CapSureFix Novus MRI™ SureScan® 5076-52 (UDI 00643169550766)Recalls & reported problems
Medtronic, Inc. · LEAD 5076-52 MRI US · 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 appears in 8,236 adverse event reports, including 79 deaths and 3,651 injuries. The reports mostly describe the lead sensing noise or false signals, high pacing thresholds, and leads shifting out of place, and some mention infections around the implant. 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
- 8,280
- Deaths reported
- 80
- Injuries reported
- 3,660
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8,280 adverse event reports that list this exact device (DI 00643169550766), received between Aug 9, 2016 and Sep 30, 2026 — classified as 80 deaths, 3,660 injuries, 4,540 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (2,835 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-Sensing2,835
- Over-Sensing1,801
- High Capture Threshold1,209
- Adverse Event Without Identified Device or Use Problem1,093
- Device Dislodged or Dislocated793
- Failure to Capture602
- High impedance587
- Pacing Problem541
Patient problems
- No Clinical Signs, Symptoms or Conditions3,576
- No Known Impact Or Consequence To Patient2,429
- Unspecified Infection691
- No Consequences Or Impact To Patient239
- Dizziness177
- Chest Pain170
- Dyspnea141
- Cardiac Perforation126
Recent adverse event reports
The 25 most recent of 8,280 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited oversensing and a mirrored artifact possibly due to an insulation breach on the Right Ventricular (RV) lead. This resulted in frequent mode switching to DDIR. 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 50946607 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited frequent Far Field R-Wave (FFRW) oversensingwhich was increasing the patient's atrial burden. 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 50943384 ↗MalfunctionSep 30, 2026Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing undersensing during Atrial Tachycardia/ Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) 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 50942845 ↗MalfunctionSep 29, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938089 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936928 ↗MalfunctionSep 29, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering false 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 50936612 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50935768 ↗MalfunctionSep 29, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934213 ↗MalfunctionSep 29, 2026Under-Sensing
It was reported that the Implantable Pulse Generator (IPG) reached its End of Service (EOS). The Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected events in progress. The lead and IPG 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 50930812 ↗MalfunctionSep 28, 2026Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited intermittent undersensing. The RV lead remains in use. No patient com plications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912153 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection; Sepsis
MAUDE report 50903137 ↗MalfunctionSep 25, 2026Signal Artifact/Noise; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902900 ↗MalfunctionSep 25, 2026High Capture Threshold
It was reported that 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 50895059 ↗MalfunctionSep 25, 2026Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited under sensing tiggering device classified false termination of Atrial Tachycardia (AT)/Atrial Fibrillation (AF) event(s) at times. 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 50894329 ↗MalfunctionSep 24, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891978 ↗MalfunctionSep 23, 2026Positioning Problem
It was reported by the patient that their pacing leads migrated from behind the Implantable Pulse Generator (IPG) up to their clavicle. 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 50872373 ↗MalfunctionSep 23, 2026High impedance
It was reported that the Right Atrial (RA) lead exhibited high 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 50869625 ↗MalfunctionSep 23, 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 events 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 50867645 ↗MalfunctionSep 18, 2026Under-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 50815889 ↗MalfunctionSep 17, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. 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 50803300 ↗DeathSep 17, 2026High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited high thresholds. The patient later presented with chest pain. Approximately five days later, the patient expired. Additional information related to the cause of death was requested and not received.
Patient problems: Chest Pain
MAUDE report 50801328 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported by the patient that they had an infection and their 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 50790341 ↗MalfunctionSep 16, 2026High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high thresholds leading to battery depletion of the Implantable Pulse Generator (IPG). The lead and IPG 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 50787853 ↗MalfunctionSep 16, 2026Under-Sensing
It was reported that undersensing on the Right Atrial (RA) lead resulted in misclassification of possible Supra Ventricular Tachycardia (SVT) as monitored Ventricular Tachycardia (VT). 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 50785015 ↗InjurySep 14, 2026Signal Artifact/Noise
It was reported that the Right Atrial (RA) lead exhibited noise. 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 50752496 ↗
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
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page