Rivacor 5 VR-T DX - Defibrillator, implantable, automatic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Biotronik Australia Pty Ltd

Class:

AIMD

Manufactured by:

Biotronik SE & Co KG Woermannkehre 1, Berlin, D-12359 Germany

Therapeutic area:

35852 - Defibrillator, implantable, automatic

Therapeutic indications:

A single chamber, rate adaptive ICD with Home Monitoring functions, max. shock energy 40J and DF4/IS-1 connector. Biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. Ellipsoid shape facilitates implantation in the pectoral muscle area. The connections for bipolar pacing, sensing and shock delivery are in the header. DX functionality also senses in the right atrium. MR conditional. Rivacor 5 VR-T DX belongs to a family of implantable cardioverter-defibrillators (ICD). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias with ventricular pacing. The implantation of an ICD is a symptomatic therapy with the following objectives: ?Termination of spontaneous ventricular fibrillation (VF) through shock delivery ?Termination of spontaneous ventricular tachycardia (VT) through antitachycardia pacing (ATP); in case of ineffe

Authorization status:

A

Authorization date:

2019-03-18

Summary of Product characteristics

Rivacor 3/5/7
ICD Family
VR-T, VR-T DX, DR-T,
HF‑T, HF‑T QP
Technical Manual
439132
Revision: D (2019-02-15)
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin / Germany
Tel [phone]
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www.biotronik.com
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All rights reserved.
Specifications subject to modification, revision and
improvement.
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registered trademarks held by BIOTRONIK or the
respective owner.
0123
2018
Table of Contents
1
Table of Contents
1
Product
Description.........................................................................................................
2
Intended Medical Use
.............................................................................................................................
2
System Overview
.....................................................................................................................................
4
Therapeutic and Diagnostic Functions
................................................................................................
10
2
General Safety
Instructions...........................................................................................
13
General Information on Safe Handling of the
Device..........................................................................
13
Operating Conditions
............................................................................................................................
15
Possible Complications
........................................................................................................................
16
Possible
Risks.......................................................................................................................................
18
3
Implantation
..................................................................................................................
20
Implantation
Procedure.............................................................................................