Device Dossier

Quadra Allure MP PM3562 - Biventricular pacemaker

Device Dossier for Quadra Allure MP PM3562 - Biventricular pacemaker (Biventricular pacemaker, Class III, sponsor Abbott Medical). ARTG record, intended…

Intended purpose

Quadra Allure MP PM3562 is intended to be implanted when a patient has one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia, or any combination of these symptoms. The implantation of Quadra Allure MP PM3562 is also intended for patients who would benefit from resynchronisation of the right and left ventricles or have one or more conventional indications for the implantation of a pacemaker. Also the Quadra Allure MP PM3562 is indicated for patients who exhibit sick sinus syndrome, chronic symptomatic second-degree and third-degree AV block, recurrent Adam-Stokes syndrome and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.

Functional description

Quadra Allure MP PM3562 is a CRT-P with RF telemetry which monitors and regulates the patient's heart rate through dual chamber bradycardia pacing and improve ventricular resynchronization through biventricular pacing. It is a quadripolar device with MultiPoint Pacing and provides the option to select from 4 left ventricular pacing electrodes and 14 pacing vectors. This device is MR conditional.

TGA Public Summary