Lead and Extension Insertion Tool Model 1803

Clinician's Manual

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

For U.S. – California Only: Proposition 65, a State of California voter initiative, requires the following notice:

WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

Pat. http://patents.sjm.com

© 2017 St. Jude Medical, Inc. All Rights Reserved.

Prescription and Safety Information Read this section to gather important prescription and safety information.

Intended Use The St. Jude Medical™ lead and extension insertion tool is a hand-manipulated device that is intended for a single use to help insert the terminal end of a neurostimulation lead, extension, or adapter into the header of an implantable pulse generator (IPG) during implantation of a neurostimulation system.

Additional Prescription Information Refer to the clinician's manual for the appropriate neurostimulation system to get additional prescription information, including indications for use and contraindications. For specific instructions, warnings, precautions, and adverse effects about other system components, see the clinician's manual for those components.

Precautions The following precautions apply to these components.

Single use only. Sterilized devices are intended for single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in the sterile packaging to permit direct introduction into the operative field. Do not resterilize or reuse them because of the risk of infection.

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Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.

Package or component damage. Do not use a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to St. Jude Medical for evaluation.

Compatibility Guidelines The St. Jude Medical™ lead and extension insertion tool is compatible with the following devices for spinal cord stimulation (SCS) and deep brain stimulation (DBS).

Table 1. Device compatibility

Component Device Model Number SCS DBS

IPGs Proclaim™ 5 IPG 3665 X

Proclaim™ 5 Elite IPG 3660 X

Proclaim™ 7 IPG 3667 X

Proclaim™ 7 Elite IPG 3662 X

Prodigy™ IPG 3799 X

Prodigy MRI™ IPG 3772 X

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Table 1. Device compatibility

Component Device Model Number SCS DBS

Protégé™ IPG 3789 X

Protégé MRI™ IPG 3771 X

Eon™ IPG 3716 X

Eon Mini™ IPG 3788 X

EonC™ IPG 3688 X

Genesis™ IPG 3608 X

St. Jude Medical Infinity™ 5 IPG

6660, 6661 X

St. Jude Medical Infinity™ 7 IPG

6662, 6663 X

Brio™ IPG 6789 X

Leads 3100-series percutaneous leads 31XX X

3200-series paddle leads 32XX X

Extensions 3300-series extensions 3341, 3343, 3346, 3383, 3386 X

6300-series extensions 6345, 6346 X

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Table 1. Device compatibility

Component Device Model Number SCS DBS

Extensions for the St. Jude Medical Infinity™ DBS System

6339, 6340, 6343, 6344, 6355, 6356, 6359, 6361, 6362, 6363, 6371, 6372, 6373, 6377, 6378, 6379

X

Adapters 8-channel adapter, M 2311, 2316 X X

8-channel adapter, B 2321, 2326 X

The lead and extension insertion tool is compatible with Medtronic™ extension models available before May 5, 2015. (Medtronic is a trademark of Medtronic, Inc.)

Table 2. Device compatibility (Medtronic)

Device Model Number

DBS extension* 37085-40, 37085-60, 37085-95, 37086-40, 37086-60, 37086-95

* The specified DBS extensions are connected to Medtronic DBS leads (Model 3387 or 3389).

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Product Description The St. Jude Medical™ lead and extension insertion tool is a nonpowered, hand-held, surgical accessory that is intended to help insert a neurostimulation lead, extension, or adapter into an IPG header. The insertion tool has five main areas: gripping surface, tip, tab, wing, and lead or extension channel. The following figure shows the features of the lead and extension insertion tool.

Figure 1. Lead and extension insertion tool features

1. Gripping surface 2. Tip 3. Tab 4. Wing 5. Lead or extension channel

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Package Contents The lead and extension insertion tool kit (Model 1803) contains five individually packaged, sterile lead and extension insertion tools.

