CapSure Sense MRI™ SureScan™ 457445 (UDI 00643169410916)Recalls & reported problems
Medtronic, Inc. · LEAD 457445 MRI US BI RCMCRD MVC · Class 3 · Implant
All models of CapSure Sense MRI SureScan (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic CapSure Sense MRI pacemaker lead has 1,400 FDA adverse event reports, with 594 injuries, 790 malfunctions and 16 deaths. The reports mostly describe the lead missing heart signals, needing high energy to trigger a heartbeat, and moving out of place. Some mention infections or chest pain. 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
- 1,416
- Deaths reported
- 16
- Injuries reported
- 600
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,416 adverse event reports that list this exact device (DI 00643169410916), received between Aug 9, 2017 and Sep 30, 2026 — classified as 16 deaths, 600 injuries, 800 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (610 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-Sensing610
- High Capture Threshold310
- Device Dislodged or Dislocated224
- Adverse Event Without Identified Device or Use Problem162
- Pacing Problem147
- Over-Sensing138
- Failure to Capture124
- Decreased Sensitivity79
Patient problems
- No Clinical Signs, Symptoms or Conditions896
- No Known Impact Or Consequence To Patient159
- Unspecified Infection118
- No Consequences Or Impact To Patient40
- Chest Pain24
- Dyspnea24
- Dizziness23
- Bradycardia18
Recent adverse event reports
The 25 most recent of 1,416 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed a pocket infection. The Implantable Pulse Generator (IPG) sysetm was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50945880 ↗MalfunctionSep 30, 2026Under-Sensing
It was 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 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 50945078 ↗MalfunctionSep 28, 2026Pacing Problem; Under-Sensing
It was reported that the Right Ventricular (RV) lead triggered multiple alerts for high RV defibrillation impedance. The Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting 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 50921549 ↗MalfunctionSep 28, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917053 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an infection. The Implantable Pulse Generator (IPG) system was removed and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50895766 ↗MalfunctionSep 18, 2026High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited high thresholds. 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 50824497 ↗MalfunctionSep 10, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722502 ↗MalfunctionSep 9, 2026Failure to Capture; High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited loss of capture and high thresholds. 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 50689444 ↗InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced pneoumothorax. The leads remain in use. No further patient complications have been reported as a result of this event.
Patient problems: Pneumothorax
MAUDE report 50666410 ↗MalfunctionSep 8, 2026Failure to Capture; Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited over sensing and loss of capture on stored episodes. 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 50666169 ↗MalfunctionSep 3, 2026Electrical /Electronic Property Problem; High Capture Threshold
It was reported that approximately six weeks post implant the Right Atrial (RA) lead exhibited an Atrial Lead Position Check failure and high thresholds. 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 50586221 ↗MalfunctionSep 2, 2026Pacing Problem; Under-Sensing
It was also reported that the RA lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AF) events resulting in unnecessary pacing at times.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567704 ↗InjurySep 2, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient's transvenous Implantable Pulse Generator (IPG) system was explanted as it was causing them discomfort. A leadless IPG was implanted instead. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort
MAUDE report 50562048 ↗MalfunctionSep 2, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558271 ↗MalfunctionSep 1, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541108 ↗MalfunctionSep 1, 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 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 50538669 ↗MalfunctionAug 31, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518272 ↗InjuryAug 28, 2026Under-Sensing; Decreased Sensitivity
It was reported that the Right Atrial (RA) lead exhibited undersensing and diminished sensing. The RA 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 50493305 ↗MalfunctionAug 27, 2026High Capture Threshold
It was reported that the remote monitoring network transmission was not exported to the monitoring inbox for review. A ticket was created and the issue was under investigation. It was further reported that the Right Atrial (RA) lead displayed high capture 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 50479178 ↗MalfunctionAug 27, 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 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 50468401 ↗MalfunctionAug 26, 2026Under-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. 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 50453724 ↗MalfunctionAug 26, 2026Signal Artifact/Noise; Fracture; High impedance
It was reported that the Right Atrial (RA) lead exhibited noise, high impedance and was fractured. 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 50451258 ↗MalfunctionAug 21, 2026Capturing Problem; Device Dislodged or Dislocated; Impedance Problem
It was reported that the Right Atrial (RA) lead had exhibited an slow and steady increase in RA pacing impedance and rise in threshold. The lead was stated to have been dislodged. It was stated that the patient had a fall from their dental chair last month but was not sure if the fall was enough to impact a dislodgement of the lead. The RA impedance alert tone was turn off and alert set to higher limit. The lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: Fall
MAUDE report 50369500 ↗MalfunctionAug 20, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing on stored electrograms (EGM) during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in 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 50340255 ↗MalfunctionAug 18, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50297110 ↗
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
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes40 deaths5,000 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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