CapSureFix Novus MRI™ SureScan® 5076-52 (UDI 00643169633759)Recalls & reported problems
Medtronic, Inc. · LEAD 5076-52 RCMCRD 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 is a Medtronic CapSureFix Novus MRI lead, an implanted heart device lead. Its reports mostly describe sensing errors, leads that move out of place, pacing problems and infections, and some mention a perforated heart wall. There are 30,259 reports, including 332 deaths and 14,514 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
- 30,581
- Deaths reported
- 333
- Injuries reported
- 14,579
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30,581 adverse event reports that list this exact device (DI 00643169633759), received between Dec 7, 2017 and Sep 30, 2026 — classified as 333 deaths, 14,579 injuries, 15,668 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (9,956 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-Sensing9,956
- Adverse Event Without Identified Device or Use Problem5,792
- Device Dislodged or Dislocated4,771
- Over-Sensing4,444
- High Capture Threshold3,401
- Pacing Problem2,272
- Failure to Capture2,059
- High impedance1,486
Patient problems
- No Clinical Signs, Symptoms or Conditions17,985
- Unspecified Infection3,554
- No Known Impact Or Consequence To Patient2,993
- No Consequences Or Impact To Patient799
- Chest Pain682
- Cardiac Perforation597
- Pericardial Effusion547
- Dyspnea519
Recent adverse event reports
The 25 most recent of 30,581 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Over-Sensing; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954489 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 50953665 ↗InjurySep 30, 2026Over-Sensing; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951856 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacteremia; Unspecified Infection
MAUDE report 50951241 ↗MalfunctionSep 30, 2026High impedance; Unstable Impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950632 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing; Decreased Sensitivity
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949438 ↗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 termination of AT/AF detected events in progress, unnecessary atrial pacing during AT/AF events, and misclassification of Atrial Fibrillation (AF)-Supra Ventricular Tachycardia (SVT) episode. 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 50948666 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
It was reported that the patient experienced arrhythmia. It was also 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: Arrhythmia
MAUDE report 50947463 ↗MalfunctionSep 30, 2026Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited intermittent undersensing on the atrial lead 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 50947009 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited oversensing resulting in false detection of Atrial Tachycardia/Atrial Fibrillation (AT/AF) 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 50946871 ↗MalfunctionSep 30, 2026Device Sensing Problem
It was reported intraoperatively that the Right Atrial (RA) lead exhibited no signal when connected to the analyzer testing cables. The RA lead was replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946535 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection. The Implantable Pulse Generator (IPG) system was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50946145 ↗InjurySep 30, 2026Signal Artifact/Noise
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946042 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the Right Atrial (RA) lead was removed and replaced 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 50946040 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection and bacteremia. The Implantable Pulse Generator (IPG) system was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Unspecified Infection
MAUDE report 50945792 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead and Right Ventricular (RV) left bundle branch lead exhibited undersensing and unnecessary 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 50945404 ↗MalfunctionSep 30, 2026Failure to Capture; Electrical /Electronic Property Problem
It was reported that there was no capture and a failed Atrial Lead Position Check. 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 50945017 ↗MalfunctionSep 30, 2026Pacing Problem
It was reported that the Right Ventricular (RV) lead exhibited high and rising thresholds as well as diminished sensimg. It was further reported that the Right Atrial (RA) lead exhibited decreased pacing. 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 50944834 ↗MalfunctionSep 30, 2026Under-Sensing
It was reported that the patient experienced a shock from their Implantable Pulse Generator (IPG). It was also reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes resulting in termination of AT/AF detected event(s) in progress. The IPG system 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 50944663 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. The lead remains in use. No patient c omplications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944179 ↗MalfunctionSep 30, 2026Capturing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943977 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
It was reported approximately five months post implant 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 and unnecessary pacing 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 50943517 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
It was reported post-operatviely that the Right Ventricular (RV) lead exhibited undersensing resulting in over-pacing and decreased R waves. 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 50943060 ↗MalfunctionSep 30, 2026High impedance; Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited oversensing and high impedance. The lead remains in use. No patient c omplications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942973 ↗MalfunctionSep 30, 2026Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing on current and stored episodes during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in termination of AT/AF detected events in progress.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942953 ↗
Other Permanent defibrillator electrodes devices
- 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
- 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