MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Sep 1986 · 2 device variants grouped
Total Reports
480
Reports (30d)
6
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
High Thresholds in Atrial Lead
thresholds lead, days, fracture, thresholds, wave
2
reports
Fracture and High Impedance in Atrial Lead
impedance, high impedance, fracture, capped replaced, replaced right
1
reports
High Capture Thresholds in Atrial Lead
thresholds lead, remain use, thresholds, exhibited high, capture
1
reports
Infection Leading to Lead Explant
infection, experienced infection, event patient, patient complications, patient experienced
1
reports
Low Impedance and High Thresholds in Leads
impedance, high impedance, leads, exhibited high, ventricular lead
1
reports
Out of Range Low Impedance in Atrial Lead
impedance, switch, polarity, range, impedance lead
1
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. 1 active signal detected right now.
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