BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Mar 2015
Total Reports
809
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Thromboembolism Death Event
data, terms, single patient, captured separately, event terms
7
reports
Literature Batch: Device Explantation Events
terms apply, data, terms, multiple event, event terms
4
reports
Literature Batch: Hospitalization Events
data, terms, single patient, captured separately, event terms
4
reports
Literature Batch: CVA Death Events
data, terms, single patient, captured separately, event terms
2
reports
Literature Batch: CVA Serious Injury Events
data, terms, single patient, captured separately, event terms
2
reports
Device Migration with Peri-Device Leak
performed watchman, leak, closure procedure, procedure performed, occurred
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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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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