BioMonitor III Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Insertable Cardiac Monitor (ICM/ILR) · First cleared Jul 2019
Total Reports
706
Reports (30d)
1
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
5
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
‘Close’ cardiac monitoring: life-threatening complication of a loop recorder implant
Zaki Akhtar, et al. · EP Europace · 2021
New-generation miniaturized insertable cardiac monitor with a long sensing vector: Insertion procedure, sensing performance, and home monitoring transmission success in a real-world population
Thomas Deneke, et al. · Heart Rhythm O2 · 2022
Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success
Justin A. Mariani, et al. · Journal of Electrocardiology · 2020
The BIOMONITOR III Injectable Cardiac Monitor: Clinical Experience with a Novel Injectable Cardiac Monitor
Nico Reinsch, et al. · Journal of Clinical Medicine · 2022
Diagnostic yield of an insertable cardiac monitor in a large patient population
Dennis H. Lau, et al. · Heart Rhythm O2 · 2022
Citations indexed from PubMed.
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