FINELINE II Sterox Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1997 · 6 device variants grouped
Total Reports
2,022
Reports (30d)
9
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Loss of Capture in RA Lead
capture, loss, adverse, impedance, effects
5
reports
System Revision Due to Infection
adverse, infection, revision, effects, additional adverse
5
reports
RA Lead Explanted Due to Performance Anomaly
lead explanted, revision, effects, reported right, additional adverse
5
reports
Undersensing in RV Lead with Syncope
event patient, patient complications, complications, experienced, patient experienced
2
reports
RV Lead Capped Due to Performance Issue
effects, right ventricular, reported right, additional adverse, ventricular lead
2
reports
High Thresholds in RV Lead
lead explanted, right ventricular, explanted replaced, replaced right, explanted
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
Comparative study about the tensile strength and yielding mechanism of pacing lead among major manufacturers.
Chan CW, et al. · Pacing and clinical electrophysiology : PACE · 2018
Long-term reliability of sweet-tip type screw-in leads.
Takano A, et al. · Journal of arrhythmia · 2016
Atrial lead perforation early after device implantation—a case report and literature review
Zefeng Wang, et al. · Frontiers in Surgery · 2024
Citations indexed from PubMed.
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