BOSTON SCIENTIFIC CORPORATION · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1997 · 6 device variants grouped
Total Reports
5,804
Reports (30d)
80
Active Signals
8
Open Recalls
0
What the reports describe · Claripulse analysis
Infection Leading to Lead Explant
adverse, lead explanted, infection, experienced infection, event patient
50
reports
Noisy Signals and Low Impedance in Atrial Lead
adverse, effects, reported right, range, service
36
reports
Infection Leading to RV Lead Explant
lead explanted, infection, effects, revision, additional adverse
7
reports
Lead Abandoned Due to Performance Issues
chest, effects, reported right, service, additional adverse
6
reports
Inappropriate Therapy Delivery by CRT-D
crt, therapy, defibrillator, tachycardia, ventricular tachycardia
5
reports
Ventricular Lead Explanted Due to Performance Issues
lead explanted, effects, additional adverse, ventricular lead, explanted
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Hybrid minimally invasive technique with the bidirectional rotational Evolution® mechanical sheath for transvenous lead extraction: A collaboration between electrophysiologists and cardiac surgeons.
Migliore F, et al. · 2018
Citations indexed from PubMed.
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