CapSureFix Novus MRI™ SureScan® 5076-45 (UDI 00643169448889)Recalls & reported problems
Medtronic, Inc. · LEAD 5076-45 MRI US EIFU · Class 3 · Implant
All models of CapSureFix Novus MRI SureScan (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic CapSureFix Novus MRI heart lead has 1,236 adverse event reports, including 9 deaths and 444 injuries. Many reports describe the lead failing to detect heartbeats correctly or sensing signals that are not there, and some describe infection and erosion around the device, or the lead shifting out of position. 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
- 1,251
- Deaths reported
- 9
- Injuries reported
- 447
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,251 adverse event reports that list this exact device (DI 00643169448889), received between Jun 10, 2015 and Sep 28, 2026 — classified as 9 deaths, 447 injuries, 795 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (639 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
- Under-Sensing639
- Over-Sensing256
- Adverse Event Without Identified Device or Use Problem141
- Pacing Problem97
- High Capture Threshold94
- Signal Artifact/Noise90
- High impedance88
- Decreased Sensitivity62
Patient problems
- No Clinical Signs, Symptoms or Conditions676
- No Known Impact Or Consequence To Patient301
- Unspecified Infection108
- No Consequences Or Impact To Patient43
- Dizziness19
- Chest Pain16
- Bradycardia13
- Endocarditis13
Recent adverse event reports
The 25 most recent of 1,251 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. Low P waves were noted. It was further reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate 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 50911600 ↗MalfunctionSep 25, 2026Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) in progress. 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 50895597 ↗MalfunctionSep 24, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing resulting in inappropriate pacing. It was also reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate 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 50882501 ↗InjurySep 23, 2026Under-Sensing
It was reported that both the Right Atrial (RA) and Right Ventricular (RV) lead exhibited undersensing. Both lead sensitivity and polarity were reprogramed 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 50869288 ↗MalfunctionSep 22, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859739 ↗MalfunctionSep 18, 2026Pacing Problem; Under-Sensing
It was reported that the patient experienced spasms around the Implantable Pulse Generator (IPG). The Right Ventricular (RV) lead exhibited undersensing and the Right Atrial (RA) lead exhibited undersensing resulting in overpacing. The IPG system 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 50815892 ↗MalfunctionSep 16, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering false Atrial Tachycardia/Atrial Fibrillation (AT/AF) detections. 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 50788154 ↗InjurySep 16, 2026Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF). The lead was reprogrammed off and then nine months later, 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 50785411 ↗MalfunctionSep 15, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited oversensing triggering episode misclassification at times. The RA lead remains in use. It was also reported that the Right Ventricular (RV) lead exhibited intermittent T-wave oversensing. 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 50768156 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50740540 ↗MalfunctionSep 6, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50638152 ↗MalfunctionSep 2, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50560821 ↗MalfunctionSep 2, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50559085 ↗MalfunctionSep 2, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558395 ↗MalfunctionAug 31, 2026Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem
It was reported that the Right Atrial (RA) lead exhibited oversensing resulting in inhibition of pacing and misclassification of episode type along with noise and Far Field R-Wave (FFRW) oversensing. High out of range impedance unipolar and bipolar warnings along with loss of capture were noted. The 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 50515974 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an infection and erosion. The Implantable Pulse Generator (IPG) system was explanted and a temporary Right Ventricular (RV) lead was added and the existing IPG was used for external temporary pacing. No further patient complications have been reported as a result of this event.
Patient problems: Erosion; Unspecified Infection
MAUDE report 50425631 ↗MalfunctionAug 21, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50373013 ↗InjuryAug 12, 2026Low impedance
It was reported that the Right Atrial (RA) lead exhibited Out of Range (OOR) 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 50222731 ↗MalfunctionAug 12, 2026Decreased Sensitivity
It was reported that the Right Atrial (RA) lead exhibited diminished sensing with an "abrupt drop from base line on P wave amplitude" noted. The 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 50220427 ↗MalfunctionAug 12, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220025 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately two weeks post Implantable Pulse Generator (IPG) replacement the patient experienced a pocket infection, pocket erosion, purulent discharge, and bacteremia. The IPG system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Medical device site infection; Pocket Erosion; Purulent Discharge
MAUDE report 50155823 ↗InjuryAug 3, 2026High impedance
It was reported that the Right Atrial (RA) lead exhibited high impedance. 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 50120771 ↗InjuryJul 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to Sensing Integrity Counter (SIC) and High Rate Non-Sustained episodes. In addition both the RV and Right Atrial (RA) lead exhibited noise and oversensing. The patient received an inappropriate shock due to the noise and oversensing. It was also noted that the patient was in a swimming pool at the time of the LIA. The RV and RA leads remain in use. No further patient complications have been reported as a result of this event.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50077689 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed pocket infection. Patient experienced discomfort, fever, purulent discharge/pus, redness, swelling. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50074318 ↗MalfunctionJul 29, 2026Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50066732 ↗
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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