OmniaSecure MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Apr 2025
Total Reports
203
Reports (30d)
39
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Left Lead Oversensing Post-Implant
left, wave oversensing, use, twos, oversensing
20
reports
Helix Stuck During Implant Procedure
attempted, lead implanted, resolve event, implant procedure, helix
14
reports
ICD System Explant Due to Infection
icd, implantable cardioverter, infection, pocket, cardioverter defibrillator
8
reports
High Thresholds and Loss of Capture
lead remains, thresholds, use, use right, capture
5
reports
T-Wave Oversensing Observed
oversensing twos, lead remains, wave oversensing, use, twos
5
reports
T-Wave Oversensing Post-Implant
oversensing twos, wave oversensing, reprogramming, use, twos
4
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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