Sprint Quattro Secure® 694758Recalls & reported problems
Medtronic, Inc. · LEAD 694758 US FPA QUAD · Class 3 · Implant
Quick summary
This Medtronic Sprint Quattro Secure is a wire lead that connects a pacemaker or defibrillator to the heart. Many reports describe the lead reading electrical signals incorrectly, high electrical resistance readings, and breaks in the lead, and some mention infection or shocks. The records include 1,932 reports, 1,249 injuries and 25 deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,937
- Deaths reported
- 25
- Injuries reported
- 1,252
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,937 adverse event reports that list this exact device (DI 00613994249876), received between Feb 11, 2013 and Sep 30, 2026 — classified as 25 deaths, 1,252 injuries, 660 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (707 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Over-Sensing707
- High impedance684
- Fracture469
- Signal Artifact/Noise389
- Impedance Problem375
- High Capture Threshold247
- Adverse Event Without Identified Device or Use Problem179
- Under-Sensing136
Patient problems
- No Clinical Signs, Symptoms or Conditions806
- No Known Impact Or Consequence To Patient671
- Unspecified Infection141
- Shock from Patient Lead(s)108
- No Consequences Or Impact To Patient83
- Syncope/Fainting21
- Dizziness16
- Erosion16
Recent adverse event reports
The 25 most recent of 1,937 reports, in the reporter's own words as published by the FDA.
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 28, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924096 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erythema; Medical device site infection; Swelling/ Edema
MAUDE report 50903247 ↗InjurySep 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829460 ↗MalfunctionSep 15, 2026Impedance Problem
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected events in progress. An abrupt drop of P wave was noted during this session. It was further reported that there was an RV tip to RV coil impedance warning. The RA lead and the RV lead remain in use. No patient complications have been reported as a result of this event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766627 ↗MalfunctionSep 14, 2026Over-Sensing; Decreased Sensitivity; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762407 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection. The Implantable Cardioverter Defibrillator (ICD) system was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50756625 ↗InjurySep 1, 2026Fracture
It was reported that the Right Ventricular (RV) lead had a suspected high voltage RV coil fracture. 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 50550180 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to pocket infection. No further patient complications have been reported as a result of this event..
Patient problems: Medical device site infection
MAUDE report 50487566 ↗MalfunctionAug 17, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279215 ↗MalfunctionAug 16, 2026High impedance; Impedance Problem
It was reported that the Right Ventricular (RV) lead triggered an alert for elevated pacing impedance, which appeared to be a physiologic interaction with the RVR electrode as the impedance rise was slow and steady. 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 50265861 ↗InjuryAug 13, 2026Decreased Sensitivity
It was reported that the Right Ventricular (RV) lead exhibited diminished sensing. Reprogramming occurred and 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 50236654 ↗MalfunctionAug 12, 2026High impedance; Capturing Problem; Impedance Problem
Patient problems: Tachycardia
MAUDE report 50226763 ↗MalfunctionAug 10, 2026Impedance Problem
It was reported that the Right Ventricular (RV) lead exhibited RV and Superior Vena Cava (SVC) defibrillation intermittent impedance drops. 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 50196366 ↗InjuryAug 4, 2026Signal Artifact/Noise; Over-Sensing; High Capture Threshold
It was reported that a Lead Integrity Alert (LIA) triggered on the Right Ventricular (RV) lead due to High Rate Non-Sustained episodes and short ventricular intervals. Capture thresholds were noted to be high and the lead was oversensing. Another LIA triggered the following day and noise was observed. A new spike in Non-Sustained Ventricular Tachycardia episodes was noted. 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 50126589 ↗InjuryJul 31, 2026Capturing Problem
It was reported that a patient with cardiomyopathy attributed to an apical infarct experienced rising right ventricular (RV) lead th resholds, and the patient was hospitalized. The patient reached Elective Replacement Indicator (ERI) at a normal interval, and the decision was made to perform a lead revision at that time. The RV lead was explanted and replaced. The patient outcome was reported as alive with no injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099848 ↗MalfunctionJul 29, 2026Over-Sensing; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070674 ↗MalfunctionJul 10, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785589 ↗InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION WITH BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Bacteremia; Unspecified Infection
MAUDE report 25766212 ↗MalfunctionJul 7, 2026Low impedance; Decreased Sensitivity; Capturing Problem; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) LOW PACING IMPEDANCE, RISING THRESHOLD TREND AND HIGH RV THRESHOLD. THERE WAS ALSO A DECREASE IN SENSING OVER TIME. 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 25733997 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. GROWTH WAS NOTED ON THE SUPERIOR VENA CAVA (SVC) COIL OF THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Medical device site infection
MAUDE report 25695206 ↗MalfunctionJun 26, 2026High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (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 25640977 ↗MalfunctionJun 25, 2026High impedance; Unstable Impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR HIGH OUT OF RANGE (OOR) PACING IMPEDANCE AND EXHIBITED VARYING DEFIBRILLATION AND SUPERIOR VENA CAVA (SVC) 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 25625948 ↗MalfunctionJun 25, 2026High impedance; Impedance Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR RVTIP TO RVCOIL HIGH/UNDEFINED PACING IMPEDANCE. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED SPIKES IN BOTH RVCOIL AND SVCCOIL. 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 25625940 ↗InjuryJun 24, 2026Over-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CROSS TALK WITH CROSS CHAMBER OVERSENSING AND OCCASIONAL PACING INHIBITION. THE PATIENT EXPERIENCED PRE-SYNCOPE, SYNCOPE, AND ASYSTOLE. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Asystole; Presyncope; Syncope/Fainting
MAUDE report 25611777 ↗
Other permanent pacemaker Electrode devices
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- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode124 deaths8,405 reports
- Capsurefix® Novus 5076-45Medtronic, Inc. · permanent pacemaker Electrode85 deaths7,050 reports
- CapSureFix Novus MRI™ SureScan™ 407652Medtronic, Inc. · permanent pacemaker Electrode69 deaths6,097 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · permanent pacemaker Electrode56 deaths4,850 reports
- Sprint Quattro Secure® 694765Medtronic, Inc. · permanent pacemaker Electrode73 deaths3,852 reports
- Attain Performa™ MRI SureScan™ 429888Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,377 reports
- CapSureFix Novus MRI™ SureScan™ 407645Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,370 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.