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
377
Reports (30d)
3
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Thresholds and Undersensing Post-Implant
pulse, implantable pulse, generator, generator ipg, ipg
1
reports
High Thresholds in Right Ventricular Lead
thresholds lead, right ventricular, thresholds, ventricular lead, high thresholds
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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