Sprint Quattro Secure MRI SureScanRecalls & reported problems across all models
Medtronic, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,163
- Deaths reported
- 63
- Injuries reported
- 2,297
- Recalls
- 0
We found 6 models of Sprint Quattro Secure MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 4,163 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 30, 2026 — classified as 63 deaths, 2,297 injuries, 1,803 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (1,396 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Sprint Quattro Secure MRI SureScan problems
Device problems
- Over-Sensing1,396
- Adverse Event Without Identified Device or Use Problem893
- Under-Sensing483
- High impedance462
- High Capture Threshold459
- Impedance Problem377
- Signal Artifact/Noise369
- Fracture311
Patient problems
- No Clinical Signs, Symptoms or Conditions1,919
- No Known Impact Or Consequence To Patient745
- Unspecified Infection677
- Shock from Patient Lead(s)210
- No Consequences Or Impact To Patient118
- Erosion62
- Erythema58
- Syncope/Fainting54
Sprint Quattro Secure MRI SureScan models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sprint Quattro Secure MRI™ SureScan™ 6947M62permanent pacemaker Electrode42 deaths2,612 reports
- Sprint Quattro Secure MRI™ SureScan™ 6947M55permanent pacemaker Electrode19 deaths1,272 reports
- Sprint Quattro Secure MRI™ SureScan™ 694758Implantable cardioverter defibrillator (non-CRT)1 death153 reports
- Sprint Quattro Secure MRI™ SureScan™ 694765Permanent defibrillator electrodes1 death114 reports
- Sprint Quattro Secure MRI™ SureScan™ 6947M62permanent pacemaker Electrode10 reports
- Sprint Quattro Secure MRI™ SureScan™ 6947M55permanent pacemaker Electrode2 reports
Recent Sprint Quattro Secure MRI SureScan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50954550 ↗MalfunctionSep 30, 2026Fracture; High impedance; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952437 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952425 ↗MalfunctionSep 29, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) noted on the current electrogram (EGM). 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 50935060 ↗MalfunctionSep 28, 2026Over-Sensing
It was reported that the caller inquired whether an adapter was available to convert the Right Ventricular (RV) lead from one connector type to another. The lead type was reviewed, and it was confirmed that no such adapter is available. Additional review indicated a lead integrity warning with findings suggestive of an RV tip conductor issue and intermittent high impedance. It was further reported that that the RV lead triggered a Lead Integrity Alert (LIA) for High Rate-Non-Sustained episodes and Sensing Integrity Counter (SIC). 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 50917339 ↗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 18, 2026Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem
Patient problems: Syncope/Fainting
MAUDE report 50828462 ↗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, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793361 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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