CAPSUREFIX Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1996
Total Reports
171
Reports (30d)
4
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Atrial Lead Undersensing During AF
resulting termination, progress lead, detected event, fibrillation stored, event progress
1
reports
Atrial Lead Undersensing on Stored EGM
atrial fibrillation, electrograms egm, egm, electrograms, stored
1
reports
CRT-D Device Explanted Due to Infection
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, therapy defibrillator
1
reports
Loss of Capture and Undersensing in Atrial Lead
sensing, leads, loss capture, egm, capture
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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