Sprint Quattro Secure S MRI SureScanRecalls & reported problems across all models
Medtronic, Inc. · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23,549
- Deaths reported
- 353
- Injuries reported
- 12,857
- Recalls
- 0
We found 7 models of Sprint Quattro Secure S MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 23,549 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2016 and Sep 30, 2026 — classified as 353 deaths, 12,857 injuries, 10,338 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (8,549 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 S MRI SureScan problems
Device problems
- Over-Sensing8,549
- Adverse Event Without Identified Device or Use Problem4,669
- High impedance2,831
- Under-Sensing2,470
- High Capture Threshold2,424
- Impedance Problem2,233
- Signal Artifact/Noise2,123
- Fracture1,748
Patient problems
- No Clinical Signs, Symptoms or Conditions12,605
- Unspecified Infection3,179
- No Known Impact Or Consequence To Patient3,127
- Shock from Patient Lead(s)908
- No Consequences Or Impact To Patient718
- Bacteremia327
- Erythema296
- Bacterial Infection294
Sprint Quattro Secure S MRI SureScan models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Permanent defibrillator electrodes221 deaths14,405 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55Permanent defibrillator electrodes116 deaths7,750 reports
- Sprint Quattro Secure S MRI™ SureScan™ 693565permanent pacemaker Electrode8 deaths695 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Permanent defibrillator electrodes3 deaths309 reports
- Sprint Quattro Secure S MRI™ SureScan™ 693558permanent pacemaker Electrode3 deaths278 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55permanent pacemaker Electrode2 deaths102 reports
- Sprint Quattro Secure S MRI™ SureScan™ 693565Implantable cardioverter defibrillator (non-CRT)10 reports
Recent Sprint Quattro Secure S 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; Wound Dehiscence
MAUDE report 50955142 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 50953722 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cardiac Arrest; Cardiac Tamponade; Perforation
MAUDE report 50952740 ↗MalfunctionSep 30, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952133 ↗InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated
Patient problems: Shock from Patient Lead(s); Twiddlers Syndrome
MAUDE report 50951886 ↗InjurySep 30, 2026Fracture; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951647 ↗MalfunctionSep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951293 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) resulting in misclassification of arrhythmia episode type. 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 50951242 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to infection with bacteremia. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Unspecified Infection
MAUDE report 50951211 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950974 ↗InjurySep 30, 2026Failure to Capture; High impedance; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949809 ↗MalfunctionSep 30, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949700 ↗InjurySep 30, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Unstable Impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949141 ↗MalfunctionSep 30, 2026Fracture; Over-Sensing; Impedance Problem; Unstable Impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948625 ↗MalfunctionSep 30, 2026High impedance
It was reported that the Right Ventricular (RV) lead exhibited Out of Range (OOR) high defibrillation 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 50948569 ↗
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
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
- Medtronic Azure Pacemaker12 models · 16,566 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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