Capsure EPI Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Aug 1998 · 2 device variants grouped
Total Reports
2,983
Reports (30d)
24
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead Triggered Multiple Alerts
episodes, non, right ventricular, ventricular lead, oversensing
6
reports
RA Lead Capped and Replaced
lead capped, replaced, right ventricular, capped replaced, ventricular lead
5
reports
Fracture / Replaced Right / Lead Explanted
suspected, lead explanted, fracture, explanted replaced, replaced right
3
reports
Ventricular Lead / Right Ventricular / Capture
right ventricular, loss capture, replaced right, ventricular lead, capture
2
reports
Event Patient / Complications / Patient Complications
event patient, patient complications, complications, experienced, result event
2
reports
Ipg / Pulse Generator / Implantable Pulse
implantable pulse, pulse generator, generator ipg, oversensing, ipg
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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