OmniaSecure MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Apr 2025
Total Reports
304
Reports (30d)
40
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Left Lead Oversensing Post-Implant
left, wave oversensing, pacing, use, oversensing
21
reports
Right Lead T-Wave Oversensing
oversensing twos, lead remains, wave oversensing, use, twos
19
reports
Helix Damage During Implant Procedure
lead implanted, patient stable, used, implant procedure, helix
15
reports
Rising Thresholds Post-Implant
post, approximately, thresholds, use, explanted replaced
9
reports
Extravascular ICD System Explanted for Infection
icd, infection, patient complications, extravascular, result event
8
reports
Lead Integrity Alert Triggered
triggered, non, alert, oversensing, integrity
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,343 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 39,061 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 38,591 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,411 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,458 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,669 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
Get Early AccessUnderstanding this data