TRANSVENOUS LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
368
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Out-of-Specification Lead Analysis
leads, right ventricular, ventricular lead
2
reports
Far Field R-Wave Oversensing
exhibited far, wave ffrw, field wave, ffrw oversensing, far field
1
reports
Infection Leading to Pacing Lead Explantation
infection, experienced infection, patient complications, complications, patient experienced
1
reports
Lead Dislodged and Replaced
lead explanted, lead dislodged, dislodged, explanted replaced, replaced right
1
reports
Undersensing During AF Events
tachycardia atrial, undersensing atrial, termination detected, fibrillation stored, stored episodes
1
reports
Undersensing Leading to Patient Complications
event patient, patient complications, patient experienced, ventricular lead, result event
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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