BOSTON SCIENTIFIC CORPORATION · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1997
Total Reports
792
Reports (30d)
8
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Infection Leading to RV Lead Explant
lead explanted, infection, effects, revision, additional adverse
6
reports
Infection Leading to Lead Explant
adverse, lead explanted, infection, revision, effects
5
reports
Ventricular Lead Explanted Due to Performance Issues
lead explanted, effects, additional adverse, ventricular lead, explanted
2
reports
High Pacing Thresholds in Ventricular Lead
adverse, effects, reported right, additional adverse, ventricular lead
2
reports
High Out of Range Impedance in Ventricular Lead
adverse, impedance, effects, range, service
2
reports
Lead Abandoned Due to Performance Issues
chest, effects, reported right, service, additional adverse
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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