Accolade

Indicated for patients with symptomatic congestive heart failure, including left ventricular dysfunction and a wide range of QRS, as well as one or more of the following conditions: - paroxysmal or permanent symptomatic second and third degree AV block. -blocking of bilateral symptomatic branch. - dysfunction of the paroxysmal or transient sinus-synomatic node with or without associated AV conduction disorder (eg sinus bradycardia, sinus arrest, neuroauricular block (SA) - bradycardia - tachycardia syndrome, to prevent symptomatic bradycardia or certain forms of symptomatic tachyarrhythmias.

Model: 60212530, Affected: Lot - 40264005

Model: , Affected: Models L310, L311, L331

aimd

serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.

Cardiovascular Devices

3

Yes

Distributed to the states of TX, NH, MA, PA, and MN.

Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. || These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.