CRYSTALLINE ACTFIX Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
307
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Undersensing in Right Ventricular Lead
pacing lead, exhibited undersensing, undersensing resulting, right ventricular, ventricular lead
2
reports
Helix Malfunction During Implant Attempt
attempted used, used, helix, pacing lead, attempted
1
reports
Loss of Capture and Undersensing in Atrial Lead
sensing, leads, loss capture, egm, capture
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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