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
3,043
Reports (30d)
43
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
10
reports
High Impedance in RV Lead
impedance, lead reprogrammed, right ventricular, use right, impedance lead
7
reports
Far Field R-Wave Oversensing
exhibited far, ffrw, wave ffrw, field wave, ffrw oversensing
6
reports
Pacing Lead Dislodged and Replaced
pacing lead, lead explanted, fracture, lead dislodged, explanted replaced
5
reports
CRT-D Explanted Due to Infection
cardiac resynchronization, crt, infection, crt explanted, resynchronization therapy
5
reports
Oversensing and Misclassification in RV Lead
exhibited oversensing, episodes, non, right ventricular, oversensing
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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