MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
178
Reports (30d)
4
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Explant Due to Product Performance Issue
adverse, infection, effects, service, additional adverse
3
reports
Infection Leading to Lead Explantation
infection, experienced infection, event patient, patient complications, result event
2
reports
High Impedance Triggered Lead Safety Switch
adverse, impedance, effects, range, service
1
reports
Loss of Capture Noted
left, intermittent, loss capture, ventricular lead, capture
1
reports
Rising Impedance in Atrial Lead
adverse, impedance, effects, range, service
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
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