Tined Lead Tunneling; Connecting To A Stimulator; Completing A Lead Implant Procedure - Axonics 1201 Mode D'emploi

• Hold sheath and lead together when adjusting lead position.
Caution: Optimal motor responses should be observed intraoperatively at ≤ 3 mA during test stimulation of the
lead. If the amplitude required to obtain a motor response is larger than 3.0 mA, the lead may not allow for optimal
long-term therapy. Consider repositioning the lead to achieve the desired range.
12. When the tined lead is in its final location, remove the tined lead stimulation cable then carefully withdraw
the introducer sheath and lead stylet under fluoroscopic guidance while holding the tined lead in place
(Figure 18).
Note: Withdrawing the introducer sheath deploys the tines, anchoring the tined lead in place.
Caution:
• Be careful to not displace the tined lead when removing the sheath and stylet.
• Do not deploy the tines until the tined lead is in the correct position.
Figure 18. Grasp the tined lead to hold it in place. Withdraw the introducer sheath
13. Reconnect the tined lead test stimulation cable to the lead and test stimulation with each electrode to confirm
the previous responses.
Notes:
• To advance the lead after the tines are deployed, reinsert the lead stylet and gently adjust the lead position.
• To retract the lead after the tines are deployed, remove the lead completely using gentle traction and replace
the lead.

Tined lead tunneling

For instructions on creating a Neurostimulator pocket, refer to the Neurostimulator Implant Manual.
1. Screw the tunneling tip to the tunneling tool and remove the tunneling tip protector. Make sure the clear
tunneling sheath is in place over the tunneling tool when performing the tunneling part of the procedure.
2. If necessary, bend the tunneling tool to conform to the patient's body.
3. Create a subcutaneous tunnel from the lead to the Neurostimulator pocket.
Note: Deep tunneling is not desirable.
4. Leaving the tunneling sheath in the tunnel, remove the tunneling tool.
5. Gently insert the lead through the sheath.
6. Leaving the lead in position, gently remove the sheath from the tunnel.
7. Close the lead implant incision and dress the wound appropriately.

Connecting to a stimulator

The lead will be connected to the Axonics Model 1101 Neurostimulator. Refer to the Neurostimulator manual for
instructions on connecting the lead.

Completing a lead implant procedure

1. Close and dress all incisions.
2. Give the patient the Remote Control and patient ID card prior to discharge.
Caution:The patient must carry the Remote Control at all times to be able to adjust or turn off the Neurostimulator.
3. Complete the patient and system registration paperwork and return to Axonics.
4. Train the patient on the use of the Remote Control and Charger.
PROPOSED AXONICS FIGURE
and lead stylet. Tines are deployed as the sheath is removed.
Figure 18: Remove the introducer sheath
and lead stylet
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