CapSureFix MRI™ SureScan™ 5086MRI58Recalls & reported problems
Medtronic, Inc. · LEAD 5086MRI58 US MARKET EN · Class 3 · Implant
All models of CapSureFix MRI SureScan (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic CapSureFix MRI SureScan lead is a wire that links an implanted heart device to the heart. Many of its 1,190 reports describe the lead misreading heart signals or showing high electrical thresholds and impedance problems. Reports also mention infection, dizziness and slow heart rate, and some describe the lead or generator being replaced. The reports include 9 deaths, 690 injuries and 491 malfunctions. 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
- 1,196
- Deaths reported
- 9
- Injuries reported
- 691
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,196 adverse event reports that list this exact device (DI 00613994657374), received between Dec 10, 2013 and Sep 28, 2026 — classified as 9 deaths, 691 injuries, 496 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (258 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-Sensing258
- High Capture Threshold241
- High impedance203
- Under-Sensing193
- Adverse Event Without Identified Device or Use Problem191
- Impedance Problem137
- Signal Artifact/Noise133
- Failure to Capture114
Patient problems
- No Clinical Signs, Symptoms or Conditions558
- No Known Impact Or Consequence To Patient226
- Unspecified Infection138
- No Consequences Or Impact To Patient52
- Dizziness29
- Bradycardia23
- Syncope23
- Chest Pain19
Recent adverse event reports
The 25 most recent of 1,196 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited 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 50913103 ↗MalfunctionSep 17, 2026Pacing Problem; Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. The lead remains in u se. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800499 ↗MalfunctionSep 16, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785851 ↗InjurySep 14, 2026Intermittent Capture; Capturing Problem
It was reported that the Right Ventricular (RV) lead exhibited a rise in thresholds and intermittent loss of capture. The lead was capped and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756039 ↗MalfunctionSep 10, 2026Pacing Problem; Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited under sensing resulting in inappropriate 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 50711909 ↗InjurySep 9, 2026Signal Artifact/Noise
It was reported that both the Right Atrial (RA) lead and the Right Ventricular (RV) lead exhibited noise. Both leads were 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 50689340 ↗MalfunctionSep 4, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50607414 ↗MalfunctionSep 2, 2026Impedance Problem
It was reported that the Right Ventricular (RV) lead exhibited a rise in bipolar impedance. 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 50564933 ↗InjuryAug 28, 2026Extracardiac stimulation
It was reported that the patient experienced pocket stimulation. The Right Ventricular (RV) lead was capped and replaced with a lead less Implantable Pulse Generator (IPG). No further patient complications have been reported as a result of this event.
Patient problems: Device Overstimulation of Tissue; Inappropriate Device Stimulation of Tissue
MAUDE report 50493369 ↗InjuryAug 27, 2026Pacing Problem
It was reported that the Right Ventricular (RV) ¿ Left Bundle Branch (LBB) lead was capped and replaced due to chronic high-burden right ventricular pacing and associated left ventricular dysfunction and associated with atrial fibrillation. No further patient complications have been reported as a result of this event. The patient is a participant in a clinical study.
Patient problems: Cardiomyopathy
MAUDE report 50472008 ↗MalfunctionAug 20, 2026Signal Artifact/Noise; Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited over sensing, resulting in misclassification of episode type. It was reported that the Right Ventricular (RV) lead exhibited over sensing, resulting in misclassification of episode type. Both leads exhibited noise. 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 50341790 ↗MalfunctionAug 19, 2026Unstable Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited variable thresholds and the Implantable Pulse Generator (IPG) exhibited premature battery depletion. The device and lead 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 50318711 ↗MalfunctionAug 10, 2026Signal Artifact/Noise; Over-Sensing; Capturing Problem; Impedance Problem; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high and rising thresholds, noise, a high number of Sensing Integrity Counter (SIC) and triggered an alert for rising 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 50192004 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM AND IT WAS EXPOSED FROM THE SKIN. THE IPG SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Erosion
MAUDE report 25688053 ↗MalfunctionJun 30, 2026Pacing Problem; Under-Sensing
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES. 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 25667281 ↗MalfunctionJun 18, 2026Under-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSED R WAVE DURING NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES. 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 25545437 ↗InjuryJun 16, 2026Signal Artifact/Noise; Fracture
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS HAD A SUSPECTED LOW VOLTAGE FRACTURE AND EXHIBITED NOISE. THE LEADS WERE 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 25523027 ↗MalfunctionMay 28, 2026Over-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING ON STORED EPISODES AND SHORT V-V INTERVALS. 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 25321442 ↗MalfunctionMay 28, 2026High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED 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 25316332 ↗InjuryMay 26, 2026High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25277339 ↗InjuryMay 25, 2026High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS REMOVED AND REPLACED. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270650 ↗MalfunctionMay 22, 2026Under-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING THAT IS RESULTING IN BACKUP 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 25253254 ↗InjuryMay 15, 2026Capturing Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLDS. THE LEAD REMAINS 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 25181758 ↗MalfunctionMay 15, 2026High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 25181229 ↗MalfunctionMay 14, 2026Low impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. 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 25169760 ↗
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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