BOSTON SCIENTIFIC CORPORATION · Insertable Cardiac Monitor (ICM/ILR) · First cleared Jun 2020
Total Reports
117
Reports (30d)
9
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Brady and Pause Monitoring DiscrepancyEmerging
pause, settings displayed, programmed settings, management information, data
2
reports
Premature Battery Depletion Analysis
insertable cardiac, battery, adverse, icm device, effects
5
reports
Brady Monitoring Value Discrepancy
brady monitor, data, brady, value enabled, brady monitoring
3
reports
False Pause Episode Due to Undersensing
noise, episodes, false, tachycardia, oversensing
2
reports
Device Explanted Due to Infection
explanted, insertable cardiac, adverse, icm device, effects
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
Heart Failure Remote Monitoring: A Review and Implementation How-To.
Kobe EA, et al. · 2023
Echocardiographic Markers of Prognosis in Patients Undergoing Ventricular Arrhythmia Ablation.
Duus LS, et al. · 2025
Subcutaneous sensors for monitoring congestion and to reduce heart failure hospitalizations-a viable middle ground between deep implantable intravascular monitoring devices and wearable technologies?
Wetterling F, et al. · 2025
Invasive and Non-Invasive Remote Patient Monitoring Devices for Heart Failure: A Comparative Review of Technical Maturity and Clinical Readiness.
Luque I, et al. · 2025
Incident Arrhythmias Detected Using Implantable Loop Recorders in Obstructive Sleep Apnoea.
He H, et al. · 2025
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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