OmniaSecure™ MRI SureScan™ 3930M79Recalls & reported problems
Medtronic, Inc. · LEAD 3930M79 US MKT 79 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 MRI SureScan 3930M79 is an implanted defibrillator lead wire that delivers shock therapy to the heart. The 65 reports filed since January 2026 mostly describe the lead picking up signals it shouldn't (over-sensing), plus positioning problems, signal noise, parts detaching, and leads moving out of place. Reports mention 1 death and 25 injuries. Most people had no symptoms beyond the device issue, though some reported slow heart rate, shocks, or palpitations. 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
- 74
- Deaths reported
- 1
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00763000643454), received between Jan 15, 2026 and Sep 30, 2026 — classified as 1 death, 28 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (40 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-Sensing40
- Positioning Problem9
- Decreased Sensitivity8
- Device Dislodged or Dislocated8
- Signal Artifact/Noise6
- Failure to Capture5
- High Capture Threshold5
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- Bradycardia4
- Shock from Patient Lead(s)3
- Dyspnea2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacteremia1
- Bacterial Infection1
- Cardiac Perforation1
Recent adverse event reports
The 25 most recent of 74 reports, 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, 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, 2026Over-Sensing; Decreased Sensitivity
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916047 ↗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 ↗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 23, 2026Failure to Capture; Over-Sensing; Decreased Sensitivity; Capturing Problem; Device Dislodged or Dislocated; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875936 ↗InjurySep 15, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead, implanted in the left bundle branch, post-operatively exhibited T-Wave Oversensing (TWOS). The lead was reprogrammed the day following implant 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 50774319 ↗MalfunctionSep 14, 2026Mechanical Problem; Positioning Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760883 ↗MalfunctionSep 11, 2026Signal Artifact/Noise; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741161 ↗MalfunctionSep 10, 2026Over-Sensing
It was reported that one day after implant, 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 50716048 ↗MalfunctionSep 9, 2026High impedance; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702143 ↗MalfunctionSep 4, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600376 ↗InjurySep 3, 2026Failure to Capture; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; High Capture Threshold
It was reported that the day following implant, the Right Ventricular (RV) lead and Left Ventricular (LV) lead exhibited high thresholds and no capture. The leads had dislodged. The patient experienced bradycardia and unstable Ventricular Tachycardia (VT). It was noted that after the leads lost capture, the patient went into VT and was shocked and this was thought to have been caused by the leads causing a short long pattern. Both leads were explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Bradycardia; Shock from Patient Lead(s); Tachycardia
MAUDE report 50594966 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted and replaced. The reason for explant was not reported. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532729 ↗MalfunctionAug 31, 2026Low impedance; Impedance Problem
It was reported that the Right Ventricular (RV) lead, placed in the Left Bundle Branch (LBB), exhibited decreasing and low defibrillation impedance one day after implant. 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 50519511 ↗MalfunctionAug 28, 2026Over-Sensing
Patient problems: Bradycardia
MAUDE report 50506009 ↗MalfunctionAug 21, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50368121 ↗MalfunctionAug 21, 2026Over-Sensing
It was reported that the Left Bundle Branch Area Pacing (LBBAP) lead exhibited oversensing. 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 50367209 ↗InjuryAug 19, 2026Device Dislodged or Dislocated; High Capture Threshold
It was reported that the Right Ventricular (RV) lead that was placed Left Bundle Branch Area and the Right Atrial (RA) lead had both dislodged as the patient twiddled the leads out of right atrium and right ventricle. The patient also experience an inappropriate shock, palpitations and twiddlers syndrome. The patient was hospitalized and the leads were explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Palpitations; Shock from Patient Lead(s); Twiddlers Syndrome
MAUDE report 50329319 ↗InjuryAug 18, 2026Over-Sensing
It was reported that the patient experienced shortness of breath. It was also reported that the right ventricular-septum placed Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) post ventricular pace. The RV lead was re-positioned and the lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Dyspnea
MAUDE report 50303377 ↗InjuryAug 17, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead experienced crosstalk and oversensing of P-waves. Reprogramming was performed, and the issue was resolved. 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 50274789 ↗InjuryAug 14, 2026Over-Sensing
It was reported that the Left Bundle Branch Area Pacing (LBBAP) lead exhibited T-Wave Oversensing (TWOS) post ventricular pace (VP). Several programming options were tried but the TWOS persisted. 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 50253129 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
It was reported that the lead was not implanted due to patient anatomy and 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 50223640 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201581 ↗MalfunctionAug 7, 2026Break
It was reported that the Left Ventricular (LV) lead was explanted and replaced for unknown reasons. During the procedure, a Right Ventricular (RV) lead implant was attempted. When the RV lead was removed to clean out any tissues after attempting implant, it was noted that the distal end of the RV lead was kinked. The RV lead was not used and another lead was implanted. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50178936 ↗
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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