LUX-Dx Insertable Cardiac Monitor Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Insertable Cardiac Monitor (ICM/ILR) · First cleared Sep 2025
Total Reports
566
Reports (30d)
3
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Premature Battery Depletion with Unknown Cause
insertable cardiac, adverse, icm device, effects, service
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
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
Related research
Safety, performance, and remote programming utilization of an insertable cardiac monitor: The LUX-Dx PERFORM study
Mark Richards, et al. · Heart Rhythm O2 · 2026
Monitoring of Remotely Reprogrammable Implantable Loop Recorders With Algorithms to Reduce False‐Positive Alerts
Zachary Neiman, et al. · Journal of the American Heart Association · 2024
Preliminary results from the LUX‐Dx insertable cardiac monitor remote programming and performance (LUX‐Dx PERFORM) study
Craig Stolen, et al. · Clinical Cardiology · 2022
Citations indexed from PubMed.
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