CapSureFix Novus MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1996 · 4 device variants grouped
Total Reports
29,710
Reports (30d)
357
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Undersensing During Atrial Events
event patient, atrial fibrillation, episodes resulting, fibrillation stored, patient experienced
136
reports
Far Field R-Wave Oversensing
exhibited far, ffrw, wave ffrw, field wave, wave
64
reports
CRT-D Explanted Due to Infection
cardiac resynchronization, crt, infection, crt explanted, resynchronization therapy
37
reports
Undersensing During Atrial Fibrillation
episodes resulting, fibrillation stored, event progress, detected event, undersensing atrial
26
reports
Premature Battery Depletion in IPG
implantable pulse, right ventricular, pulse generator, generator ipg, ipg
23
reports
RA Lead Dislodged Post-Implant
lead explanted, implant right, lead dislodged, post implant, explanted replaced
22
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
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