Advisor HD Grid, Sensor Enabled Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Catheter, Electrode Recording (EP Diagnostic) · First cleared Apr 2018
Total Reports
411
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Damaged Catheter Tip During Atrial Flutter Ablation
catheter exchanged, exchanged, pacing wire, procedure decanav, internal
4
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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