Abbott Prodigy 3855 - Instructions to Patients; Safety and Effectiveness Studies; System Overview; Product Description

▪ Are able to operate the device▪
▪
Are suitable candidates for surgery and free of acve general infecons
▪
Instrucons to Paents
The paent should be given simple and praccal instrucons regarding the operaon and care of the
neurosmulaon system. Also, the paent should be given guidelines about how posture and acvity can
aect smulaon as well as under what circumstances the physician should be contacted regarding device
problems.
Safety and Eecveness Studies
For informaon that supports the clinical use of this neurosmulaon system, refer to the clinical summaries
manual for spinal cord smulaon (SCS) systems (available online at
medical.abbo/manuals). This
neurosmulaon 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 eecveness of this
neurosmulaon system.
System Overview
This rechargeable neurosmulaon system is designed to deliver low-intensity electrical pulses to nerve
structures. The neurosmulaon system includes the following main components:
▪
Implantable pulse generator (IPG)
▪
▪ Leads▪
▪
Paent programmer
▪
▪
Rapid Programmer
™ system▪
▪
Charging system
▪
The IPG delivers electrical pulses through the leads to electrodes near selected nerve bers in order to
provide therapeuc smulaon. The
Rapid Programmer
system and the paent programmer allow clinicians
to create and modify programs for a paent. Paents use the programmer to control these prescribed
programs, and they use the charging system to recharge the IPG’s baery.
The following image shows how the major system components are intended to interact.
Figure 1. Interacon between main system components
1. Rapid Programmer system (clinician only)1.
2. Paent programmer2.
3. IPG3.
4. Leads4.
5. Charging system5.
NOTE: This manual provides instrucons for using the paent programmer. For instrucons about
implantable components, such as leads and the IPG, see the applicable clinician's manual for that
component.
Product Descripon
The paent programmer allows clinicians to create and modify programming parameters for the IPG. Powered
by three disposable AAA baeries, the programmer communicates with the IPG using radiofrequency (RF)
5