SelectSecure MRI SureScanRecalls & reported problems across all models
Medtronic, Inc. · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12,688
- Deaths reported
- 139
- Injuries reported
- 7,892
- Recalls
- 0
We found 9 models of SelectSecure MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 12,688 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2017 and Sep 30, 2026 — classified as 139 deaths, 7,892 injuries, 4,657 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (3,328 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 SelectSecure MRI SureScan problems
Device problems
- High Capture Threshold3,328
- Device Dislodged or Dislocated2,246
- Adverse Event Without Identified Device or Use Problem2,149
- Under-Sensing1,685
- Failure to Capture1,668
- Over-Sensing1,419
- Capturing Problem1,132
- Pacing Problem678
Patient problems
- No Clinical Signs, Symptoms or Conditions7,392
- Unspecified Infection1,287
- No Known Impact Or Consequence To Patient1,245
- Bradycardia400
- Dizziness307
- No Consequences Or Impact To Patient283
- Erythema243
- Dyspnea225
SelectSecure MRI SureScan models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SelectSecure™ MRI SureScan™ 383069Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes50 deaths5,027 reports
- SelectSecure™ MRI SureScan™ 383069permanent pacemaker Electrode56 deaths4,850 reports
- SelectSecure™ MRI SureScan™ 383069permanent pacemaker Electrode9 deaths1,516 reports
- SelectSecure™ MRI SureScan™ 383059Permanent defibrillator electrodes18 deaths574 reports
- SelectSecure™ MRI SureScan™ 383059Permanent defibrillator electrodes3 deaths450 reports
- SelectSecure™ MRI SureScan™ 383059permanent pacemaker Electrode133 reports
- SelectSecure™ MRI SureScan™ 383074Permanent defibrillator electrodes56 reports
- SelectSecure™ MRI SureScan™ 383074permanent pacemaker Electrode1 death51 reports
- SelectSecure™ MRI SureScan™ 383074permanent pacemaker Electrode2 deaths31 reports
Recent SelectSecure 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, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948411 ↗InjurySep 30, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947987 ↗InjurySep 30, 2026Capturing Problem; High Capture Threshold
It was reported that the Right Ventricular Left Bundle Branch (RV-LBB) lead exhibited high thresholds and rising thresholds. The lead was reprogrammed and later 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 50947358 ↗MalfunctionSep 30, 2026Positioning Problem
It was reported that intra-operatively two pacing leads had tissue built up in the helix. Both leads were not used and were replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947221 ↗MalfunctionSep 30, 2026Positioning Problem
It was reported that intra-operatively two pacing leads had tissue built up in the helix. Both leads were not used and were replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947203 ↗InjurySep 30, 2026Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold
It was reported that seven weeks post implant the Right Atrial (RA) lead and Right Ventricular (RV) Left Bundle Branch (LBB) lead dislodged. The RV LBB lead exhibited high thresholds and intermittent capture. The RA lead exhibited no capture and no sensing. The physician was suspicious of Twiddler's Syndrome due to the lack of slack and possible twists in the leads seen on x-ray. Upon opening the pocket, knots were seen in the lead coils, indicating the dislodgement was due to Twiddlers' Syndrome. The RV LBB lead was reprogrammed. The RA lead and RV LBB leads were explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Twiddlers Syndrome
MAUDE report 50946253 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection. The Implantable Pulse Generator (IPG) system was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50945982 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead and Right Ventricular (RV) left bundle branch lead exhibited undersensing and unnecessary pacing. The 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 50945392 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Ventricular (RV) HIS Bundle lead exhibited cross chamber 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 50945252 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the patient experienced a low heart rate. It was also 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: Bradycardia
MAUDE report 50945068 ↗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 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a medical device site infection, discomfort, purulent discharge and bacteremia. The Imp lantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Drug Resistant Bacterial Infection; Medical device site infection; Purulent Discharge
MAUDE report 50944306 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a medical device site infection, discomfort, purulent discharge and bacteremia. The Imp lantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Drug Resistant Bacterial Infection; Medical device site infection; Purulent Discharge
MAUDE report 50944300 ↗MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing
It was reported that the patient was hospitalized. It was further reported that the Right Ventricular (RV) lead exhibited oversensing and noise. 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 50944296 ↗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 ↗
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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