BioMonitor IIIm Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Insertable Cardiac Monitor (ICM/ILR) · First cleared Apr 2020
Total Reports
438
Reports (30d)
10
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Unable to Interrogate
additional information, updated, received file, file updated, updated device
18
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
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Bisignani G, et al. · Frontiers in cardiovascular medicine · 2024
Evaluation of a novel PVC and PAC detection algorithm in an implantable cardiac monitor for longitudinal risk monitoring.
Marmerstein J, et al. · Heart rhythm O2 · 2023
Implantable Loop Recorder with Long Sensing Vector: Safety, Acceptability, and Sensing Performance in Pediatric Patients
Giovanni Domenico Ciriello, et al. · Pediatric Cardiology · 2022
Ventricular Arrhythmia and Cardiac Fibrosis in Endurance Experienced Athletes (VENTOUX).
Javed W, et al. · Circulation. Cardiovascular imaging · 2025
Citations indexed from PubMed.
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