• The device should not be autoclaved or exposed to ultrasonic cleaners to allow it to be analyzed by Axonics.
• Any components not returned to Axonics should be disposed of according to local regulations. Any potentially
contaminated materials should be treated as biohazardous waste.
Note that in some countries, explanting a battery-operated implantable device is mandatory.
Cautions:
• Components that are explanted or that have come into contact with bodily fluids should be handled with
appropriate biohazard controls. Such components should only be returned to Axonics in packaging supplied by
Axonics.
• The TS may explode if subjected to high temperatures. Therefore the TS should not be incinerated and should be
explanted before patient cremation.
• Implantable devices should not be reused after exposure to body tissues or fluids. The sterility and functionality
of these devices cannot be assured.
DEVICE DESCRIPTION
The Axonics PNE lead (Figure 1) has one cylindrical electrode area. This area is designed to be implanted adjacent to
one of the sacral nerve roots (most often the third sacral nerve root).
There are also short sections of the lead that serve as markers. These markers indicate lead depth relative to the short
and long foramen needles. The proximal end of the lead has a pin for insertion of the lead into the Basic Trial Cable.
Package contents
The PNE Lead Kit (Axonics Model 1701) contains the following:
• PNE lead
• Stylet (in situ)
• Needle test stimulation cable
• Short Foramen needle (x2)
• Long Foramen needle (x2)
• PNE Ground Pad and Cable
• Needle Stimulation Pad and Cable
• Basic Trial Cable
• PNE Lead Implant Manual (this document)
• PNE Lead Implant Accessories:
– Sponge Swab Applicator Sticks
– Ruler 6"
– Sterile Surgical Marker
– Surgical Utility Drape with Tape 15.5" x 25"
– Gauze Pads 2" x 2"
– Gauze Pads 3" x 3"
– Gauze Pads 4" x 4"
– Tegaderm 2 3/8" x 2 ¾"
– Tegaderm 4" x 4 ¾"
– Syringe 10mL
Figure 1 . Axonics PNE Lead
10