OmniaSecure MRI SureScanRecalls & reported problems across all models
Medtronic, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 302
- Deaths reported
- 4
- Injuries reported
- 132
- Recalls
- 0
We found 2 models of OmniaSecure MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 302 adverse event reports in the FDA's MAUDE database, received between Jan 15, 2026 and Sep 30, 2026 — classified as 4 deaths, 132 injuries, 166 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (141 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OmniaSecure MRI SureScan problems
Device problems
- Over-Sensing141
- Device Dislodged or Dislocated38
- Adverse Event Without Identified Device or Use Problem28
- Positioning Problem28
- Decreased Sensitivity26
- Detachment of Device or Device Component21
- High Capture Threshold20
- Failure to Capture18
Patient problems
- No Clinical Signs, Symptoms or Conditions244
- Shock from Patient Lead(s)10
- Bradycardia8
- Unspecified Infection8
- Medical device site infection6
- Purulent Discharge6
- Bacterial Infection5
- Syncope/Fainting5
OmniaSecure MRI SureScan models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OmniaSecure™ MRI SureScan™ 3930M74Permanent defibrillator electrodes3 deaths228 reports
- OmniaSecure™ MRI SureScan™ 3930M79Permanent defibrillator electrodes1 death74 reports
Recent OmniaSecure MRI SureScan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Over-Sensing
It was reported that Left Bundle Branch Area Pacing (LBBAP) lead triggered a Lead Integrity Alert (LIA) for High Rate Non-Sustained episodes and elevated Sensing Integrity Counter (SIC). The lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951036 ↗MalfunctionSep 29, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938814 ↗MalfunctionSep 29, 2026Over-Sensing
It was reported that the Left Bundle Branch Area Pacing (LBBAP) lead exhibited P-wave Oversensing (PWOS) and low R-wave measurements. It was noted that the patient has Ventricular Tachycardia (VT) causing challenges with programming around sensing issues. The lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937029 ↗InjurySep 29, 2026Device Dislodged or Dislocated
It was reported that the Right Ventricular (RV) lead dislodged. The RV lead was explanted and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936078 ↗MalfunctionSep 29, 2026Positioning Problem
It was reported that the customer called to inquire about a sensation they were experiencing with their implanted Implantable Cardioverter Defibrillator (ICD), specifically feeling as though the device had turned or the wires were positioned differently than before. The customer was concerned about whether this was normal and if it could affect the device functionality. The Implantable Cardioverter Defibrillator (ICD) system remains in use. No patient complications have been reported as a result of this event.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50935951 ↗MalfunctionSep 28, 2026Signal Artifact/Noise; High impedance; Over-Sensing
It was reported that the Right Ventricular (RV) lead triggered multiple alerts for high undefined pacing impedance. Additionally, P-wave Oversensing (PWOS), High Rate Non-Sustained episodes, and noise were observed on the RV lead. The RV lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920296 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917959 ↗MalfunctionSep 28, 2026Over-Sensing; Decreased Sensitivity
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916047 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacterial Infection; Fungal Infection; Medical device site infection
MAUDE report 50904001 ↗InjurySep 25, 2026Over-Sensing; Device Dislodged or Dislocated
Patient problems: Palpitations
MAUDE report 50903740 ↗InjurySep 25, 2026Over-Sensing
It was reported that post-implant procedure the Right Ventricular (RV) lead, placed in the Left Bundle Branch, exhibited T-Wave Oversensing (TWOS) post ventricular pacing, and reprogramming was performed. The RV lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899608 ↗MalfunctionSep 25, 2026Over-Sensing; Pacing Problem
It was reported that one day post implant, the Right Ventricular (RV) lead, positioned in the Left Bundle Branch Area Pacing (LBBAP), exhibited oversensing resulting in intermittent inhibition of pacing. The lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898197 ↗MalfunctionSep 24, 2026Failure to Capture; High impedance; Low impedance; Positioning Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890115 ↗InjurySep 24, 2026Over-Sensing
It was reported that following implant of the Right Ventricular (RV), Left Bundle Branch Area Pacing (LBBAP) lead, the lead exhibited T-Wave Oversensing (TWOS) post Ventricular Pacing. The ventricular blanking period post ventricular pacing was adjusted. The RV lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887432 ↗InjurySep 24, 2026High Capture Threshold
It was reported that the Left Bundle Branch Area Pacing (LBBAP) lead exhibited high thresholds. The lead was reprogrammed and remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886207 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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