RA LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
330
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Noisy Signals and High Impedance Measurements
noise, crt, adverse, remains service, effects
7
reports
RA Lead Replaced Due to Performance Anomaly
effects, right ventricular, reported right, additional adverse, ventricular lead
3
reports
RA Lead Explanted During Infection Revision
lead explanted, infection, effects, reported lead, additional adverse
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
Evidence
Related research
Citations indexed from PubMed.
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