Unify Assura CD3361-40C - Defibrillator, implantable, automatic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Abbott Medical Australia Pty Ltd

Class:

AIMD

Manufactured by:

St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, 91342 United States Of America

Therapeutic area:

35852 - Defibrillator, implantable, automatic

Therapeutic indications:

The Unify Assura CD3361-40C is a cardiac resynchronisation therapy device with RF telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and Single Site Pacing. It features an IS-1/DF-1 device header and Parylene coating. The Unify Assura CD3361-40C is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy devices (CRT-Ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. Also AT/AF detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF.

Authorization status:

A

Authorization date:

2013-03-19

Patient Information leaflet

Merlin@home
TM
Transmitter
Compatible
Unify Assura
™
Cardiac Resynchronisation Therapy Defibrillator (CRT-D)
Cardiac Resynchronisation Therapy (CRT) Devices
Product Highlights
■
■
Parylene coating for improved abrasion resistance
■
■
DynamicTx
™
Over-Current Detection Algorithm automatically changes shock
configurations
to ensure delivery of high voltage therapy when high current is
detected
■
■
Cold Can programmability provides an additional RV-SVC Shock
Configuration to decouple
the can from the shocking vector parameters in cases of lead problems
■
■
ShockGuard
™
technology with DecisionTx
™
programming designed to reduce inappropriate
therapy and minimise the need for programming adjustments at implant
■
■
SecureSense
™
RV lead noise discrimination detects sustained and short bursts of
lead noise that
would otherwise go unnoticed or potentially lead to one or more
inappropriate shocks
■
■
Far Field MD
™
morphology discrimination and Chamber Onset discrimination improve SVT
and
VT discrimination for reduced inappropriate therapies
■
■
Antitachycardia pacing (ATP) while charging and prior to charging in
the VF zone further extends the programming options for
terminating tachyarrhythmias without a high-voltage shock
■
■
Low Frequency Attenuation filter designed to enhance sensing
performance and may reduce the possibility of oversensing T-waves
■
■
Sense_Ability_
™
feature provides flexibility to fine-tune programming around T-wave
oversensing without decreasing sensitivity
■
■
DF4 connector designed to streamline defibrillation connections into a
single terminal pin and reduce the number of set screws
■
■
Unique 40 J delivered energy safety shock option can provide a greater
DFT safety margin
■
■
DeFT Response
™
technology offers the most noninvasive options for managing high DFTs
■
■
QHR
™
* chemistry battery provides greater capacity for enhanced longevity
and improved charge time performance compared to
previous SVO batteries
■
■
Vibra

Summary of Product characteristics

Ellipse™
Tiered-therapy Cardioverter/Defibrillator
Fortify Assura™
Tiered-therapy Cardioverter/Defibrillator
Quadra Assura™, Quadra Assura MP™
Cardiac Resynchronization Device, Tiered-therapy
Cardioverter/Defibrillator
Unify Assura™
Cardiac Resynchronization Device, Tiered-therapy
Cardioverter/Defibrillator
Unless otherwise noted, ™ indicates that the name is a trademark of,
or licensed to, St. Jude Medical or one of its subsidiaries.
ST. JUDE MEDICAL and the nine-squares symbol are trademarks and
service marks of St. Jude Medical, Inc. and its related
companies. © 2015 St. Jude Medical, Inc. All Rights Reserved.
1
Device Description
This manual describes the following St. Jude Medical™
pulse generators
1
:
Table 1. Single-chamber pulse generator descriptions
Name
Model
Number
Description
Connector
Type
Delivered Energy
(approx.)
MRI Status
Fortify Assura VR
CD1257-40
Single-chamber ICD with RF
telemetry
DF-1/IS-1
40 J
Untested
Fortify Assura VR
CD1257-40Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
40 J
Untested
Fortify Assura VR
CD1259-40
Single-chamber ICD with RF
telemetry
DF-1/IS-1
40 J
Untested
Fortify Assura VR
CD1259-40Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
40 J
Untested
Fortify Assura VR
CD1261-40
Single-chamber ICD with RF
telemetry
DF-1/IS-1
40 J
Untested
Fortify Assura VR
CD1261-40Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
40 J
Untested
Ellipse VR
CD1275-36
Single-chamber ICD with RF
telemetry
DF-1/IS-1
36 J
Untested
Ellipse VR
CD1275-36Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
2
36 J
Untested
Ellipse VR
CD1277-36
Single-chamber ICD with RF
telemetry
DF-1/IS-1
36 J
Untested
Ellipse VR
CD1277-36Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
36 J
Untested
Ellipse VR
CD1279-36
Single-chamber ICD with RF
telemetry
DF-1/IS-1
36 J
Untested
Ellipse VR
CD1279-36Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
36 J
Untested
Ellipse VR
CD1311-36Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
36 J
Untested
Ellipse VR
CD1311-36
Single-chamber ICD with RF
telemetry
DF-1/IS-1
36