132 Vercise DBS External Trial Stimulator 2 (ETS 2)
DB-4120-08 8 Contact Push-Button OR Cable
DB-4100-A; SC-4100-A 1x8 OR Cable and Extension
DB-9315 ETS Adapter
DB-1200 Vercise Gevia™ 16 Contact Implantable Pulse Generator Kit
DB-1140 Vercise PC™ Implantable Pulse Generator Kit
DB-1416 Vercise Genus™ P16 Implantable Pulse Generator Kit
DB-1432 Vercise Genus™ P32 Implantable Pulse Generator Kit
DB-1216 Vercise Genus™ R16 Implantable Pulse Generator Kit
DB-1232 Vercise Genus™ R32 Implantable Pulse Generator Kit
SC-4401 Port Plug, Spares
DB-4252; SC-4252 Straw Tunneling Tool, 28 cm
DB-4254; SC-4254 Long Tunneling Tool, 35 cm
SC-4275 Hex Wrench (Torque Wrench)
Note: XX = length (cm)

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Surgical Implant Manual
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Table of Contents
Product Kits ..................................................................................................1
Leads.................................................................................................................... 1
Lead Extensions ................................................................................................... 3
ETS and OR Cables ............................................................................................. 4
Implantable Pulse Generators .............................................................................. 5
Surgical Accessories ............................................................................................ 6
Burr Hole Cover .................................................................................................... 7
Product Descriptions ...................................................................................8
Device Descriptions and Technical Specications ............................................... 8
Standard Lead ...................................................................................................... 9
Directional Leads.................................................................................................. 10
Lead Extensions ................................................................................................... 11
Surgical Tools and Accessories ............................................................................ 13
External Trial Stimulators (ETS 2 and ETS 3) ...................................................... 17
Implantable Pulse Generators (IPGs) .................................................................. 18
DBS Product Compatibility..........................................................................22
Implanting the DBS System.........................................................................24
Pre-Conditions ...................................................................................................... 24
Securing the Base of the SureTek Burr Hole Cover ............................................. 25
Implanting the DBS Lead ..................................................................................... 26
Intraoperative Testing ........................................................................................... 28
Securing the DBS Lead ........................................................................................ 33
Tunneling the Lead Extension .............................................................................. 38
Connecting the DBS Lead to the Lead Extension ................................................ 40
Implanting the IPG................................................................................................ 43
Connecting to the IPG .......................................................................................... 46
Explanting or Replacing the DBS System..................................................50
Explanting the DBS System ................................................................................. 50
References....................................................................................................53
Technical Support ........................................................................................54

Product Kits
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Product Kits
Leads
Table 1: 8 Contact Lead Kits
Description Quantity
Lead with preloaded Straight Stylet 1
Torque Wrench 1
Lead Boot 1
Lead Stop – Screw and Ring 1
1 cm Suture Sleeve 1
1 cm Split Suture Sleeve 1
2.3 cm Suture Sleeve 1
4 cm Suture Sleeve 1
Note: All contents of the inner package or tray are sterile and non‑pyrogenic.
Table 2: 8 Contact Directional Lead Kits
Description Quantity
Directional Lead with preloaded Straight Stylet 1
Torque Wrench 1
Lead Boot 1
Lead Stop – Screw and Ring 1
1 cm Suture Sleeve 1
1 cm Split Suture Sleeve 1
2.3 cm Suture Sleeve 1
4 cm Suture Sleeve 1
Note: All contents of the inner package or tray are sterile and non‑pyrogenic.

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Surgical Implant Manual
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Table 3: Vercise Physician’s Spares Kit for 8 Contact Leads
Description Quantity
Lead Boot 1
Lead Stop – Screw and Ring 1
Torque Wrench 1
1 cm Suture Sleeve 1
1 cm Split Suture Sleeve 1
2.3 cm Suture Sleeve 1
4 cm Suture Sleeve 1
Note: All contents of the inner package are sterile.

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Lead Extensions
Table 4: 8 Contact Lead Extension Kits
Description Quantity
Lead Extension 1
Torque Wrench 1
28 cm Tunneling Tool Shaft (with Pre-Loaded Straw) 1
Tunneling Tool Handle 1
Note: All contents of the inner package or tray are sterile.
Table 5: 2x8 Contact Lead Extension Kits
Description Quantity
Lead Extension 1
Torque Wrench 1
Port Plugs 2
Note: All contents of the inner package or tray are sterile.

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Surgical Implant Manual
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ETS and OR Cables
Table 6: External Trial Stimulator Kit
Description Quantity
External Trial Stimulator 1
AA Batteries 2
Table 7: 8 Contact Push‑Button OR Cable
Description Quantity
OR Cable 1
Note: All contents of the inner package are sterile.
Table 8: 1x8 OR Cable
Description Quantity
OR Cable 1
OR Cable Extension 1
Note: All contents of the inner package are sterile.

