BioMonitor 2-AF Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Insertable Cardiac Monitor (ICM/ILR) · First cleared Apr 2016
Total Reports
145
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
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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