CapsureSP Novus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Sep 1986 · 2 device variants grouped
Total Reports
380
Reports (30d)
2
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Ipg / Pulse / Implantable Pulse
pulse, implantable pulse, pulse generator, generator ipg, ipg
1
reports
IPG Explanted Due to Infection
infection, event patient, pulse generator, ipg explanted, infection implantable
1
reports
RA Lead Loss of Capture Detected
thresholds lead, right ventricular, capped replaced, ventricular lead, replaced right
1
reports
Right Ventricular / Ventricular Lead / Impedance
impedance, right ventricular, impedance lead, use right, ventricular lead
1
reports
Ventricular Lead / Right Ventricular / Capture
right ventricular, loss capture, replaced right, ventricular lead, capture
1
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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