Capsurefix® Novus 5076-45Recalls & reported problems
Medtronic, Inc. · LEAD 5076-45 CAPSUREFIX NOVUS US EN · Class 3 · Implant
Quick summary
This Medtronic Capsurefix Novus pacing lead is placed inside the heart. Reports mostly describe the lead missing or falsely sensing heartbeats, noise, high electrical resistance, and fractures. There are 7,019 reports, including 85 deaths and 2,956 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
- 7,050
- Deaths reported
- 85
- Injuries reported
- 2,962
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7,050 adverse event reports that list this exact device (DI 00681490124799), received between Jun 9, 2015 and Sep 30, 2026 — classified as 85 deaths, 2,962 injuries, 4,003 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (2,726 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
- Under-Sensing2,726
- Over-Sensing1,419
- Adverse Event Without Identified Device or Use Problem953
- High Capture Threshold816
- High impedance660
- Signal Artifact/Noise641
- Pacing Problem467
- Fracture447
Patient problems
- No Clinical Signs, Symptoms or Conditions3,494
- No Known Impact Or Consequence To Patient1,766
- Unspecified Infection666
- No Consequences Or Impact To Patient298
- Chest Pain92
- Dyspnea88
- Dizziness85
- Pericardial Effusion77
Recent adverse event reports
The 25 most recent of 7,050 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Signal Artifact/Noise; Impedance Problem
It was reported that the Right Atrial (RA) lead exhibited noise and a change in 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 50946794 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited oversensing on stored 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 50944008 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in appropriate atrial pacing and 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 50942997 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the emergency department due to pain at the pocket site. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) device system was explanted due to a pocket infection. No further patient complications have been reported as a result of this event.
Patient problems: Medical device site infection; Pain
MAUDE report 50932758 ↗InjurySep 29, 2026Signal Artifact/Noise; Electrical /Electronic Property Problem; High impedance
It was reported that the Right Atrial (RA) lead exhibited high impedance, noise and failed a lead position check. The RA lead was re programmed 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 50929434 ↗MalfunctionSep 29, 2026Electrical /Electronic Property Problem; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929413 ↗MalfunctionSep 29, 2026Over-Sensing; Under-Sensing
It was reported that that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing and under sensing. 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 50928838 ↗MalfunctionSep 25, 2026Low impedance; Impedance Problem
It was further reported that the RA lead impedance alert was for low impedance which since returned to within normal range and it did not occur during a procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898496 ↗MalfunctionSep 25, 2026Pacing Problem; Under-Sensing; High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited under sensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times. It was also reported that the RA displayed high thresholds. 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 50896466 ↗MalfunctionSep 24, 2026High impedance; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885994 ↗MalfunctionSep 24, 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 50884019 ↗MalfunctionSep 23, 2026Signal Artifact/Noise; Failure to Capture; Over-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, loss of capture, oversesning and noise. The Right Ventricular (RV) lead exhibited oversensing and noise. 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 50866961 ↗MalfunctionSep 18, 2026Electrical /Electronic Property Problem; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827586 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Purulent Discharge; Unspecified Infection
MAUDE report 50827188 ↗MalfunctionSep 18, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in termination of AT/AF detected events in progress and 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 50819999 ↗MalfunctionSep 18, 2026High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited high thresholds. The RA lead remains in use. It was noted on stored episodes that atrial events falling in the blanking period resulted in unnecessary pacing at times. The Implantable Pulse Generator (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 50816729 ↗MalfunctionSep 18, 2026Low impedance
It was reported that the Right Atrial (RA) lead exhibited an alert warning for low impedance. 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 50815838 ↗MalfunctionSep 17, 2026Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events. 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 50801771 ↗InjurySep 15, 2026Over-Sensing
It was reported that the patient experienced a fall or possible syncope. The Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering false Atrial Tachycardia/Atrial Fibrillation (AT/AF) detections. The RA lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Fall; Syncope/Fainting
MAUDE report 50772086 ↗MalfunctionSep 14, 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, and resulting in termination of AT/AF detected event(s) in progress. The patient experienced lethargy. The RA lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Fatigue
MAUDE report 50755249 ↗MalfunctionSep 14, 2026Low impedance
It was reported that the patient experienced chest pain. It was also reported that the Right Atrial (RA) lead exhibited low impedance. The RA lead 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 50753163 ↗InjurySep 14, 2026Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available
It was reported that the Right Atrial (RA) lead was capped and replaced for unknown reasons. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50750246 ↗InjurySep 10, 2026Signal Artifact/Noise; High impedance; Device Contamination with Body Fluid; Connection Problem; Device Dislodged or Dislocated; High Capture Threshold
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 50721482 ↗MalfunctionSep 10, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720081 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced due to an infection with Endocarditis. No further patient complications have been reported as a result of this event.
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 50717096 ↗
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 MRI™ SureScan™ 407652Medtronic, Inc. · permanent pacemaker Electrode69 deaths6,097 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · permanent pacemaker Electrode56 deaths4,850 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.