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
6,037
Reports (30d)
35
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Revision Due to Infection
infection, effects, revision, reported lead, additional adverse
21
reports
RA Lead Explanted Due to Performance Anomaly
lead explanted, revision, effects, reported right, additional adverse
19
reports
System Revision Due to Infection
adverse, infection, revision, effects, additional adverse
14
reports
Loss of Capture in RA Lead
capture, loss, adverse, impedance, effects
11
reports
Fracture and High Impedance in RV Lead
impedance, fracture, right ventricular, range, ventricular lead
4
reports
RV Lead Capped Due to Performance Issue
effects, right ventricular, reported right, additional adverse, ventricular lead
4
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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