BioMonitor IIIm Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Insertable Cardiac Monitor (ICM/ILR) · First cleared Apr 2020
Total Reports
428
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Unable to Interrogate Device
additional information, updated, received file, file updated, updated device
12
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Implantable cardiac monitors: artificial intelligence and signal processing reduce remote ECG review workload and preserve arrhythmia detection sensitivity
Giovanni Bisignani, et al. · Frontiers in Cardiovascular Medicine · 2024
Implantable loop recorder migration: Case-based review and implications for clinical practice
Allam Harfoush · American Heart Journal Plus Cardiology Research and Practice · 2025
Implantable Loop Recorder with Long Sensing Vector: Safety, Acceptability, and Sensing Performance in Pediatric Patients
Giovanni Domenico Ciriello, et al. · Pediatric Cardiology · 2022
Evaluation of a novel PVC and PAC detection algorithm in an implantable cardiac monitor for longitudinal risk monitoring
Joseph T. Marmerstein, et al. · Heart Rhythm O2 · 2023
Citations indexed from PubMed.
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