FLEXTEND Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Pacemaker Electrode (Lead) · First cleared Nov 1998 · 3 device variants grouped
Total Reports
2,492
Reports (30d)
23
Active Signals
0
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
14
reports
RA Lead Explanted During Infection Revision
lead explanted, infection, effects, reported lead, additional adverse
7
reports
RA Lead Replaced Due to Performance Anomaly
effects, right ventricular, reported right, additional adverse, ventricular lead
7
reports
Lead Explanted During Infection Revision
adverse, lead explanted, infection, effects, implantable
3
reports
RA Lead Explanted Due to Infection
infection, event patient, patient complications, complications, result event
1
reports
Undersensing / Exhibited Undersensing / Ventricular Lead
exhibited undersensing, undersensing, right ventricular, use right, ventricular lead
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
High-power chargers for electric vehicles: are they safe for patients with pacemakers and defibrillators?
Lennerz C, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
Citations indexed from PubMed.
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