OmniaSecure MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Apr 2025 · 5 device variants grouped
Total Reports
555
Reports (30d)
97
Active Signals
3
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Rising Shock Impedance with Noise-Induced Pacing Inhibition
ventricular, right, impedance, right ventricular, ventricular lead
144
reports
RV Lead Vegetation with Bacteremia
implantable cardioverter, icd, right, cardioverter, cardioverter defibrillator
20
reports
Lead Oversensing with Abnormal Impedance
additional information, updated, received file, events reported, file updated
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Sep 17, 2026 · Open, Classified
Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.
Evidence
Related research
High predicted durability for the novel small-diameter OmniaSecure defibrillation lead
George H. Crossley, et al. · Heart Rhythm · 2024
Deep septal pacing and subsequent individualized interventricular electrical optimization in HCM with preserved ejection fraction and high anticipated pacing burden: a case report
Ali Hakan Konuş · Frontiers in Cardiovascular Medicine · 2026
Citations indexed from PubMed.
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