TRANSVENOUS LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
379
Reports (30d)
3
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Capped and Replaced
lead capped, impedance, lead reprogrammed, reported lead, explanted
1
reports
Noise and Oversensing in RA Lead
noise, exhibited oversensing, exhibited noise, use right, oversensing
1
reports
Noise Oversensing in RV Lead
noise, right ventricular, use right, ventricular lead, oversensing
1
reports
Oversensing in RA Lead
exhibited oversensing, intermittent, use right, oversensing lead, oversensing
1
reports
Undersensing During Atrial Events
resulting termination, exhibited undersensing, undersensing, termination detected, fibrillation stored
1
reports
Undersensing in RV Lead with Syncope
event patient, patient complications, complications, experienced, patient experienced
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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