CapSureFix Novus MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1996
Total Reports
29,057
Reports (30d)
437
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
44
reports
Undersensing Resulting in Termination of Events
termination, tachycardia atrial, atrial fibrillation, events, atrial tachycardia
35
reports
ICD Explanted Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
34
reports
Undersensing Resulting in Unnecessary Pacing
resulting unnecessary, pacing times, tachycardia atrial, resulting termination, times lead
33
reports
Undersensing During Atrial Fibrillation Events
termination, tachycardia atrial, resulting termination, episodes resulting, fibrillation stored
32
reports
Far Field R-Wave Oversensing Detected
exhibited far, ffrw, wave ffrw, field wave, ffrw oversensing
30
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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