CAPSUREFIX Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1996
Total Reports
173
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
CRT-D System Explanted Due to Infection
cardiac resynchronization, crt, infection, crt explanted, resynchronization therapy
1
reports
Far Field R-Wave Oversensing Detected
ffrw, wave ffrw, field wave, ffrw oversensing, far field
1
reports
Ffrw Oversensing / Wave Ffrw / Field Wave
exhibited far, wave ffrw, field wave, ffrw oversensing, far field
1
reports
Undersensing During Atrial Fibrillation Events
episodes resulting, detected event, termination detected, fibrillation stored, event progress
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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