Sprint Quattro Secure MRI™ SureScan™ 6947M62 (UDI 00643169356627)Recalls & reported problems
Medtronic, Inc. · LEAD 6947M62 QUATTRO SECURE MRI US · Class 3 · Implant
All models of Medtronic Sprint Quattro Lead (67) · Sprint Quattro Secure MRI SureScan (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Sprint Quattro Secure MRI pacing lead has 2,587 adverse event reports, including 42 deaths and 1,404 injuries. Many reports describe the lead misreading heartbeats or electrical noise, trouble pacing the heart, and inappropriate shocks, and some mention infection. 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
- 2,612
- Deaths reported
- 42
- Injuries reported
- 1,415
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,612 adverse event reports that list this exact device (DI 00643169356627), received between Dec 9, 2016 and Sep 30, 2026 — classified as 42 deaths, 1,415 injuries, 1,155 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (875 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
- Over-Sensing875
- Adverse Event Without Identified Device or Use Problem560
- Under-Sensing319
- High Capture Threshold277
- High impedance272
- Signal Artifact/Noise219
- Impedance Problem209
- Decreased Sensitivity178
Patient problems
- No Clinical Signs, Symptoms or Conditions1,197
- No Known Impact Or Consequence To Patient461
- Unspecified Infection420
- Shock from Patient Lead(s)133
- No Consequences Or Impact To Patient84
- Erosion40
- Erythema38
- Syncope/Fainting34
Recent adverse event reports
The 25 most recent of 2,612 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture; High impedance; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952437 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection; Sepsis
MAUDE report 50903170 ↗MalfunctionSep 24, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited "some kind of oversensing" during a High Rate-Nonsustained episode. 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 50889281 ↗MalfunctionSep 23, 2026Signal Artifact/Noise; Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876281 ↗MalfunctionSep 23, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874905 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection and septic shock. A leadless Implantable Pulse Generator (IPG) was implanted. No further patient complications have been reported as a result of this event.
Patient problems: Septic Shock; Unspecified Infection
MAUDE report 50870656 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50811505 ↗InjurySep 17, 2026Fracture; High impedance; Over-Sensing; Unstable Impedance
It was reported that the Right Ventricular (RV) lead exhibited confirmed High Voltage Superior Vena Cava (SVC) Coil fracture, high SVC coil impedance, high Sensing Integrity Counter (SIC), variability in RV pace/sense impedance. The RV lead was capped, and remains in the patient. The RA lead 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 50808585 ↗MalfunctionSep 17, 2026Pacing Problem; Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited undersensing which resulted in inappropriate ventricular 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 50806077 ↗MalfunctionSep 16, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793067 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacterial Infection; Sepsis; Unspecified Infection
MAUDE report 50780339 ↗InjurySep 15, 2026Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing
It was reported that the Right Ventricular (RV) lead was broken. 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 50780054 ↗InjurySep 15, 2026Insufficient Device Problem Information
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was removed for unknown reasons. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771859 ↗InjurySep 14, 2026Fracture; High impedance; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759685 ↗MalfunctionSep 14, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS). 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 50752665 ↗InjurySep 11, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742573 ↗InjurySep 11, 2026Defibrillation/Stimulation Problem
It was reported that short circuit protection was triggered during an episode of high voltage therapy resulting in less than the programmed high voltage energy being delivered and an alert was triggered. The Implantable Cardioverter Defibrillator (ICD was explanted and replaced and the Right Ventricular (RV) 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 50736992 ↗MalfunctionSep 11, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited oversensing. 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 50734607 ↗MalfunctionSep 9, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited intermittent T-Wave Oversensing (TWOS). Additionally, the patient rec eived inappropriate therapy for Atrial Fibrillation (AF) with Rapid Ventricular Response (RVR) that was detected as Ventricular Fibrillation (VF). The Cardiac Resynchronization Therapy Defibrillator (CRT-D) and RV lead remain 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 50693269 ↗MalfunctionSep 8, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680307 ↗MalfunctionSep 8, 2026Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited undersensing. 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 50673093 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced bacteremia leading to septicemia post generator change. The patient was hospitalized and treated with antibiotics. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system remains in use. The patient is a part icipant in a clinical study. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia
MAUDE report 50671225 ↗MalfunctionSep 3, 2026Low impedance
It was reported that the Right Ventricular (RV) lead exhibited low pacing impedance. 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 50587006 ↗MalfunctionSep 2, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50560370 ↗InjuryAug 31, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
It was reported that the Right Ventricular (RV) lead exhibited P-wave Oversensing (PWOS) resulting in an inappropriate shock. The RV lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50526078 ↗
Other permanent pacemaker Electrode devices
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · permanent pacemaker Electrode136 deaths16,004 reports
- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode124 deaths8,405 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
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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