SelectSecure™ MRI SureScan™ 383069 (UDI 00763000130800)Recalls & reported problems
Medtronic, Inc. · LEAD 383069 MRI US · Class 3 · Implant
Quick summary
This Medtronic SelectSecure MRI is a pacemaker electrode lead placed in the heart. Reports most often describe the lead needing too much power to pace the heart, and some describe leads moving out of place or infections. The device appears in 4,829 reports, including 56 deaths and 3,070 injuries. 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
- 4,850
- Deaths reported
- 56
- Injuries reported
- 3,069
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,850 adverse event reports that list this exact device (DI 00763000130800), received between Dec 26, 2018 and Sep 30, 2026 — classified as 56 deaths, 3,069 injuries, 1,725 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (1,522 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- High Capture Threshold1,522
- Failure to Capture729
- Device Dislodged or Dislocated725
- Adverse Event Without Identified Device or Use Problem709
- Over-Sensing584
- Under-Sensing575
- Capturing Problem504
- Decreased Sensitivity243
Patient problems
- No Clinical Signs, Symptoms or Conditions2,770
- No Known Impact Or Consequence To Patient469
- Unspecified Infection467
- No Consequences Or Impact To Patient207
- Bradycardia151
- Dizziness132
- Dyspnea107
- Syncope/Fainting90
Recent adverse event reports
The 25 most recent of 4,850 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Decreased Sensitivity; Capturing Problem; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high and rising thresholds as well as diminished sensimg. It was further reported that the Right Atrial (RA) lead exhibited decreased pacing. Both leads remain in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944794 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Ventricular (RV) Left Bundle Branch (LBB) lead exhibited T-Wave Oversensing (TWOS). The RV LBB 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 50943191 ↗MalfunctionSep 29, 2026Failure to Capture; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937171 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Discomfort; Unspecified Infection
MAUDE report 50933800 ↗MalfunctionSep 29, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932374 ↗MalfunctionSep 28, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926349 ↗InjurySep 28, 2026Under-Sensing; Low impedance; Impedance Problem
It was reported that the Right Atrial (RA) lead exhibited low impedance. 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 50912842 ↗MalfunctionSep 24, 2026High Capture Threshold
It was reported that there was a failed Atrial Lead Position Check on the Right Atrial (RA) lead and high thresholds on the Right Ventricular (RV) lead. The RV and RA 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 50884052 ↗InjurySep 24, 2026High impedance
It was reported that the His bundle branch Right Ventricular (RV-His) lead exhibited high out of range impedance warnings. 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 50883576 ↗MalfunctionSep 24, 2026Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited undersensing. 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 50880140 ↗InjurySep 23, 2026High Capture Threshold
It was reported that the Left Bundle Branch (LBB) Right Ventricular (RV) lead exhibited high thresholds. The lead was removed and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869739 ↗InjurySep 18, 2026High impedance; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high thresholds and high impedance. The 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 50815933 ↗MalfunctionSep 17, 2026Break
It was reported that the Right Ventricular (RV) lead returned for analysis 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 50802761 ↗MalfunctionSep 17, 2026Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited under sensing. 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 50800795 ↗MalfunctionSep 16, 2026Low impedance
It was reported that the Left Ventricular (LV) lead exhibited low impedance. 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 50788138 ↗MalfunctionSep 15, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) on the current electrograms (EGM). 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 50770591 ↗MalfunctionSep 15, 2026Over-Sensing
It was reported that the patient experienced bradycardia due to T-Wave Oversensing (TWOS) that is occurring on the current electrograms (EGM). A polarity switch and high and undefined impedance warnings were also noted on the Right Atrial (RA) lead. The Right Ventricular Left Bundle Branch (RV-LBB) lead and RA lead remain in use. No further patient complications have been reported as a result of this event.
Patient problems: Bradycardia
MAUDE report 50770542 ↗MalfunctionSep 15, 2026Break
It was reported that the Right Ventricular (RV) lead returned for analysis 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 50769653 ↗InjurySep 15, 2026High Capture Threshold
It was reported that the Right Ventricular (RV) left bundle branch lead exhibited high thresholds leading to premature battery depletion of the Implantable Pulse Generator (IPG). The lead was capped and replaced and the device 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 50769169 ↗MalfunctionSep 14, 2026High impedance; Capturing Problem; Impedance Problem; High Capture Threshold
It was reported that the left bundle branch (LBB) lead exhibited rising thresholds, increasing impedance and high impedance and high thresholds. 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 50752346 ↗InjurySep 11, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the pacing lead exhibited an unknown performance issue and was not functioning within normal tolerances. The pacing 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 50730731 ↗MalfunctionSep 10, 2026Failure to Capture; Pacing Problem; Under-Sensing
It was reported that the patient attended the emergency room as they experienced shortness of breath. Upon device assessment it was noted that the HIS BUNDLE Right Ventricular (RV) lead exhibited under sensing, resulting in over pacing. Loss of capture was noted. The HIS BUNDLE RV lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Dyspnea; No Clinical Signs, Symptoms or Conditions
MAUDE report 50709652 ↗MalfunctionSep 9, 2026Device Sensing Problem
It was reported that the Implantable Pulse Generator (IPG) exhibited abnormal sensing. The IPG 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 50688444 ↗MalfunctionSep 8, 2026Intermittent Capture
Patient problems: Palpitations
MAUDE report 50677354 ↗MalfunctionSep 8, 2026Over-Sensing; Capturing Problem
It was reported that the Right Ventricular (RV) ¿ HIS bundle lead exhibited an increase in short V-V intervals on the Sensing Integrity Counter (SIC) and higher thresholds were noted. The RV-HIS 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 50663943 ↗
Other permanent pacemaker Electrode devices
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · permanent pacemaker Electrode136 deaths16,004 reports
- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode124 deaths8,405 reports
- Capsurefix® Novus 5076-45Medtronic, Inc. · permanent pacemaker Electrode85 deaths7,050 reports
- CapSureFix Novus MRI™ SureScan™ 407652Medtronic, Inc. · permanent pacemaker Electrode69 deaths6,097 reports
- Sprint Quattro Secure® 694765Medtronic, Inc. · permanent pacemaker Electrode73 deaths3,852 reports
- Attain Performa™ MRI SureScan™ 429888Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,377 reports
- CapSureFix Novus MRI™ SureScan™ 407645Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,370 reports
- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode40 deaths3,015 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.