Capsurefix® Novus 5076-58Recalls & reported problems
Medtronic, Inc. · LEAD 5076-58 CAPSUREFIX NOVUS US EN · Class 3 · Implant
Quick summary
This Medtronic Capsurefix Novus lead is an implanted lead that connects a heart device to the heart. Its 4,568 adverse event reports mostly describe high electrical thresholds, high impedance, oversensing and fractured or breached leads, and some describe cardiac perforation and infection, with leads removed and replaced in several cases. The reports include 47 deaths and 3,066 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
- 4,587
- Deaths reported
- 47
- Injuries reported
- 3,079
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,587 adverse event reports that list this exact device (DI 00681490124867), received between Aug 10, 2013 and Sep 30, 2026 — classified as 47 deaths, 3,079 injuries, 1,461 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (1,284 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 Threshold1,284
- High impedance1,043
- Over-Sensing779
- Adverse Event Without Identified Device or Use Problem755
- Fracture702
- Impedance Problem530
- Failure to Capture524
- Signal Artifact/Noise514
Patient problems
- No Clinical Signs, Symptoms or Conditions1,850
- No Known Impact Or Consequence To Patient1,066
- Unspecified Infection514
- No Consequences Or Impact To Patient196
- Bradycardia155
- Dizziness152
- Syncope/Fainting106
- Syncope88
Recent adverse event reports
The 25 most recent of 4,587 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 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 50943950 ↗InjurySep 29, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930259 ↗MalfunctionSep 29, 2026Signal Artifact/Noise; Electrical /Electronic Property Problem; High impedance; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928970 ↗InjurySep 29, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928921 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50928880 ↗MalfunctionSep 26, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908402 ↗InjurySep 23, 2026Capturing Problem; Device Dislodged or Dislocated
It was reported that on the pre-discharge device check post Implantable Pulse Generator (IPG) implant, the R waves had decreased and thresholds had increased since implant. A chest X-ray confirmed that the Implantable Pulse Generator (IPG) had moved downwards and the Right Ventricular (RV) lead dislodged as a result. The IPG and RV lead were repositioned and remain in use. It was considered that the cause was likely weak tissue in the pocket area. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866339 ↗InjurySep 16, 2026Capturing Problem
It was reported that the Right Atrial (RA) lead exhibited high and rising thresholds. It was further reported that the Right Ventricular (RV) lead exhibited rising thresholds. 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 50785831 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an infection. The Right Atrial (RA) and Right Ventricular (RV) leads were explanted. The RV lead was replaced. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50771740 ↗MalfunctionSep 11, 2026Signal Artifact/Noise; Over-Sensing; Low impedance; High Capture Threshold; Unstable Impedance
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 50735222 ↗InjurySep 10, 2026Capturing Problem; Impedance Problem; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited rising and high thresholds as well as rising 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 50714288 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed a pocket infection. The leads and competitor Implantable Pulse Generator (IPG) were explanted and replaced with a Leadless implantable pulse generator (IPG). No further patient complications have been reported as a result of this event.
Patient problems: Medical device site infection
MAUDE report 50689025 ↗MalfunctionSep 8, 2026High impedance; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high thresholds and elevated lead 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 50668704 ↗InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the Implantable Pulse Generator (IPG) system was removed for an unknown reason. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50666138 ↗InjurySep 4, 2026High Capture Threshold
It was reported that the patient experienced muscle stimulation. The Right Ventricular (RV) lead exhibited high thresholds. The lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50606601 ↗InjurySep 2, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572823 ↗MalfunctionSep 1, 2026Pacing Problem; Under-Sensing
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, misclassification of episodes and termination of AT/AF detected event(s) in progress. It was also reported that the Right Ventricular (RV) lead exhibited under sensing. Both, the RA and 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 50539988 ↗MalfunctionSep 1, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50537898 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced palpitations, chest discomfort and a cardiac perforation from the Right Ventricular (RV) lead approximately eleven days post implant. The lead was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Cardiac Perforation; Discomfort; Palpitations
MAUDE report 50525527 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an infection. Staphylococcus aureus noted. The Implantable Pulse Generator (IPG) system was explanted and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Bacterial Infection
MAUDE report 50494570 ↗MalfunctionAug 28, 2026Failure to Capture; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50493935 ↗InjuryAug 27, 2026Break; Over-Sensing
It was reported that the Right Atrial (RA) lead and the Right Ventricular (RV) lead exhibited insulation breach and oversensing. The 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 50473165 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection with noted vegetation. A leadless Implantable Pulse Generator (IPG) was implanted. No further patient complications have been reported as a result of this event.
Patient problems: Medical device site infection
MAUDE report 50439797 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced six days later. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50414164 ↗InjuryAug 23, 2026Break; Failure to Capture
It was reported that the Right Ventricular (RV) lead exhibited an insulation breach leading to 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 50397273 ↗
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
- ENDOTAK RELIANCE® SG 0292Boston Scientific Corporation · Permanent defibrillator electrodes16 deaths3,197 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.