Azure S SR MRI SureScan W3SR01 - Single-chamber pacemaker, rate-responsive

Intended purpose

The Medtronic Azure S SR MRI SureScan model W3SR01 implantable pulse generator (IPG) is indicated for the following conditions: • Accepted patient conditions warranting chronic cardiac pacing, which include: – Paroxysmal or permanent Type 2 second- or third-degree AV block – Symptomatic Type 1 second-degree AV block or block located at intra- or infra-His levels, regardless of symptoms – Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders – Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias – Alternating bundle branch block – Bundle branch block with unexplained syncope and abnormal EPS or non-diagnostic evaluation • Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity.

Functional description

The Azure S SR MRI SureScan Model W3SR01 single chamber implantable pulse generator (IPG) is a multi-programmable cardiac device that monitors and regulates the patient’s heart rate by providing single chamber rate-responsive bradycardia pacing. This device features Bluetooth wireless technology.