FLEXTEND Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Pacemaker Electrode (Lead) · First cleared Nov 1998 · 3 device variants grouped
Total Reports
2,504
Reports (30d)
12
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Loss of Capture in RA Lead
capture, loss, adverse, impedance, effects
9
reports
Revision Due to Infection
infection, effects, revision, reported lead, additional adverse
5
reports
RV Lead Capped Due to Performance Issue
effects, right ventricular, reported right, additional adverse, ventricular lead
5
reports
System Revision Due to Infection
adverse, infection, revision, effects, additional adverse
4
reports
Fracture and High Impedance in RV Lead
impedance, fracture, right ventricular, range, ventricular lead
3
reports
RA Lead Explanted Due to Performance Anomaly
lead explanted, revision, effects, reported right, additional adverse
3
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
Yaminisharif A, et al. · International cardiovascular research journal · 2014
Perforation of the right ventricle during cardiac resynchronisation therapy upgrade not related to a coexisting persistent left superior vena cava.
Providência R, et al. · BMJ case reports · 2012
Citations indexed from PubMed.
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