CRYSTALLINE ACTFIX Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
313
Reports (30d)
3
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Far Field Oversensing Triggering False Detections
exhibited far, false, field wave, far field, oversensing triggering
1
reports
RA and RV Leads Exhibited Oversensing
exhibited oversensing, remain use, right ventricular, ventricular lead, oversensing
1
reports
Replaced Right / Thresholds / Exhibited High
thresholds lead, thresholds, exhibited high, replaced right, high thresholds
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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