OmniaSecure™ MRI SureScan™ 3930M74Recalls & reported problems
Medtronic, Inc. · LEAD 3930M74 US MKT 74 CM DF4 MR EN · Class 3 · Implant
All models of OmniaSecure MRI SureScan (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic OmniaSecure defibrillator lead has 211 adverse event reports, with 2 deaths and 101 injuries. Many describe the lead picking up false heart signals, or being dislodged or hard to place, and a few describe a puncture of the heart wall or an infection requiring removal. All of the reports were filed in the past year. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 228
- Deaths reported
- 3
- Injuries reported
- 104
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 228 adverse event reports that list this exact device (DI 00763000643430), received between Jan 21, 2026 and Sep 29, 2026 — classified as 3 deaths, 104 injuries, 121 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (101 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Over-Sensing101
- Device Dislodged or Dislocated30
- Adverse Event Without Identified Device or Use Problem24
- Positioning Problem19
- Decreased Sensitivity18
- Detachment of Device or Device Component17
- High Capture Threshold15
- Failure to Capture13
Patient problems
- No Clinical Signs, Symptoms or Conditions181
- Shock from Patient Lead(s)7
- Unspecified Infection7
- Medical device site infection6
- Purulent Discharge6
- Syncope/Fainting5
- Bacterial Infection4
- Bradycardia4
Recent adverse event reports
The 25 most recent of 228 reports, in the reporter's own words as published by the FDA.
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 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 ↗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 ↗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, 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 ↗InjurySep 23, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Positioning Problem
Patient problems: Shock from Patient Lead(s)
MAUDE report 50875957 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829557 ↗MalfunctionSep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the lead was returned to the manufacturer, analyzed, and tested out of specification. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818154 ↗InjurySep 17, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809192 ↗MalfunctionSep 17, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS). 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 50802420 ↗InjurySep 16, 2026Low impedance; Decreased Sensitivity; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited out of range low pacing impedance, high thresholds, and diminished sensing. It was noted that the lead integrity was compromised during a Ventricular Tachycardia (VT) ablation. The 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 50793836 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779638 ↗MalfunctionSep 15, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778735 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to a pocket infection, erosion, and purulent discharge. No further patient complications have been reported as a result of this event.
Patient problems: Erosion; Purulent Discharge; Unspecified Infection
MAUDE report 50757009 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component
It was reported that the Right Ventricular (RV) lead was difficult to place due to the patient's dilated heart. The lead was not used and a longer replacement lead was implanted. The lead was returned to the manufacturer, analyzed and tested out of specification.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753230 ↗InjurySep 10, 2026Device Dislodged or Dislocated
It was reported that the Left Bundle Branch Area Pacing (LBBAP) lead was explanted and replaced due to dislodgement. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720259 ↗InjurySep 10, 2026High Capture Threshold
It was reported that approximately 10 days post implant, the Right Ventricular (RV) lead was explanted and replaced due to high thresholds. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50704753 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
The lead was returned to the manufacturer after electively not being implanted due to the patient's anatomy and subsequently tested out of specification during manufacturer's analysis. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695343 ↗MalfunctionSep 9, 2026Material Twisted/Bent
It was reported that during the implant procedure, the Right Ventricular (RV) lead was taken out of the sterile packing and it was discovered that the helix was bent. A different RV lead of the same model and length was able to be implanted successfully. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690247 ↗MalfunctionSep 8, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678591 ↗
Other Permanent defibrillator electrodes devices
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes333 deaths30,581 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Medtronic, Inc. · Permanent defibrillator electrodes221 deaths14,405 reports
- Capsurefix® Novus 5076-52Medtronic, Inc. · Permanent defibrillator electrodes111 deaths9,860 reports
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes80 deaths8,280 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55Medtronic, Inc. · Permanent defibrillator electrodes116 deaths7,750 reports
- Durata™ 7122Q-58St. Jude Medical, Inc. · Permanent defibrillator electrodes151 deaths6,202 reports
- Durata™ 7122Q-65St. Jude Medical, Inc. · Permanent defibrillator electrodes86 deaths4,773 reports
- Capsurefix® Novus 5076-58Medtronic, Inc. · Permanent defibrillator electrodes47 deaths4,587 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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