Sprint Quattro Secure S DXAC/DSPRecalls & 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
- 1,742
- Deaths reported
- 16
- Injuries reported
- 1,080
- Recalls
- 0
We found 10 models of Sprint Quattro Secure S DXAC/DSP by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,742 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2013 and Sep 29, 2026 — classified as 16 deaths, 1,080 injuries, 646 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (710 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 DXAC/DSP problems
Device problems
- Over-Sensing710
- High impedance569
- Fracture377
- Signal Artifact/Noise348
- Impedance Problem336
- Adverse Event Without Identified Device or Use Problem222
- High Capture Threshold185
- Under-Sensing132
Patient problems
- No Clinical Signs, Symptoms or Conditions729
- No Known Impact Or Consequence To Patient534
- Unspecified Infection173
- Shock from Patient Lead(s)108
- No Consequences Or Impact To Patient77
- Dizziness22
- Syncope/Fainting16
- Erythema15
Sprint Quattro Secure S DXAC/DSP models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sprint Quattro Secure S™ DXAC/DSP 693565Permanent defibrillator electrodes11 deaths1,012 reports
- Sprint Quattro Secure S™ DXAC/DSP 693558Permanent defibrillator electrodes3 deaths607 reports
- SPRINT QUATTRO SECURE S™ DXAC/DSP 693565permanent pacemaker Electrode54 reports
- SPRINT QUATTRO SECURE S™ DXAC/DSP 693558permanent pacemaker Electrode2 deaths27 reports
- SPRINT QUATTRO SECURE S™ DXAC/DSP 693575Implantable cardioverter defibrillator (non-CRT)15 reports
- Sprint Quattro Secure S™ DXAC/DSP 693575Permanent defibrillator electrodes9 reports
- SPRINT QUATTRO SECURE S™ DXAC/DSP 693552Implantable cardioverter defibrillator (non-CRT)9 reports
- Sprint Quattro Secure S™ DXAC/DSP 693552Permanent defibrillator electrodes7 reports
- Sprint Quattro Secure S™ DXAC/DSP 6935100permanent pacemaker Electrode1 report
- SPRINT QUATTRO SECURE S™ DXAC/DSP 6935100permanent pacemaker Electrode1 report
Recent Sprint Quattro Secure S DXAC/DSP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937723 ↗InjurySep 29, 2026High impedance; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935771 ↗MalfunctionSep 28, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922020 ↗MalfunctionSep 16, 2026Unstable Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794176 ↗MalfunctionSep 15, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to High-Rate Non-Sustained episodes and Sensing Integrity Counter (SIC) while the patient was resting in bed watching television. 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 50773873 ↗MalfunctionSep 10, 2026High impedance
It was reported that the Right Ventricular (RV) lead exhibited high/undefined pacing 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 50715809 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696614 ↗MalfunctionSep 8, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675045 ↗InjuryAug 27, 2026Device Dislodged or Dislocated
It was reported by the patient that the physician had to go back and put a longer wire in because "it came off". No additional information could be obtained through follow-up with the clinic. The Right Ventricular (RV) lead was inactivated and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484103 ↗MalfunctionAug 27, 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 50470111 ↗MalfunctionAug 17, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) post-ventricular sensing. 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 50276457 ↗MalfunctionAug 14, 2026Fracture; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263000 ↗InjuryAug 11, 2026High impedance
It was reported that high out-of-range impedance was observed on the defibrillation coil of the implanted right ventricular (RV) lead. The patient underwent surgical replacement of the RV lead which was capped. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210184 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to a pocket infection. Additionally, the patient experienced swelling. A new ICD system was implanted two days later. No further patient complications have been reported as a result of this event.
Patient problems: Medical device site infection; Swelling/ Edema
MAUDE report 50201366 ↗MalfunctionAug 4, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50134270 ↗
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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