Attesta S DR MRI SureScan ATDRS1 - Dual-chamber pacemaker, rate-responsive

Intended purpose

The Medtronic Attesta S DR MRI SureScan model ATDRS1 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 This device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include: • Various degrees of AV block to maintain the atrial contribution to cardiac output • VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm • Vasovagal syndromes or hypersensitive carotid sinus syndromes

Functional description

The Medtronic Attesta S DR MRI SureScan Model ATDRS1 dual chamber implantable pulse generator (IPG) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing.