CAPSURE SP Novus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Sep 1986 · 2 device variants grouped
Total Reports
3,877
Reports (30d)
32
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Ventricular Lead / Right Ventricular / Oversensing
exhibited oversensing, exhibited noise, right ventricular, ventricular lead, oversensing
4
reports
Switch / Impedance / Ventricular Lead
impedance, switch, right ventricular, use right, ventricular lead
4
reports
IPG Explanted with Erosion and Infection
infection, event patient, patient complications, complications, patient developed
4
reports
Egm / Electrograms Egm / Right Ventricular
right ventricular, electrograms egm, egm, ventricular lead, stored
4
reports
IPG Explanted Due to Infection Post Replacement
generator, infection, pulse generator, ipg explanted, ipg
3
reports
Undersensing Resulting in Unnecessary Pacing
resulting termination, events resulting, times lead, undersensing atrial, episodes resulting
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Citations indexed from PubMed.
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