CAPSUREFIX Novus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1996 · 9 device variants grouped
Total Reports
46,344
Reports (30d)
253
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Undersensing During Atrial Events
event patient, atrial fibrillation, episodes resulting, fibrillation stored, patient experienced
106
reports
Far Field R-Wave Oversensing
exhibited far, ffrw, wave ffrw, field wave, wave
73
reports
Premature Battery Depletion in IPG
right ventricular, ipg, implantable pulse, pulse generator, generator ipg
40
reports
Low Impedance in RA Lead
undefined, remain use, right ventricular, exhibited high, low impedance
36
reports
Undersensing on Stored Electrograms
egm, stored, tachycardia atrial, right ventricular, atrial tachycardia
31
reports
Undersensing in RV Lead
pacing lead, undersensing, use right, right ventricular, exhibited undersensing
30
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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