CAPSUREFIX Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1996
Total Reports
174
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Far Field R-Wave Oversensing
wave ffrw, field wave, ffrw oversensing, far field, far
1
reports
High Thresholds in RA Lead
thresholds lead, lead capped, exhibited high, replaced right, high thresholds
1
reports
Oversensing and Misclassification in RA Lead
noise, resulting misclassification, episode, misclassification episode, misclassification
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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