BioMonitor IV Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Insertable Cardiac Monitor (ICM/ILR) · First cleared May 2023
Total Reports
108
Reports (30d)
4
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Migration with Loss of Sensing
additional information, updated, device explanted, file updated, updated device
14
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
Citations indexed from PubMed.
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