Product Kits
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Implantable Pulse Generators
Table 9: 16 Contact Implantable Pulse Generator Kit
Description Quantity
Implantable Pulse Generator 1
Implantable Pulse Generator Template 1
Implantable Pulse Generator Port Plugs 2
Torque Wrench 1
Note: All contents of the inner package or tray are sterile.
Table 10: 32 Contact Implantable Pulse Generator Kit
Description Quantity
Implantable Pulse Generator 1
Implantable Pulse Generator Template 1
Implantable Pulse Generator Port Plugs 4
Torque Wrench 1
Note: All contents of the inner package or tray are sterile.
Table 11: Port Plug, Spares Kit
Description Quantity
Port Plugs 2
Note: All contents of the inner package are sterile.

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Surgical Implant Manual
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Surgical Accessories
Table 12: Tunneling Tool Kit
Description Quantity
Tunneling Tool Shaft (with Pre-Loaded Straw) 1
Tunneling Tool Handle 1
Note: All contents of the inner package are sterile.
Table 13: Hex Wrench Kit
Description Quantity
Torque Wrench 1
Note: All contents of the inner package are sterile.

Product Kits
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Burr Hole Cover
Table 14: Burr Hole Cover Kit
Description Quantity
Base and Bone Screws preassembled to Buttery Holding Tool 1
Retaining Clip 1
Cap 1
Placement/Removal Tool 1
Screwdriver 1
Note: All contents of the inner package (or tray) are sterile.
Table 15: Burr Hole Cover Spares Kit
Description Quantity
Bone Screws 1
Retaining Clip 1
Cap 1
Note: All contents of the inner package are sterile.

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Surgical Implant Manual
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Product Descriptions
Device Descriptions and Technical Specications
The implantable components of the Boston Scientic DBS System include the following:
• An Implantable Pulse Generator (IPG) that is either rechargeable or non-rechargeable
(also referred to as a Stimulator throughout this manual).
• Leads
• Lead Extensions that extend the Leads to the IPG
• A Lead Boot to protect the proximal end of the Lead between surgeries
• Sutures Sleeves to protect the Lead and/or to anchor the Leads and Lead Extensions
• The Boston Scientic SureTek™ Burr Hole Cover that may be used to anchor the Leads
The non-implantable components of the Boston Scientic DBS System include the following:
• An External Trial Stimulator (ETS) and OR Cables that may be used for intraoperative
testing
• A Tunneling Tool that is used to create a subcutaneous tunnel for the Leads and Lead
Extensions
• A Clinician Programmer that is used to set and adjust stimulation parameters
• External patient devices, such as the Remote Control that is used to communicate with
the IPG, and a Charging System (as applicable) to recharge the battery of rechargeable
IPGs

Product Descriptions
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Standard Lead
The Standard Lead consists of 8 cylindrical Contacts. The diameter of the Lead is 1.3 mm. The
Lead is compatible with existing commercially available DBS implantation tools.
Table 16: Technical Specications
Standard Lead (DB‑2201)
Feature Specication
Contact Length 1.5 mm
Contact Surface Area 6.0 mm2
Contact Spacing (axial) 0.5 mm
Array Span 15.5 mm
Distal Contact to Tip Length < 1.3 mm
Lead Diameter 1.3 mm
Overall Length 30 cm or 45 cm
Outer Tubing Material Polyurethane
Contact Material Platinum/Iridium
Impedance ≤ 90 Ω (measured from each connector to
corresponding electrode Contact)
Array Span
(15.5 mm)

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Surgical Implant Manual
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Directional Leads
The 8 Contact Directional Leads (see Table 17) have rows of Contacts that are segmented
circumferentially to allow both axial and rotational stimulation selectivity. Each segmented Contact
covers 90 degrees of the Lead circumference. Each Directional Lead has a radiopaque marker
whose solid portion aligns with Contact 2. The outer diameter of each Directional Lead is 1.3 mm.
The Directional Leads are compatible with existing commercially available DBS implantation tools.
Table 17: Technical Specications
8 Contact Directional Lead (DB‑2202, CartesiaTM)
Feature Specication
Contact Length11.5 mm
Ring Contact Surface Area 6.0 mm2
Segmented Contact Surface Area 1.5 mm2
Dome Tip Contact Surface Area 6.0 mm2
Contact Spacing (axial) 0.5 mm
Array Span 7.5 mm
Lead Diameter 1.3 mm
Overall Length 30 cm or 45 cm
Outer Tubing Material Polyurethane
Contact Material Platinum/Iridium
Impedance ≤ 90 Ω (measured from each connector to
corresponding electrode Contact)
1 Also applies to dome tip Contact.
Array Span
(7.5 mm) Radiopaque Marker

