ACHIEVE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Catheter, Electrode Recording (EP Diagnostic) · First cleared Mar 2011
Total Reports
1,222
Reports (30d)
13
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
15
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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