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Abbott Proclaim 3661 User Manual

Abbott Proclaim 3661
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 3661 Specifications

General IconGeneral
IndicationChronic pain management
TherapySpinal Cord Stimulation (SCS)
MRI ConditionalYes
Stimulation Channels16
Device TypePulse Generator
Battery TypeRechargeable
ProgrammingWireless
Battery LifeUp to 10 years
CommunicationBluetooth

Summary

Prescription and Safety Information

MRI Safety Information

Critical safety guidelines for patients undergoing MRI scans with the device.

Warnings

Essential safety alerts and contraindications for device use.

Precautions

Recommended practices to ensure patient safety and device integrity.

System Overview

Adverse Effects

Potential risks and adverse events associated with the neurostimulation system.

Directions for Use

Creating an IPG Pocket

Surgical steps for preparing the implant site for the IPG.

Connecting a Lead or Extension to the IPG

Instructions for securely connecting system leads and extensions to the IPG.

Implanting the IPG

Detailed surgical procedure for implanting the IPG.

Replacing the IPG

Surgical steps and considerations for replacing an existing IPG.

Technical Support

Appendix A: Product Specifications

Appendix C: Battery Longevity Information

Appendix E: Safety and Effectiveness Studies

Clinical Summary for BurstDR Stimulation

SUNBURST Study Safety Results

SUNBURST Study Results

Primary Effectiveness

Main findings regarding the primary endpoint assessing stimulation effectiveness.

Conclusions Drawn from the Study

Effectiveness Conclusions

Summary of the study's findings on the effectiveness of burst stimulation.

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