SPRINT QUATTRO SECURE DXAC/DSPRecalls & reported problems across all models
Medtronic, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,363
- Deaths reported
- 14
- Injuries reported
- 849
- Recalls
- 0
We found 7 models of SPRINT QUATTRO SECURE DXAC/DSP by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,363 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2016 and Sep 25, 2026 — classified as 14 deaths, 849 injuries, 500 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (535 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 DXAC/DSP problems
Device problems
- Over-Sensing535
- High impedance401
- Fracture279
- Signal Artifact/Noise264
- Impedance Problem209
- Adverse Event Without Identified Device or Use Problem166
- High Capture Threshold138
- Under-Sensing136
Patient problems
- No Clinical Signs, Symptoms or Conditions580
- No Known Impact Or Consequence To Patient393
- Unspecified Infection138
- Shock from Patient Lead(s)105
- No Consequences Or Impact To Patient70
- Sepsis16
- Syncope/Fainting14
- Erosion12
SPRINT QUATTRO SECURE DXAC/DSP models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sprint Quattro Secure® DXAC/DSP 694765Permanent defibrillator electrodes10 deaths852 reports
- Sprint Quattro Secure® DXAC/DSP 694758permanent pacemaker Electrode3 deaths421 reports
- SPRINT QUATTRO SECURE® DXAC/DSP 694765Implantable cardioverter defibrillator (non-CRT)38 reports
- SPRINT QUATTRO SECURE® DXAC/DSP 694758Permanent defibrillator electrodes31 reports
- Sprint Quattro Secure® DXAC/DSP 694775permanent pacemaker Electrode1 death18 reports
- SPRINT QUATTRO SECURE® DXAC/DSP 694775Permanent defibrillator electrodes2 reports
- SPRINT QUATTRO SECURE® DXAC/DSP 6947100Permanent defibrillator electrodes1 report
Recent SPRINT QUATTRO SECURE 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 25, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902659 ↗InjurySep 11, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Unstable Impedance
It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) for high rate non sustained episodes, RV Bipolar and RVtip to RVcoil high impedance, Sensing Integrity Counter (SIC) and impedance variation. It was also reported that the RV lead exhibited non physiologic noise and probable RVtip conductor, RV Coil, SVC Coil fracture suspected. The RV lead was capped and remains in the patient. A new RV lead was implanted. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736987 ↗MalfunctionSep 11, 2026Signal Artifact/Noise
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734045 ↗MalfunctionSep 9, 2026Over-Sensing
It was reported that the Right Ventricular (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 50696417 ↗MalfunctionSep 8, 2026Signal Artifact/Noise; Over-Sensing
It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to increased Sensing Integrity Counter (SIC) and two or more High Rate-Non Sustained episodes. The lead also exhibited noise. 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 50671179 ↗InjurySep 2, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569149 ↗InjurySep 1, 2026Fracture; Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited oversensing resulting in non-physiologic intervals and triggered a Lead Integrity Alert (LIA) due to High Rate Non-Sustained episodes and Sensing Integrity Counter (SIC). It was further reported that the lead had a suspected high voltage fracture. 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 50547175 ↗MalfunctionSep 1, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545180 ↗MalfunctionAug 27, 2026Signal Artifact/Noise; Over-Sensing
It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) for high-rate non-sustained episodes and Sensing Integrity Counter (SIC). The RV lead also exhibited oversensing and non-physiologic intervals/noise. 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 50479053 ↗MalfunctionAug 26, 2026Under-Sensing
It was further reported that the patient had a heart transplant and the Implantable Cardioverter Defibrillator (ICD) system was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50462135 ↗MalfunctionAug 26, 2026High impedance
It was reported that there was high undefined Superior Vena Cava (SVC) coil impedance on the Right Ventricular (RV) lead. 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 50455660 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) system was removed due infection and erosion. No further patient complications have been reported as a result of this event.
Patient problems: Erosion; Unspecified Infection
MAUDE report 50122709 ↗InjuryJul 30, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead had triggered Lead Integrity Alert (LIA) for elevated Sensing Integrity Counter (SIC) and High Rate Non-Sustained episodes. The RV lead exhibited oversensing. Trouble shooting and and reprogramming was performed but the RV lead triggered LIA again. 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 50086716 ↗InjuryJul 29, 2026Low impedance
It was reported that the Right Ventricular (RV) lead exhibited low Out of Range (OOR) pacing impedance. The RV 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 50077696 ↗MalfunctionJul 10, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT WAS HEARING AN ALERT TONE EVERY FOUR HOURS, INDICATIVE OF A POSSIBLE LEAD INTEGRITY ISSUE. THE RIGHT VENTRICULAR (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 25785288 ↗
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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