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Abbott Proclaim 3662 User Manual

Abbott Proclaim 3662
80 pages
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Proclaim™ Implantable Pulse Generator
Models 3660, 3661, 3662, 3663, 3665, 3667
Clinician's Manual

Table of Contents

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Abbott Proclaim 3662 Specifications

General IconGeneral
IndicationChronic Pain Management
Stimulation Channels16
Battery TypeRechargeable Lithium-Ion
Battery LifeUp to 10 years
Recharge TimeApproximately 1 hour
CommunicationWireless
Targeted TherapySpinal Cord Stimulation
MRI ConditionalYes, with conditions
ProgrammabilityMultiple programmable settings

Summary

Prescription and Safety Information

MRI Safety and Warnings

Provides guidelines for MRI compatibility and critical safety warnings for system use.

Precautions

Outlines general precautions, clinician/patient responsibilities, and environmental safety.

Adverse Effects and System Overview

Adverse Effects

Lists potential adverse effects associated with the neurostimulation system.

Product Description

Connecting a Lead or Extension to the IPG

Implanting the IPG

IPG Replacement, Disposal, and Battery Status

IPG Specifications

Appendix B: System Components and Accessories

Appendix C: Battery Longevity Information

Appendix D: Regulatory Statements

Appendix E: Safety and Effectiveness Studies

Clinical Summary for Genesis IPG System

Summarizes clinical data on the Genesis IPG system for SCS.

Clinical Summary for BurstDR Stimulation

SUNBURST™™ Study Design

Details the design and methodology of the SUNBURST™ study.

Study Demographics and Pain Characteristics

SUNBURST™™ Study Safety Results

Programming and Recharging Data

SUNBURST™™ Study Results

Primary Effectiveness

Reports on the primary effectiveness endpoint (non-inferiority of burst vs. tonic).

Secondary Effectiveness

Paresthesia Coverage Data

Conclusions Drawn from the Study

Effectiveness Conclusions

Summarizes findings related to the system's effectiveness.

Safety Conclusions

Summarizes the study's safety findings.

Benefit-Risk Conclusions

Assesses the overall benefits versus risks of the device.

Study Limitations

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