Medtronic 97792 Instructions for Use

Injex™ Bi-Wing Anchor

Accessory Kit

97792

Instructions for use

  Rx only

Medtronic® is a trademark of Medtronic, Inc., registered in the U.S. and other
countries.

Injex™ is a trademark of Medtronic, Inc.

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Table of contents

Description 7

Package contents 7

Material of components 7

Instructions for use 7

Anchoring the lead and creating strain relief loops 7
Removing an anchor from the lead 10

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 indications, safety, contraindications, warnings,
precautions, and adverse events.

The indications sheet provides information about indications and
related information.

The system eligibility, battery longevity, specifications manual
provides information about neurostimulator selection, battery
longevity calculations, and battery characteristics.

MRI guidelines provide information about any MRI conditions and MRI­specific 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.

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Description

The Injex Model 97792 Bi-Wing Anchor Accessory Kit is designed only for
use with Medtronic percutaneous in-line connector neurostimulation leads for
spinal cord stimulation (SCS). The tools in this accessory kit are designed
solely for the placement and removal of the Injex anchors.

Package contents

Anchor with anchor dispenser tool (2)

▪

Anchor removal tool

▪

Product literature

▪

Material of components

Table 1. Material of components in the anchor accessory kit package

Component Materials

Materials and
substances to
which the
patient can be
exposed

Anchor dispenser tool Polycarbonate,

Anchor Silicone rubber

Anchor removal tool Polypropylene,

polytetrafluoroethylene,
stainless steel

stainless steel

Instructions for use

Notes:

This accessory kit is designed only for use with Medtronic percutaneous

▪

in-line connector neurostimulation leads for spinal cord stimulation
(SCS).

Before opening the package, verify the model number and use-by date.

▪

Refer to the appropriate lead implant manual for information about lead
placement and implant.

Anchoring the lead and creating strain relief loops

1. Prepare the anchor site by making a 5 to 7 cm (2.0 to 2.8 in)

longitudinal incision around the needle shaft, dissecting down to the
supraspinous ligament, and establishing hemostasis.

2. Disconnect the stylet from the lead. Partially expose but do not
completely withdraw the stylet.

3. While maintaining lead position, use minimal force to remove the needle
and stylet.

Caution: Use minimal traction to remove the needle because
quick or sudden removal may dislodge the lead.

4. Locate the anchor dispenser tool with a preloaded anchor (Figure 1).

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Handle

Slot

Metal shaft

Anchor

Figure 1. Anchor dispenser tool with the anchor.

5. Thread the connector end of the lead into the metal shaft of the anchor
dispenser tool until the lead exits past the handle and through the slot
(Figure 2).

Anchor

Lead

Thread lead through metal shaft

Figure 2. Threading the lead through the metal shaft.

6. With one hand, grasp a portion of the lead that exited the slot, and with
the other hand, gently advance the anchor dispenser tool until the
anchor is at the anchoring site. Use care to maintain lead position.

Cautions:

The anchoring site should be as close as possible to where the

▪

lead emerges from the fascia. Anchors not secured to the
ligament or fascia in the anchor site may result in lead
migration.

Do not use medical adhesives with the anchors in this kit.

▪

Medical adhesives may not provide sufficient anchoring
strength, resulting in lead migration.

Notes:

If desired, embed the distal tip of the anchor into the anchor site

▪

tissue.
Lubricants (eg, sterile water) are not required for anchor placement

▪

using the anchor dispenser tool.

7. Use fluoroscopy to verify lead location.

Handle

Base

Slot

Lead

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8. While maintaining lead position with one hand, position the fingers and

thumb of the other hand on the anchor dispenser tool similar to holding
a syringe (Figure 3).

To release the anchor, use the fingers to pull the handle of the anchor
dispenser tool towards the thumb. The anchor will slide off the metal
shaft onto the lead.

Note: If the lead or anchor is not dry—after releasing the anchor,
maintain lead position for at least 15 seconds to allow for anchor
compression and adequate retention on the lead.

Figure 3. Releasing the anchor.

9. Grasp the lead near the anchor and use your other hand to gently slide

the anchor dispenser tool off from the end of the lead.
Note: If the anchor needs to be removed, use the anchor removal tool.

Refer to "Removing an anchor from the lead" on page 10.

10. Use 2-0 nonabsorbable suture material (such as silk or some types of
braided polyester mesh) to thread through the suture holes to tie down
the anchor.

a. Pull the sutures to draw the anchor towards the ligament or fascia.
b. Tie the sutures securely.

