Epsila EV MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Oct 2023
Total Reports
1,351
Reports (30d)
84
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Extravascular Lead P-Wave Oversensing
wave oversensing, extravascular lead, use, wave, oversensing
155
reports
ICD System Explanted for Infection
implantable cardioverter, infection, cardioverter defibrillator, defibrillator icd, result event
10
reports
Congestive Heart Failure Cause of Death
implantable cardioverter, cardioverter, cardioverter defibrillator, defibrillator icd, extravascular
2
reports
Lead Explanted for Under-Sensing
revision, dislodgement, leads, reported lead, explanted replaced
2
reports
Lead Capped Due to Oversensing
monitoring, received file, lead capped, file updated, oversensing
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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