Azure XT SR MRI SureScan W2SR01 - Single-chamber pacemaker, rate-responsive

Intended purpose

The Medtronic Azure XT SR MRI SureScan model W2SR01 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 XT SR MRI SureScan Model W2SR01 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.