Cautions:

Do not use polypropylene suture material on silicone

▪

components. Polypropylene may damage the component,
resulting in component failure.

Do not overtighten ligatures on the anchor or connector boot.

▪

Ligatures that are too tight may damage the component.
Do not tie ligatures around the lead or extension body, which

▪

may damage the insulation.

11. While maintaining lead position, create a strain-relief loop with the lead
body near the secured anchor (Figure 4).

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Lead electrodes

Neurostimulator

Anchor

Figure 4. Strain-relief loop made with the lead body.

Cautions:

Do not pull the lead or extension taut. Allow enough slack in

▪

the lead or extension to accommodate patient movement.
Pulling the lead or extension taut may result in a short or open
circuit or migration of implanted components.

Coil the excess lead body into a circular loop greater than

▪

2 cm (0.8 in) in diameter. Do not use a U-shaped loop or bend
(Figure 5). A circular loop decreases the possibility of
electromagnetic interference and its effects and prevents
kinking or damaging the lead body.

Figure 5. Coiling excess lead.

12. Ensure that the lead has not moved during the anchoring process. If the
lead has moved, reestablish paresthesia coverage using program
settings or minor lead repositioning as required.

Notes:

For lead repositioning, refer to the appropriate product labeling.

▪

Continue the procedure as described in the appropriate product

▪

manual.

Strain-relief
loop

≥ 2 cm

Removing an anchor from the lead

If an anchor must be removed from the lead, proceed as follows:

1. Cut any suture material that is securing the anchor.

2. If necessary, expose the embedded anchor tip.

3. Locate the anchor removal tool (Figure 6).

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Slitting blade

Lead electrodes

Handle

Wide end of track

Side view End view

Figure 6. Anchor removal tool.

4. Position the anchor removal tool near the anchor with the slitting blade

facing in the direction of the lead electrodes and the bottom of the track
aligned with the lead body.

5. Starting at the wide end of the track (opposite the slitting blade), slide a

finger along the underneath side of the lead to press the lead into the
track (Figure 7).

Anchor removal tool

Lead electrodes

Anchor

Figure 7. Anchor removal tool placement on the lead.

6. While holding the lead with one hand, use the other hand to push the

anchor removal tool about one-half to two-thirds of the way through the
anchor. Take care not to disrupt lead placement.

Keep the top of the anchor removal tool handle parallel with the

▪

anchor axis when slitting the anchor wall.

Caution: Do not hold the anchor removal tool at a sharp angle
and then use excessive force to push the tool through the anchor.
Using a sharp angle and excessive force at the same time could
result in dislodgement of the lead and/or damage to the lead or
anchor removal tool. Dislodgement of or damage to the lead may
require additional surgery to restore therapy.

Do not pull back on the lead to create counter tension. Pulling on the

▪

lead may dislodge it.

7. Push the anchor removal tool through the remainder of the anchor,

while using the forceps to grasp a slit segment of the anchor, if needed
(Figure 8).

Place the lead body in the track
starting at the wide end

Opening at bottom

of track

Lead

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Anchor removal tool

Anchor

Lead

Hemostatic forceps

Figure 8. Using a grasping tool during anchor removal.

8. Gently remove the anchor removal tool.

9. Remove any remaining suture material that was securing the anchor.

10. Gently remove the anchor from the lead.

11. Inspect the lead for any damage near the anchor site.

12. Discard the anchor and anchor removal tool after the anchor has been

removed from the lead.

13. Use fluoroscopy to verify lead position.

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Manufacturer

Medtronic, Inc.
710 Medtronic Parkway,
Minneapolis, MN 55432-5604,
USA
www.medtronic.com
Tel. [phone]

REP

Authorized Representative
in the European Community

Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen,
The Netherlands
Tel. [phone]

Europe/Africa/Middle East Headquarters

Medtronic International Trading Sàrl
Route du Molliau 31,
Case Postale 84
CH - 1131 Tolochenaz,
Switzerland
www.medtronic.eu
Tel. [phone]

Asia-Pacific

Medtronic International Ltd.
50 Pasir Panjang Road,
#04-51 Mapletree Business City,
Singapore 117384,
Singapore
Tel. [phone]

EC

*M946390A003*

© Medtronic 2019
All Rights Reserved

2019-10-01
M946390A003 Rev B