Device Description; Package Contents - Axonics 1201 Mode D'emploi

DEVICE DESCRIPTION

The Axonics tined lead (Figure 1) has four cylindrical electrodes designed to be implanted adjacent to one of the sacral
nerve roots (most often the third sacral nerve root). All four electrodes are equal in length and spaced equidistantly
along the lead.
The distal end of the lead has tines to anchor the lead in the sacrum and surrounding connective tissue. There are also
markers to indicate lead depth and level of tine deployment during implantation. The proximal end of the lead has a
marker to facilitate complete insertion of the lead into the Neurostimulator header. Markers B, C, and D can only be seen
visually, while marker A can also be seen under fluoroscopy.

Package contents

The Tined Lead Kit (Axonics Model 1201) contains the following:
• Tined lead
• Straight stylet (in situ)
• Curved stylet
• Tined lead test stimulation cable
The contents of the inner packages are STERILE. The contents of the Tined Lead Kit are intended for single use only.
The Tined Lead Implant Kit (Axonics Model 1801) contains implant tools (Figure 2) and cables (Figure 3):
Package contents:
• Foramen needle (x2)
• Directional guide
• Introducer sheath and dilator
• Tunneling tool (including a tip and 2 sheaths)
• Torque wrench
• Needle test stimulation cable
The contents of the inner packages are STERILE. The Stimulation ground cable and pad are provided separately and
are not sterile. The contents of the Tined Lead Implant Kit are intended for single use only.
PROPOSED AXONICS FIGURE
Marker
A
Lead
Electrodes
Tines
Distal End
Stylet
End Stop
21 mm
Figure 1. Axonics Tined Lead.
Figure 1: Axonics Tined Lead
Marker
Marker
B
D
Lead
Marker
Contacts
C
Retention
Sleeve
Proximal End
21 mm
9 mm
11