Azure� and Astra� pacemakers, and Percepta�, Serena� and Solara� CRT-P
Original Date of Communication: April 2023

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Overview

This Product Education Brief describes a lead impedance alert behavior in Medtronic Azure™, Astra™, Percepta™, Serena™, and Solara™ devices that may be observed when the pacing lead impedance displayed is slightly above the programmed lower alert threshold.

Details regarding CareAlerts and impedance measurements

In Azure, Astra, Percepta, Serena, and Solara devices, a CareAlert may be triggered when the lead impedance displayed is slightly above the programmed lower alert threshold.

See Figure 1 and 2 for an example case where the lower threshold for a lead impedance alert is programmed at 200 ohms. In the Lead Impedance Trend (Figure 1) the precise measured impedance value is 209 ohms; and yet in the CareAlert display (Figure 2) an alert was triggered indicating the impedance crossed the 200 ohm impedance threshold, and suggesting the impedance is 190 ohms. This scenario can happen due to the range of impedance values used for alert monitoring. In this scenario, the devices are functioning within design specifications and tolerances.

Figure 1– Lead Impedance Trend showing precise impedance values over time

Figure 2– CareAlert triggered showing 190 ohms impedance value with a 200ohm alert threshold

While most leads are programmed to pace bipolar, every night the device will assess all lead impedance vectors. Unipolar measurements tend to be lower than bipolar measurements in the same system. Therefore, the nightly unipolar lead impedance measurement will likely be closer to the programmed lower alert threshold than the bipolar measurement.

The impedance value range for alerts is never higher than the measured impedance, so all impedance values that are below the programmed threshold will generate an alert as programmed.

Patient Management

Clinicians should continue to follow patients per their standard clinical practice when a CareAlert triggers for lead impedances. Impedance alerts are designed to prompt the clinician to review impedances in the Lead Impedance Trend Log. The Lead Impedance Trend records precise lead impedance measurements over time. These historic impedance measurements provide evidence as to whether the impedance is stable and functioning as designed (albeit near the programmed threshold); or unstable and necessitating further assessment and/or close monitoring.

Note: If impedance values reported in the Lead Impedance Trend indicate impedances are below the programmed lower threshold, then the lead should be assessed for possible insulation breach per standard clinical practice.