BOSTON SCIENTIFIC CORPORATION · Insertable Cardiac Monitor (ICM/ILR) · First cleared Sep 2025
Total Reports
551
Reports (30d)
5
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Premature Battery Depletion Analysis
insertable cardiac, battery, adverse, icm device, effects
6
reports
Device Explanted Due to Infection
explanted, insertable cardiac, adverse, icm device, effects
2
reports
False Pause Episode Due to Undersensing
noise, episodes, false, tachycardia, oversensing
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Mar 30, 2026 · Open, Classified
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Mar 30, 2026 · Open, Classified
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Sep 6, 2024 · Open, Classified
Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
Evidence
Safety, performance, and remote programming utilization of an insertable cardiac monitor: The LUX-Dx PERFORM study.
Richards M, et al. · 2026
Preliminary results from the LUX-Dx insertable cardiac monitor remote programming and performance (LUX-Dx PERFORM) study.
Stolen C, et al. · 2022
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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