ACHIEVE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Catheter, Electrode Recording (EP Diagnostic) · First cleared Mar 2011
Total Reports
1,232
Reports (30d)
5
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Broken Mapping Catheter Before Procedure
broken, cryo, cryo ablation, electrodes, removal
12
reports
Pericardial Effusion from Catheter Kinking
pericardial effusion, decanav catheter, pericardial, effusion, decanav
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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