TriageHF, Data Calculation Module (DCM) Model 5242 - Implantable cardiac device management application software

Intended purpose

The TriageHF feature is intended to provide clinicians with an additional and optional source of information for managing their Medtronic cardiac device patients who may be at risk for a heart failure event. TriageHF uses data from compatible cardiac device sensors that measure physiologic parameters to calculate the probability of a heart failure event in the next 30 days.

Functional description

The Device is an algorithm that runs on the Medtronic CareLink Network and uses existing device diagnostic data to produce a dynamically-updated individual patient risk (Low, Medium, or High) of having a heart failure (HF) hospitalization in the next 30 days. CareLink displays the HFRS on the CareLink network for compatible Medtronic cardiac devices. The TriageHF feature integrates the diagnostic data collected by the implanted device and provides an overall heart failure risk assessment.