CapSureFix Novus MRI™ SureScan® 5076-45 (UDI 00643169550759)Recalls & reported problems
Medtronic, Inc. · LEAD 5076-45 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 is a pacemaker electrode lead placed in the heart. Reports most often describe the lead misreading heart signals, sensing too little or too much, and moving out of place. Some reports describe infections and removal of the leads. The device appears in 4,978 reports, including 40 deaths and 1,762 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
- 5,000
- Deaths reported
- 40
- Injuries reported
- 1,762
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5,000 adverse event reports that list this exact device (DI 00643169550759), received between Feb 9, 2016 and Sep 30, 2026 — classified as 40 deaths, 1,762 injuries, 3,198 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (2,335 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-Sensing2,335
- Over-Sensing1,068
- Adverse Event Without Identified Device or Use Problem514
- High Capture Threshold491
- Device Dislodged or Dislocated486
- Pacing Problem372
- Failure to Capture248
- Decreased Sensitivity246
Patient problems
- No Clinical Signs, Symptoms or Conditions2,385
- No Known Impact Or Consequence To Patient1,479
- Unspecified Infection360
- No Consequences Or Impact To Patient158
- Dyspnea89
- Chest Pain85
- Dizziness67
- Bradycardia44
Recent adverse event reports
The 25 most recent of 5,000 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
Patient problems: Dyspnea
MAUDE report 50950832 ↗MalfunctionSep 30, 2026Break
It was reported that the Right Atrial (RA) lead returned for analysis and tested out-of-specification. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943164 ↗MalfunctionSep 29, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering AT/AF episode misclassification. It was also reported that the Right Ventricular (RV) lead exhibited undersensing leading to overpacing on Atrial Tachycardia/A trial Fibrillation (AT/AF) episodes, oversensing on the ventricular lead resulting in misclassification of episode type and high thresholds. The RA lead and RV lead 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 50929879 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50917601 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient reported discomfort/pain and the Implantable Cardioverter Defibrillator (ICD) device system was explanted due to an infection. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 50916230 ↗MalfunctionSep 28, 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 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 50912681 ↗MalfunctionSep 25, 2026Pacing Problem; Under-Sensing
It was reported that the patient experienced chest pain. It was also Right Atrial (RA) lead exhibited undersensing resulting in unnecessary atrial pacing at times. The RA lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Chest Pain
MAUDE report 50895061 ↗MalfunctionSep 25, 2026Under-Sensing; Low impedance
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. It also reported 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 50894966 ↗MalfunctionSep 18, 2026Pacing Problem; Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited low pacing impedance. It was also reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in failure to detect AT/AF episodes in progress and in termination of AT/AF detected event(s) in progress, as well as in unnecessary pacing at times. 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 50820433 ↗MalfunctionSep 18, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited under sensing on Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes, resulting in termination of AT/AF detected event(s) in progress and unnecessary atrial pacing. The RA lead also exhibited intermittent under sensing on stored Ventricular Tachycardia (VT) episodes, resulting in misclassification of 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 50818287 ↗MalfunctionSep 18, 2026Pacing Problem; Under-Sensing
It was reported that the patient experienced shortness of breath and the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times and termination of AT/AF detected events. It was also noted that there were low P-waves. The lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: Dyspnea
MAUDE report 50818184 ↗MalfunctionSep 17, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) which resulted in inappropriate atrial pacing. The patient experienced dizziness. The RA lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: Dizziness
MAUDE report 50805261 ↗MalfunctionSep 16, 2026Signal Artifact/Noise; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792393 ↗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 50790297 ↗MalfunctionSep 16, 2026Signal Artifact/Noise; Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited oversensing resulting in misclassification of episode type. Noise was noted. 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 50785938 ↗MalfunctionSep 16, 2026Electrical /Electronic Property Problem; Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing and failed position check. It was further reported that the Right Ventricular (RV) lead exhibited high thresholds. The leads 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 50784507 ↗MalfunctionSep 15, 2026Under-Sensing
It was reported that Right Atrial (RA) lead undersensing resulted in possible Atrial Tachycardia/Atrial Fibrillation (AT/AF) with fast ventricular response being detected as a monitored Non-Sustained Ventricular Tachycardia. 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 50769267 ↗MalfunctionSep 11, 2026Pacing Problem; Under-Sensing; Decreased Sensitivity
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740284 ↗MalfunctionSep 11, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738281 ↗InjurySep 11, 2026Fracture
It was reported that both the Right Atrial (RA) lead and the Right Ventricular (RV) lead were fractured. The Implantable Pulse Generator (IPG) system 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 50728210 ↗MalfunctionSep 10, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715621 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erosion
MAUDE report 50649715 ↗MalfunctionSep 7, 2026Pacing Problem; Under-Sensing
Patient problems: Dyspnea
MAUDE report 50649400 ↗MalfunctionSep 7, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50647168 ↗MalfunctionSep 4, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616609 ↗
Other Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes devices
- Tendril™ STSSt. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes438 deaths19,632 reports
- Tendril™ STSSt. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes200 deaths12,708 reports
- INGEVITY™ MRI 7741Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes36 deaths7,874 reports
- INGEVITY™+ 7841Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes15 deaths7,419 reports
- Tendril™ STSSt. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes190 deaths6,776 reports
- INGEVITY™+ 7842Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes21 deaths5,995 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes50 deaths5,027 reports
- INGEVITY™ MRI 7742Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes24 deaths3,967 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.
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