MEDTRONIC, INC. · Catheter, Electrode Recording (EP Diagnostic) · First cleared Mar 2011
Total Reports
1,206
Reports (30d)
8
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Mapping Catheter Kinking During Cryo Ablation
cryo, issue case, case completed, balloon, completed cryo
13
reports
Pericardial Effusion Post-Ablation
right, pericardial effusion, pericardial, effusion, pericardiocentesis
1
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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Advisor HD Grid, Sensor Enabled
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ACHIEVE ADVANCE
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OCTARAY Mapping Catheter
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DECANAV
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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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