FINELINE II Sterox Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1997
Total Reports
819
Reports (30d)
6
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted During Infection Revision
adverse, lead explanted, infection, effects, implantable
2
reports
Noisy Signals and High Impedance Measurements
noise, crt, adverse, remains service, effects
2
reports
RA Lead Explanted During Infection Revision
lead explanted, infection, effects, reported lead, additional adverse
2
reports
RA Lead Replaced Due to Performance Anomaly
effects, right ventricular, reported right, additional adverse, ventricular lead
2
reports
Lead Explanted and Replaced for Unknown Reason
adverse, infection, effects, reported lead, additional adverse
1
reports
Lead Not Used Due to High Thresholds
attempted, replaced implant, implant procedure, used, helix
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,089 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 38,723 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 38,006 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,057 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,299 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,625 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data