FINELINE II EZ Sterox Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1997 · 6 device variants grouped
Total Reports
6,002
Reports (30d)
55
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
RA Lead Replaced Due to Performance Anomaly
effects, right ventricular, reported right, additional adverse, ventricular lead
32
reports
RA Lead Explanted During Infection Revision
lead explanted, infection, effects, reported lead, additional adverse
28
reports
Noisy Signals and High Impedance Measurements
noise, crt, adverse, remains service, effects
25
reports
Lead Explanted and Replaced for Unknown Reason
adverse, infection, effects, reported lead, additional adverse
4
reports
Lead Explanted During Infection Revision
adverse, lead explanted, infection, effects, implantable
4
reports
Lead Not Used Due to Placement Difficulty
attempted, lead attempted, replaced implant, attempted used, used
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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