Capsurefix® Novus 5076-52Recalls & reported problems
Medtronic, Inc. · LEAD 5076-52 CAPSUREFIX NOVUS US EN · Class 3 · Implant
Quick summary
This Medtronic Capsurefix Novus heart lead appears in 9,819 adverse event reports, including 111 deaths and 5,053 injuries. The reports mostly describe the lead missing heartbeats or sensing false signals, along with rising electrical resistance and noise, and some mention infections around the implant pocket. 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
- 9,860
- Deaths reported
- 111
- Injuries reported
- 5,065
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9,860 adverse event reports that list this exact device (DI 00681490124812), received between Feb 25, 2013 and Sep 30, 2026 — classified as 111 deaths, 5,065 injuries, 4,683 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (2,791 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-Sensing2,791
- Over-Sensing1,705
- Adverse Event Without Identified Device or Use Problem1,657
- High Capture Threshold1,606
- High impedance1,323
- Signal Artifact/Noise883
- Fracture824
- Failure to Capture688
Patient problems
- No Clinical Signs, Symptoms or Conditions4,528
- No Known Impact Or Consequence To Patient2,322
- Unspecified Infection1,107
- No Consequences Or Impact To Patient356
- Dizziness162
- Cardiac Perforation151
- Chest Pain149
- Dyspnea149
Recent adverse event reports
The 25 most recent of 9,860 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Capture; Fracture; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951782 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the patient attended the emergency room as they experienced dizziness and near-syncope. Upon device assessment it was noted that the Right Ventricular (RV) lead was over sensing non-physiologic intervals. The RV lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Dizziness; Presyncope
MAUDE report 50943147 ↗InjurySep 29, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928923 ↗MalfunctionSep 28, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926263 ↗MalfunctionSep 28, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during stored Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes resulting in false termination of the AT/AF events and intermittent inappropriate pacing. 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 50918882 ↗InjurySep 28, 2026Failure to Capture; Fracture; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918150 ↗MalfunctionSep 28, 2026Under-Sensing; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918090 ↗InjurySep 28, 2026Device Dislodged or Dislocated
It was reported that one day post implant, an x-ray confirmed dislodgement of the Right Atrial (RA) lead. 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 50914841 ↗InjurySep 25, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem
It was reported that the Right Atrial (RA) lead had exhibited Out of Range (OOR) high pacing impedance. The lead was then reprogrammed. Then it was noted that the waveform suspected to be noise and Far Field R-Wave (FFRW) oversensing were detected in atrial -side events and the atrial high rate pacing therapy was being delivered in response to those waveforms. The lead was then reprogrammed off. 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 50899160 ↗MalfunctionSep 25, 2026Signal Artifact/Noise; Over-Sensing
It was reported that the patient experienced dizziness and near syncope. The Right Atrial (RA) lead exhibited oversensing resulting in misclassification of episode type, Far Field R-Wave (FFRW) oversensing triggering false Atrial Tachycardia/Atrial Fibrillation ( AT/AF) detections and noise. The lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Dizziness; Presyncope
MAUDE report 50897543 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Purulent Discharge; Swelling/ Edema
MAUDE report 50888772 ↗MalfunctionSep 24, 2026High impedance; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884658 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately one month post replacement procedure, the patient developed a pocket infection. It was noted that the patient developed purulent discharge/pus. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was 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: Unspecified Infection
MAUDE report 50877022 ↗MalfunctionSep 23, 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 termination of AT/AF detected event(s) in progress. Low P waves was noted as well. 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 50866172 ↗MalfunctionSep 23, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited under sensing during Atrial Tachycardia (AT)/Atrial Fibrillation (AF), resulting in unnecessary pacing at times and pre-termination of AT/AF Event in progress. 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 50865501 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fever; Itching Sensation; Medical Device Site Inflammation; Medical device site infection; Pain; Purulent Discharge
MAUDE report 50829899 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Purulent Discharge; Unspecified Infection
MAUDE report 50828508 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) system and absorbable antibacterial envelope were explanted and replaced due pocket infection and wound dehiscence. No further patient complications have been reported as a result of this event.
Patient problems: Medical device site infection; Wound Dehiscence
MAUDE report 50827114 ↗MalfunctionSep 18, 2026Pacing Problem; Under-Sensing
It was reported that the patient presented with chest pain, and upon review it was found that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to increase in Sensing Integrity Counter (SIC) and two or more High Rate-Non Sustained episodes. An RV lead fracture was suspected. The lead exhibited high undefined Superior Vena Cava (SVC) coil impedance, varying pacing impedance, oversensing resulting in inhibition of pacing, noise, and high capture thresholds. All high voltage therapies were programmed off. It was also 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, with inappropriate atrial pacing note at times. The leads remain 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 50819570 ↗InjurySep 18, 2026Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited under-sensing. A low amplitude tachycardia waveform was noted. The lead was reprogrammed 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 50816210 ↗MalfunctionSep 18, 2026Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited undersensing. 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 50814685 ↗InjurySep 17, 2026Capturing Problem
It was reported that the Right Ventricular (RV) lead exhibited increase in thresholds. Initially, the lead was programmed off, later a Leadless implantable pulse generator (IPG) was added. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802332 ↗MalfunctionSep 17, 2026Over-Sensing; Under-Sensing; Decreased Sensitivity
It was reported that the Right Atrial (RA) lead had exhibited stored episodes for intermittent undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events and Far Field R-Wave (FFRW) oversensing at times. It was noted that the RA Lead had a low amplitude. 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 50797633 ↗InjurySep 16, 2026Fracture
It was reported that the Right Ventricular (RV) lead exhibited a fracture. 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 50790697 ↗MalfunctionSep 16, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation stored episodes resulting in termination of detected events 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 50787946 ↗
Other Permanent defibrillator electrodes devices
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- 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
- 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.