Sprint Quattro SecureRecalls & reported problems across all models
Medtronic, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8,784
- Deaths reported
- 139
- Injuries reported
- 5,531
- Recalls
- 0
We found 10 models of Sprint Quattro Secure by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 8,784 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2013 and Sep 30, 2026 — classified as 139 deaths, 5,531 injuries, 3,114 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (3,277 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 problems
Device problems
- Over-Sensing3,277
- High impedance2,726
- Fracture1,863
- Signal Artifact/Noise1,669
- Impedance Problem1,575
- Adverse Event Without Identified Device or Use Problem1,101
- High Capture Threshold1,048
- Under-Sensing726
Patient problems
- No Clinical Signs, Symptoms or Conditions3,703
- No Known Impact Or Consequence To Patient2,719
- Unspecified Infection876
- Shock from Patient Lead(s)526
- No Consequences Or Impact To Patient380
- Erosion88
- Sepsis77
- Syncope/Fainting71
Sprint Quattro Secure models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sprint Quattro Secure® 694765permanent pacemaker Electrode73 deaths3,852 reports
- Sprint Quattro Secure® 694758permanent pacemaker Electrode25 deaths1,937 reports
- Sprint Quattro Secure® 6947M62Permanent defibrillator electrodes18 deaths1,158 reports
- Sprint Quattro Secure® 6947M62Permanent defibrillator electrodes10 deaths796 reports
- Sprint Quattro Secure® 6947M55permanent pacemaker Electrode8 deaths603 reports
- Sprint Quattro Secure® 6947M55permanent pacemaker Electrode4 deaths391 reports
- Sprint Quattro Secure® 6947M72permanent pacemaker Electrode1 death24 reports
- Sprint Quattro Secure® 6947M72permanent pacemaker Electrode17 reports
- Sprint Quattro Secure® 6947100permanent pacemaker Electrode4 reports
- Sprint Quattro Secure® 6947M97permanent pacemaker Electrode2 reports
Recent Sprint Quattro Secure adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954786 ↗MalfunctionSep 30, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951828 ↗MalfunctionSep 30, 2026High impedance
It was reported that the Right Ventricular (RV) lead exhibited undefined high Superior Vena Cava (SVC) defibrillation impedance. 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 50948908 ↗MalfunctionSep 30, 2026Low impedance; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited undefined low pacing impedance. It was also noted that the RV lead exhibited high thresholds. 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 50948547 ↗MalfunctionSep 30, 2026High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high 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 50947271 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the Right Ventricular (RV) lead was capped and replaced 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 50946484 ↗InjurySep 29, 2026Signal Artifact/Noise; High impedance; Over-Sensing
Patient problems: Palpitations
MAUDE report 50941150 ↗InjurySep 29, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940642 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Discomfort; Erosion; Medical device site infection
MAUDE report 50940015 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to an infection resulting in discomfort, erosion, redness, swelling and wound dehiscence. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Erosion; Erythema; Swelling/ Edema; Unspecified Infection; Wound Dehiscence
MAUDE report 50934464 ↗InjurySep 29, 2026Fracture; High impedance; Over-Sensing; Unstable Impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926873 ↗InjurySep 28, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924096 ↗InjurySep 28, 2026Fracture
It was reported that the Right Ventricular (RV) lead had a confirmed high-voltage fracture. 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 50917371 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erythema; Medical device site infection; Swelling/ Edema
MAUDE report 50903247 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced an infection. The device system was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50897497 ↗
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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