MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Aug 1996 · 2 device variants grouped
Total Reports
1,913
Reports (30d)
17
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
High Thresholds in Atrial Lead
lead explanted, thresholds lead, lead capped, days, fracture
7
reports
Abrupt Impedance Changes in RV Lead
event patient, patient complications, reported right, patient experienced, result event
6
reports
Undersensing During Atrial Events
tachycardia atrial, resulting termination, events resulting, progress lead, times lead
5
reports
Undersensing and Misclassification of Events
episode, misclassification, tachycardia, ventricular tachycardia, resulting
2
reports
Termination of Detected Atrial Events
termination, progress, events, resulting termination, detected events
2
reports
Oversensing Leading to Misclassification of Episodes
noise, exhibited oversensing, episode, misclassification, resulting
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
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