Instructions To Patients; Safety And Effectiveness Studies; System Overview; Product Description - Abbott Prodigy 3855 System Manual

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Are able to operate the device
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Are suitable candidates for surgery and free of active general infections

Instructions to Patients

The patient should be given simple and practical instructions regarding the operation and care of the
neurostimulation system. Also, the patient should be given guidelines about how posture and activity can
affect stimulation as well as under what circumstances the physician should be contacted regarding device
problems.

Safety and Effectiveness Studies

For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries
manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). This
neurostimulation system is similar in technology and intended use to the systems reported in the literature
and clinical studies. Therefore, the literature and clinical studies represent the safety and effectiveness of this
neurostimulation system.

System Overview

This rechargeable neurostimulation system is designed to deliver low-intensity electrical pulses to nerve
structures. The neurostimulation system includes the following main components:
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Implantable pulse generator (IPG)
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Leads
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Patient programmer
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Rapid Programmer™ system
▪ ▪ Charging system
The IPG delivers electrical pulses through the leads to electrodes near selected nerve fibers in order to
provide therapeutic stimulation. The Rapid Programmer system and the patient programmer allow clinicians
to create and modify programs for a patient. Patients use the programmer to control these prescribed
programs, and they use the charging system to recharge the IPG's battery.
The following image shows how the major system components are intended to interact.
Figure 1. Interaction between main system components
NOTE: This manual provides instructions for using the patient programmer. For instructions about
implantable components, such as leads and the IPG, see the applicable clinician's manual for that
component.

Product Description

The patient programmer allows clinicians to create and modify programming parameters for the IPG. Powered
by three disposable AAA batteries, the programmer communicates with the IPG using radiofrequency (RF)
1. 1. Rapid Programmer system (clinician only)
2. 2. Patient programmer
3. 3. IPG
4. 4. Leads
5. 5. Charging system
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