Viewing and Managing Device Advisories in Rhythm360

*Please note the screenshots and information in this article contain fake PHI*

Overview

Rhythm360 identifies and tracks device advisories—also known as device recalls—for all CIED patients. Recalls may apply to a patient’s pulse generator, lead, or other implanted device component.

Patients with a new device or lead advisory are indicated through a patient tag, which can be filtered for on the Patient List.

Viewing Advisories for a Patient

To view a patient's device/lead advisories:

• Open the patient’s profile.
• Look at the patient's devices or leads. Under the device with an advisory, the patient will have a yellow advisory tag.
• Click the Device Advisory tag to open the Device Advisory window.
  • If you are viewing a lead, click the Lead Advisory tag.

The Device Advisories window allows you to:

• View whether each recall is active or resolved
• Acknowledge recalls and document follow-up actions
• Open the official FDA recall page for more details

Acknowledging an Advisory

To remove the New Device/Lead Advisory tag from a patient, the active advisory must be resolved. To do so:

• Navigate to the Device/Lead Advisories window
• Under an active advisory, click Acknowledge.
• Optionally, you can add a note describing what steps you took to resolve the advisory for the patient.
• When finished, click Save.
• The device advisory will become acknowledged. You can now view the timestamp for reference.