BIOTRONIK SE & Co. KG · Insertable Cardiac Monitor (ICM/ILR) · First cleared Jul 2019
Total Reports
696
Reports (30d)
6
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Device Explanted Due to Noise
explanted, noise, battery, adverse, additional information
11
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
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
Diagnostic yield of an insertable cardiac monitor in a large patient population
Dennis H. Lau, et al. · Heart Rhythm O2 · 2022
Programming Optimization in Implantable Cardiac Monitors to Reduce False-Positive Arrhythmia Alerts: A Call for Research
Fabrizio Guarracini, et al. · Diagnostics · 2022
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
P-wave detection performance of the BioMonitor III, Confirm Rx and Reveal Linq implantable loop recorders
Tobias Schreiber, et al. · Journal of Electrocardiology · 2022
Citations indexed from PubMed.
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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.
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