MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Sep 1986 · 2 device variants grouped
Total Reports
3,240
Reports (30d)
56
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
High Thresholds in Atrial Lead
lead explanted, thresholds lead, replaced patient, event right, days
15
reports
Undersensing During Atrial Events
pacing times, tachycardia atrial, resulting termination, implant right, atrial fibrillation
10
reports
Termination of Detected Atrial Events
termination, progress, events, resulting termination, detected events
7
reports
Infection Leading to CRT Device Explant
cardiac resynchronization, crt, infection, resynchronization therapy, crt explanted
5
reports
Fractured Pacing Lead During Implant
pacing lead, attempted, lead attempted, attempted used, used
5
reports
High Thresholds During Implant Procedure
attempted, lead attempted, attempted used, implant procedure, used
5
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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