BioMonitor IV Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Insertable Cardiac Monitor (ICM/ILR) · First cleared May 2023
Total Reports
104
Reports (30d)
6
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Template Summary: Device Interrogation Failure
additional information, updated, received file, file updated, updated device
15
reports
False Atrial Fibrillation Episode Counts
electrocardiogram, episodes, episode, data, counters
1
reports
Low Battery Alert During Implant
insertable cardiac, adverse, icm device, effects, service
1
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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