CapSureFix Novus MRI™ SureScan® 5076-58 (UDI 00643169633766)Recalls & reported problems
Medtronic, Inc. · LEAD 5076-58 MRI US RCMCRD · 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 8,343 adverse event reports, including 124 deaths and 5,010 injuries. The reports mostly describe the lead missing or misreading heartbeats, slipping out of position, and high electrical thresholds, 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
- 8,405
- Deaths reported
- 124
- Injuries reported
- 5,016
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8,405 adverse event reports that list this exact device (DI 00643169633766), received between Dec 7, 2017 and Sep 30, 2026 — classified as 124 deaths, 5,016 injuries, 3,265 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (1,552 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
- Adverse Event Without Identified Device or Use Problem2,011
- Under-Sensing1,552
- High Capture Threshold1,500
- Device Dislodged or Dislocated1,167
- Failure to Capture981
- Over-Sensing957
- High impedance780
- Decreased Sensitivity567
Patient problems
- No Clinical Signs, Symptoms or Conditions3,995
- Unspecified Infection1,205
- No Known Impact Or Consequence To Patient876
- Bradycardia275
- Cardiac Perforation236
- Chest Pain235
- No Consequences Or Impact To Patient217
- Dizziness205
Recent adverse event reports
The 25 most recent of 8,405 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Capturing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950790 ↗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 50945856 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced chest pain and discomfort due to cardiac perforation. The lead was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Cardiac Perforation; Discomfort
MAUDE report 50945789 ↗InjurySep 30, 2026Device Dislodged or Dislocated
It was reported that the Right Ventricular (RV) lead exhibited dislodgement. 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 50945438 ↗InjurySep 30, 2026Failure to Capture; Fracture; Over-Sensing
Patient problems: Asystole; Bradycardia; Dizziness; Presyncope
MAUDE report 50945087 ↗MalfunctionSep 30, 2026High Capture Threshold
It was reported that both the Right Atrial (RA) lead and Right Ventricular (RV) lead exhibited increased thresholds. 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 50943922 ↗MalfunctionSep 29, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited oversensing resulting in misclassification of episode types. 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 50934208 ↗InjurySep 29, 2026Pacing Problem; Under-Sensing
Patient problems: Dizziness; Presyncope
MAUDE report 50934093 ↗MalfunctionSep 29, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932174 ↗MalfunctionSep 29, 2026Capturing Problem
It was reported that the Right Ventricular (RV) lead was exhibiting rising thresholds which had further been reported to have decreased. 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 50930657 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930479 ↗MalfunctionSep 29, 2026High impedance; Capturing Problem; Impedance Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930037 ↗MalfunctionSep 29, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928529 ↗MalfunctionSep 28, 2026Signal Artifact/Noise; Device Sensing Problem
It was reported that the Right Atrial (RA) lead exhibited intermittent undersensing on stored episode(s) resulting in premature termination of episode and inappropriate atrial pacing. It was further noted that noise was observed and low amplitude measurement. It was further reported that the Right Ventricular (RV) lead exhibited variable sensing and noise. 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 50912802 ↗MalfunctionSep 28, 2026High impedance
It was reported that during implant the Right Ventricular (RV) lead exhibited high impedance .The lead was attempted not used. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911952 ↗MalfunctionSep 28, 2026Pacing Problem; Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited under sensing resulting in over pacing. 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 50911937 ↗InjurySep 28, 2026Device Dislodged or Dislocated
It was reported that eight days post implant that the Right Ventricular (RV) lead exhibited a micro-dislodgment. The RV lead was removed and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911143 ↗MalfunctionSep 25, 2026Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited undersensing. 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 50897606 ↗MalfunctionSep 25, 2026Capturing Problem; Impedance Problem; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited an acute drop in pacing impedance and an acute rise to high thresholds. The Left Ventricular (LV) lead also exhibited an acute drop in pacing impedance. 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 50896577 ↗MalfunctionSep 25, 2026Premature Activation; Activation, Positioning or Separation Problem; Positioning Problem
It was reported that during the implant procedure the catheter split. It was further reported that the pacing lead "had difficulty maneuvering" and the lead pulled back. It was further noted that the "screw" of the pacing lead became deployed and was unable to be retracted. The catheter and pacing lead was attempted/not used and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895923 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced twiddlers syndrome. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Twiddlers Syndrome
MAUDE report 50895411 ↗InjurySep 25, 2026Fracture
It was reported that the "wires kept breaking". The Right Atrial (RA) and Right Ventricular (RV) 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 50895255 ↗MalfunctionSep 25, 2026High impedance
It was reported that the Right Atrial (RA) lead exhibited undersensing and an atrial lead position check and high lead impedance was further noted. The Right Ventricular (RV) lead was also noted to exhibit high impedance. 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 50894795 ↗MalfunctionSep 25, 2026Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited under sensing, resulting in over pacing. 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 50894701 ↗MalfunctionSep 24, 2026Signal Artifact/Noise
It was reported that the Right Atrial (RA) lead exhibited over sensing. The RA lead and Right Ventricular (RV) lead exhibited noise. 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 50883065 ↗
Other permanent pacemaker Electrode devices
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · permanent pacemaker Electrode136 deaths16,004 reports
- Capsurefix® Novus 5076-45Medtronic, Inc. · permanent pacemaker Electrode85 deaths7,050 reports
- CapSureFix Novus MRI™ SureScan™ 407652Medtronic, Inc. · permanent pacemaker Electrode69 deaths6,097 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · permanent pacemaker Electrode56 deaths4,850 reports
- Sprint Quattro Secure® 694765Medtronic, Inc. · permanent pacemaker Electrode73 deaths3,852 reports
- Attain Performa™ MRI SureScan™ 429888Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,377 reports
- CapSureFix Novus MRI™ SureScan™ 407645Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,370 reports
- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode40 deaths3,015 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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