ABBOTT (ST. JUDE MEDICAL) · Catheter, Electrode Recording (EP Diagnostic) · First cleared Apr 2018
Total Reports
408
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Catheter Tip Fracture During Procedure
completed adverse, lasso
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
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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