MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead)
Total Reports
2,262
Reports (30d)
22
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Template Summary: FDA Notification
report reflects, received fda, reflects information, fda form, form notification
15
reports
Explanted Lead Due to Performance Issue
report reflects, received fda, form, form notification, notification
11
reports
Low Pacing Impedance Measurements
measurements, remains service, effects, technical services, service adverse
7
reports
High Shock Impedance Measurements
remains service, effects, shock impedance, services, ohms
4
reports
Lead Integrity Alert Triggered
triggered, sensing, alert, use, integrity
2
reports
Right Lead Revision for Infection
explanted right, infection additional, effects, reported lead, revision infection
2
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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