CAPSURE SP Novus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1998 · 2 device variants grouped
Total Reports
3,935
Reports (30d)
57
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Premature Battery Depletion in IPG
implantable pulse, right ventricular, pulse generator, generator ipg, ipg
9
reports
Undersensing During Atrial Events
tachycardia atrial, resulting termination, atrial fibrillation, episodes resulting, fibrillation stored
7
reports
Undersensing in RV Lead with Syncope
event patient, patient complications, complications, experienced, patient experienced
6
reports
Noise Oversensing in RV Lead
noise, right ventricular, use right, ventricular lead, oversensing
6
reports
Infection and Erosion Post-Implant
implantable pulse, infection, event patient, erosion, pulse generator
6
reports
High Thresholds in RV Lead
thresholds lead, lead explanted, right ventricular, capped replaced, ventricular lead
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
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