Product Descriptions
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Lead Extensions
The model of DBS Lead and position of the DBS IPG being implanted will determine the
compatible Lead Extension that should be used with that system. See the “DBS Product
Compatibility” section of this manual.
8 Contact Lead Extension
The 8 Contact Lead Extension consists of a Connector at the distal end and 8 cylindrical Contacts
at the proximal end. The Lead is inserted and secured into the Connector on the distal end. The
Connector also contains 8 Contacts that align with the Contacts on the Lead to form electrical
connections. The proximal end of the extension is inserted into the IPG.
The 8 Contact Lead Extension may only be used with 8 Contact Leads. Each of these Lead
Extensions connects to a single Lead. This 55 cm model is intended to support IPGs implanted in
the pectoral region.
Table 18: Technical Specications
8 Contact Lead Extension (NM‑3138)
Feature Specication
Overall Length 55 cm
Lead Extension Body Diameter 1.35 mm
Number of Contacts 8
Contact Material Platinum/Iridium
Insulation Material Polyurethane, Silicone
Setscrew Material Titanium
Proximal End
Distal End

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Surgical Implant Manual
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2x8 Contact Lead Extension
The 2x8 Contact Lead Extension, also known as the Vercise™ Dual Extension, is a low prole
Extension used with two 8 Contact Leads simultaneously. Each of these Lead Extensions can
connect up to two Leads. The proximal end of the Lead Extension is bifurcated into two tails, each
with 8 Contacts, which are inserted into the IPG. This model is intended to support IPGs implanted
in the pectoral or abdominal region.
Table 19: Technical Specications
2x8 Contact Lead Extension (DB‑3128)
Feature Specication
Overall Length 55 cm or 95 cm
Lead Extension Body Diameter 1.31 mm
Number of Contacts 2x8 (16 total contacts)
Contact Material Platinum/Iridium
Insulation Material Polyurethane, Silicone
Connector Block Material Stainless Steel and Gold
Marker Band Material2Gold
Setscrew Material Titanium
2 The gold marker band indicates the Extension tail that contains Contacts 1 through 8. These same
Contacts 1 through 8 are within the Extension port with the gold connector block.
Distal End
Proximal End

Product Descriptions
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Surgical Tools and Accessories
Lead Boot
The Lead Boot protects the proximal end of the implanted Lead until the IPG implant surgery. The
Setscrew on the Lead Boot is used to secure the Lead in the Lead Boot when screwed onto the
retention sleeve.
The Lead Boot provided in either of the kit types listed below is compatible with 8 Contact Leads:
• An 8 Contact Lead Kit
• Vercise Physician’s Spares Kit
Table 20: Technical Specications
Lead Boot
Feature Specication
Overall Length 3.3 cm
Setscrew Material Titanium
Connector Block Material Stainless Steel
Endstop Material Stainless Steel
Insulation Material Silicone

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Surgical Implant Manual
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Tunneling Tool
The Tunneling Tool is used to create a path for the Lead and Lead Extension in the subcutaneous
tissue.
Table 21: Technical Specications
Tunneling Tool (SC‑4252, DB‑4252, SC‑4254, and DB‑4254)
Feature Specication
Length 28 cm (Straw),
35 cm (Long)
Shaft Material Stainless Steel
Straw Material PTFE
Handle Material Stainless Steel, Ultem
Suture Sleeves
The Suture Sleeve may be used to anchor the Lead or Lead Extension to the fascia. If a mini-plate
is used, the Suture Sleeve is placed between the Lead and the mini-plate to protect the Lead.
Table 22: Technical Specications
DBS Suture Sleeves
Feature Specication
Overall Length 1 cm, 2.3 cm, 4 cm
Material Silicone

Product Descriptions
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SureTek Burr Hole Cover
The SureTek Burr Hole Cover is a Lead-anchoring device for use with the Boston Scientic DBS
System. The Burr Hole Cover is compatible with a burr hole created by a 14 mm perforator. The
components of the Burr Hole Cover are listed in Table 23. The materials for the Burr Hole cover are
listed in Table 24.
Table 23: Components of the SureTek Burr Hole Cover
13
2
4
56
9
7
8
11
10
13
14
15
12
Label Description
1Base
2Buttery Holding Tool
3 Bone Screw
4Lead Exit Slot
5Cap Slot
6 Cap
7Placement/Removal Tool
8Horseshoe End
9Tip End
10 Post
11 Tab
12 Retaining Clip
13 Clip Release Hole
14 Closure Dimple on Slider
15 Screwdriver

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Surgical Implant Manual
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Table 24: Burr Hole Cover Materials (DB‑4600‑C)
Feature Specication
Base Polyether ether ketone (PEEK)
Retaining Clip PEEK
Cap PEEK
Bone Screws Titanium
Buttery Holding Tool Polyetherimide, Silicone
Placement/Removal Tool Polyetherimide, Titanium
Disposable Screwdriver Polybutylene terephthalate (PBT)
polycarbonate resin, stainless steel