Directions for Use After the lead or extension is implanted at the desired location and has been tunneled to the IPG pocket, use the lead and extension insertion tool to insert the terminal end of the lead or extension into the IPG header. To use the lead and extension insertion tool, follow these steps:

NOTE: For information on lead and extension placement, see the directions for use in the clinician's manual for the appropriate lead or extension kit.

1. Before using the insertion tool, manually insert the lead or extension into the IPG header and slide the lead or extension until it becomes difficult to advance further into the header.

2. Holding the insertion tool between your forefinger and thumb, place the tool around the terminal end of the lead or extension such that the tip is 2 to 3 mm from the last visible contact band.

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Figure 2. Insertion tool placed around the terminal end of the lead or extension

1. Insertion tool 2. Last visible contact band on the

terminal end of the lead or extension

NOTE: To prevent damage to the lead or extension, ensure the gripping surface of the tool does not cover the electrode or the contact band.

3. Using your forefinger and thumb, pinch the gripping surface of the insertion tool until the tool closes around the lead or extension body. When the lead or extension is properly seated within the channel of the tool, both wings of the tool are flush together.

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Figure 3. Correct versus incorrect insertion of tool into the header port

1. (Correct) Tip of tool is closed and perpendicular to the header

2. (Incorrect) Tip of tool is open and bent

NOTE: To prevent damage to the insertion tool when inserting it into the header of the IPG, ensure the tip of the tool remains closed and in full contact with the lead or extension body.

NOTE: The insertion tool is designed for a portion of the tip of the tool to enter the header port of the IPG during insertion of the lead or extension.

4. While applying pressure to the gripping surface of the insertion tool, advance the terminal end of the lead or extension and push the tip of the tool into the appropriate header port until the terminal end is fully inserted into the header, as described in the clinician's manual for the appropriate IPG.

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Figure 4. Tip of tool inserted into the header port

5. While the tool and the lead or extension are fully inserted into the IPG header, use the torque wrench provided in the IPG kit to tighten the setcrew.

6. Release the gripping surface by regrasping the tool with your forefinger at the edge of the wings and your thumb at the tab.

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Figure 5. Regrasping the tool to release the gripping surface

7. Pull back on the tool to remove it from the IPG header port. The terminal end of the lead or extension remains fully inserted in the header port.

8. Repeat the steps in this section for additional leads or extensions.

9. Follow the instructions for inserting port plugs into any unused ports (if needed) and placing the IPG as described in the clinician's manual for the appropriate IPG.

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Technical Support For technical questions and support for your St. Jude Medical™ neuromodulation product, use the following information: +1 972 309 8000

+1 800 727 7846 (toll-free within North America)

For additional assistance, call your local St. Jude Medical representative.

Appendix A: Product Specifications The lead and extension insertion tool (Model 1803) has the following physical specifications.

Table 3. Lead and extension insertion tool specifications

Length 3.18 cm (1.25 in)

Width 2.29 cm (0.90 in)

Weight 0.62 g (0.02 oz)

Storage temperature -10°C–55°C (14°F–131°F)

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Appendix B: Symbols and Definitions The following symbols may be used in this document and on some of the products and packaging:

Table 4. Symbols and definitions

Symbol Definition

Caution, consult accompanying documents

Consult instructions for use

Follow instructions for use on this website

Single use only

Do not resterilize

Expiration date

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Table 4. Symbols and definitions

Symbol Definition

Date of manufacture

Manufacturing facility

Temperature limits for storage conditions

Humidity limits

Pressure limits

Do not use if the product sterilization barrier or its packaging is compromised

Catalog number

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Table 4. Symbols and definitions

Symbol Definition

Manufacturer

Contents quantity

Accessories

Lot number

Prescription use only

Ethylene oxide gas sterilization

Authorized European representative

European conformity, affixed in accordance with the relevant provisions of AIMD directive 90/385/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive.

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St. Jude Medical 6901 Preston Road Plano, Texas 75024 USA +1 972 309 8000

St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11

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