MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared May 2003
Total Reports
568
Reports (30d)
4
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Infection Leading to CRT Device Explant
cardiac resynchronization, crt, infection, resynchronization therapy, crt explanted
3
reports
High Thresholds in Ventricular Lead
thresholds lead, replaced, implant right, approximately, thresholds
3
reports
Low Impedance and High Thresholds in Leads
impedance, high impedance, leads, exhibited high, ventricular lead
1
reports
Oversensing and Noise in Ventricular Lead
ventricular lead, oversensing, integrity, noise, sensing
1
reports
Undersensing and Loss of Capture in Leads
leads remain, undersensing, remain use, leads, ventricular lead
1
reports
Abrupt Impedance Changes in RV Lead
event patient, patient complications, reported right, patient experienced, result event
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. 1 active signal detected right now.
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