ACHIEVE ADVANCE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Catheter, Electrode Recording (EP Diagnostic) · First cleared Nov 2016
Total Reports
339
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Broken Shaft During Cryo Ablation Prep
cryo, cryo ablation, case completed, completed cryo, umbilical cable
2
reports
Cardiac Perforation Requiring Pericardiocentesis
decided, heart, perforation, effusion, pericardiocentesis
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
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