Lead Implant Procedure; Procedure Supplies; Procedure Preparation - Axonics 1201 Mode D'emploi

• Tines/Anchor
• Retention sleeve
• Conductor wires Insulation
• Jacket tubing
Note: All dimensions are approximate.

LEAD IMPLANT PROCEDURE

The following section describes the procedure for implanting the Axonics tined lead.

Procedure supplies

In addition to the surgical tools required by the physician, the following supplies are needed for the implantation
of the tined lead:
• Axonics Tined Lead Kit (Model 1201)
• Axonics Clinician Programmer (CP) (Model 1501)
• Axonics Lead Implant Kit (Model 1801)
• EMG cables (optional) (Model 9002)
• Medical images from previous test or permanent lead implants to be used to inform correct lead placement (if
applicable).

Procedure preparation

1. Place the patient prone with an approximate 30° flexion at the hip and knees. Place a pillow underneath the
patient abdomen/hips if necessary to flatten the sacrum in the horizontal plane.
2. Prep the patient's lower back out laterally to the hips and extending the prep down to the buttocks, perianal
area and perineum for sterile surgery.
Administer local anesthesia or general anesthesia/sedation, if applicable. Note: Do not use muscle relaxants
3.
or paralytic agents. Use of muscle relaxants or paralytic agents during anesthesia will diminish or eliminate
muscle response to stimulation.
4. Affix the stimulation ground pad (non-sterile) to the skin.
a. Clean and dry skin area where ground pad is to be affixed (trimming hair from area is often helpful).
b. Open the pouch of the ground pad.
c. Peel the plastic packing off the ground pad.
d. Apply ground pad to the skin area. Hold in place for 15 seconds.
e. Insert the black plug into the CP ground ( ) next to Needle Test Stimulation Cable (Figure 6).
5. Affix the EMG Cables to the foot and anus area (Optional).
a. The EMG electrodes (one red cable and one black cable) for the perineal musculature response (the anal
bellows) should be placed over the levator ani muscle (Figure 4).
Figure 4. EMG placement for perineal musculature (bellows) muscle response.
Figure 5: EMG electrode placement for perineal
Polyurethane
MP35N
Fluoropolymer
Polyurethane
PROPOSED AXONICS FIGURE
Ground
musculature recordings (bellows response)
Red
Black
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