MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1996
Total Reports
27,017
Reports (30d)
496
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Undersensing During Atrial Events
pacing times, tachycardia atrial, resulting termination, implant right, times lead
145
reports
Abrupt Impedance Changes in RV Lead
event patient, patient complications, reported right, patient experienced, result event
76
reports
Infection Leading to CRT Device Explant
cardiac resynchronization, crt, infection, resynchronization therapy, crt explanted
66
reports
Termination of Detected Atrial Events
termination, progress, events, resulting termination, detected events
61
reports
Far Field Oversensing in Atrial Lead
exhibited far, ffrw, wave ffrw, field wave, ffrw oversensing
38
reports
RA Lead Dislodged Post-Implant
lead explanted, implant right, lead dislodged, dislodged, post implant
37
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. 2 active signals detected right now.
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