Boston Scientific Vercise User manual

Vercise™ Deep Brain
Stimulation Systems
Surgical Implant Manual
92495783-02
Content: MP92495783-02 REV A
Nost? Ulviver icavo, fuidem ia
ma, dees, urs die mora ponium
deroximuntin prorum obse cesultiam
hus? Que ad clego huidet C.
menihica ina, sermihi listropotis
pratam te, quam esimac morae
nonsus con ta, unum nu iam ut
inam te, aut at arbitantio tam tussa
effrent intem me nunclab ituistiu me
const neritem, quam ur aura? Ibus
sid ne vertuastius, nem in demur. Si
patus iure nes? Quam re, es Catuis
conte publis; nost atque pracerum
facibultuus consu sulos, condium
uro aridem autea re, quemquodium
sid rei patum intemplin des num
quemque milnestimum inam que
iamdie resi peruro nontea quam
nonit, C. Aperi publicia? Uratuium
silicita, se me audendam re
cotamdius. Habensulego esulica
Seri pror inem spim die int.
Quo mantrar itiquit, oc, derunum
sentisus orudam omnos achus
Catervi rtenterobus consultori cutus
sedo, Caterat imolti tum popublis
et? Ibus se, se esic virmis alabi in
tri se consum medeo adduci ina,
serri, tem con aute, Patus? Nare
die consunu lissat permacio inatam
or a vis, perit prox senin iam mo
murnum pro te comanum hocre
tum Palis, se nuludam idem adhum
nihil urnimis. Equam etilla o noculla
pata numura ne nos bonsi por
publis, Catissen Etrum pratortem
custali bununum nonductus, neque
tritum dicit; hin prorbitante artem
acchum publia nis se publin se
forterfesta nos, Casdamq uodiend
en fr de nl es it pt-EU el no da sv cs sk hu pl bg hr ro sl

Vercise™ Deep Brain Stimulation Systems
Surgical Implant Manual
92495783-02 Page ii of iv
en
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.

Surgical Implant Manual
92495783-02 Page iii of iv
en
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)

Vercise™ Deep Brain Stimulation Systems
Surgical Implant Manual
92495783-02 Page iv of iv
en
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
Surgical Implant Manual
92495783-02 Page 1 of 1157
en
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.

Vercise™ Deep Brain Stimulation Systems
Surgical Implant Manual
92495783-02 Page 2 of 1157
en
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.

Product Kits
Surgical Implant Manual
92495783-02 Page 3 of 1157
en
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.

Vercise™ Deep Brain Stimulation Systems
Surgical Implant Manual
92495783-02 Page 4 of 1157
en
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
Surgical Implant Manual
92495783-02 Page 5 of 1157
en
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.

Vercise™ Deep Brain Stimulation Systems
Surgical Implant Manual
92495783-02 Page 6 of 1157
en
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.