Post-Surgery Treatment; Post-Surgery Lead Removal; Label Symbols - Axonics 1201 Mode D'emploi

5. Schedule the patient's follow-up visits at regular intervals to ensure that the stimulation is programmed
optimally.

Post-surgery treatment

Administer prophylactic antibiotics for 24 hours.

Post-surgery lead removal

At the end of the useful life of the product, all implanted components should be removed. If the tined lead needs to be
removed, make a small incision at the lead insertion site. Use sharp and blunt dissection to access and release lead tines
from surrounding tissue. Gentle traction can be used in conjunction with dissection to remove the lead.
Caution: Do not use excessive force to remove the tined lead. A force larger than gentle traction may cause lead
breakage, which can result in device fragments left in the patient's body.
If resistance occurs during lead removal, additional dissection may be needed to release the lead tines and remove the
entire lead.

LABEL SYMBOLS

This section explains the symbols found on the product and packaging.
Symbol
Manufacturer
Product Model Number
Manufacturing Date
Conformité Européenne (European
Conformity): 2016. This symbol
means that the device fully complies
with AIMD Directive 90/385/EEC
(Notified Body reviewed) and
R&TTE Directive 1999/5/EC (self-
declaration)
Refer to instructions for use (Consult
accompanying documents)
Temperature limitation
Humidity limitation
Pressure limitation
Lot number
Description
Curved Stylet
Directional Guide
Straight Stylet
Symbol
Sterilized using Ethylene oxide
Use by
Do not use if package is damaged
For USA audiences only
!USA Rx ONLY
Caution: U.S. Federal law restricts
this device for sale by or on the
order of a physician
Authorized representative in the
European community
Open here
Warning / Caution
Product Literature
Do not reuse
Do not resterilize
Magnetic Resonance (MR)
Conditional
21
Description
Foramen Needle
Introducer Sheath and Dilator