Indications For Use; Implantable Pulse Generator - Boston Scientific Precision Manuel Supplémentaire

Indications for Use

The Indications for Use has been modified as follows:
The Precision™ System for Peripheral Nerve Stimulation (PNS) is indicated as an aid in the
management of chronic intractable pain.
NOTE: Precision System for Peripheral Nerve Stimulation replaces all references to Precision
Spinal Cord Stimulator System.
Warnings
Magnetic Resonance Imaging (MRI).
Patients implanted with the Precision SCS system should not be subjected to MRI. MRI exposure
may result in dislodgement of implanted components, heating of the neurostimulator, damage
to the device electronics and/or voltage induction through the leads and Stimulator causing an
uncomfortable or "jolting" sensation.

Implantable Pulse Generator

The "Implantable Pulse Generator" section of the Precision SCS Clinician Manual "Device
and Product Description" section has been modified as follows:
The Precision Implantable Pulse Generator (IPG) system is intended to treat chronic pain by
electrically stimulating the peripheral nerves.
Leads
The "Leads" section in the Precision SCS Clinician Manual "Device and Product
Description" section has been modified as follows:
Percutaneous leads function as a component of the Precision SCS system by delivering
electrical stimulation to peripheral nerves of the trunk, resulting in an inhibition of pain
sensation.
NOTE: Disregard the "Surgical Paddle Lead" section. Paddle leads are not approved for use
with Peripheral Nerve Stimulation.
Percutaneous Lead Placement for Peripheral Nerve Stimulation
(PNS)
This section replaces the "Percutaneous Lead Placement in the Epidural Space" section of
the Precision SCS Clinician Manual when placing leads for Peripheral Nerve Stimulation.
Do not use the lead's pre-loaded stylet as it is curved. It is not used during the "Percutaneous
Lead Placement for Peripheral Nerve Stimulation (PNS)" procedure and can be discarded.
Please replace with the straight lead stylet prior to beginning the procedure.
Precision™ System for Peripheral Nerve Stimulation
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