LUX-Dx II+ Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Insertable Cardiac Monitor (ICM/ILR) · First cleared Aug 2023
Total Reports
381
Reports (30d)
23
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Brady Monitoring Value Discrepancy
retrospective, brady monitor, brady, value enabled, brady monitoring
133
reports
Connection Failure with Mobile Monitor
insertable cardiac, battery, adverse, icm device, effects
43
reports
Programmed Settings Discrepancy with Pause
pause, settings displayed, displayed latitude, programmed settings, discrepancy
12
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.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 44,929 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 37,761 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 37,430 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 28,090 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 19,969 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,531 reports
Want automated safety signal detection?
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.
Get Early AccessUnderstanding this data