Sprint Quattro Secure S MRI™ SureScan™ 6935M62 (UDI 00763000180126)Recalls & reported problems
Medtronic, Inc. · LEAD 6935M62 MRI US DF4 RCMCRD · Class 3 · Implant
All models of Medtronic Sprint Quattro Lead (67) · Sprint Quattro Secure S MRI SureScan (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Sprint Quattro Secure S defibrillator lead is a wire placed in the heart. Of its 275 reports, 141 are injury reports, 131 are malfunction reports, and 3 deaths are listed. Many describe incorrect heartbeat sensing and noise, and some describe infections or a heart wall perforation. All 275 reports are from the latest year. 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
- 309
- Deaths reported
- 3
- Injuries reported
- 156
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 309 adverse event reports that list this exact device (DI 00763000180126), received between Nov 3, 2025 and Sep 30, 2026 — classified as 3 deaths, 156 injuries, 150 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (50 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem79
- High Capture Threshold50
- Over-Sensing44
- Under-Sensing36
- Signal Artifact/Noise25
- High impedance21
- Appropriate Device Problem Term/Code Not Available18
- Capturing Problem18
Patient problems
- No Clinical Signs, Symptoms or Conditions202
- Unspecified Infection35
- Medical device site infection19
- Purulent Discharge16
- Erythema14
- Pain11
- Swelling/ Edema10
- Bacteremia9
Recent adverse event reports
The 25 most recent of 309 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cardiac Arrest; Cardiac Tamponade; Perforation
MAUDE report 50952740 ↗InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated
Patient problems: Shock from Patient Lead(s); Twiddlers Syndrome
MAUDE report 50951886 ↗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 29, 2026Low impedance; High Capture Threshold
It was reported that the Right Ventricular (RV) lead triggered alerts due to high thresholds and also an alert for low, out-of-range pacing impedance. The impedance measurement was noted to be consistent with historical values. 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 50933442 ↗MalfunctionSep 25, 2026Capturing Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903739 ↗InjurySep 25, 2026High Capture Threshold; Unstable Capture Threshold
Patient problems: Pericardial Effusion
MAUDE report 50902376 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection; Purulent Discharge
MAUDE report 50890942 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to infection with fever, bacteremia, and purulent discharge/pus. The organism was identified as Staphylococcus aureus. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Bacterial Infection; Fever; Purulent Discharge
MAUDE report 50885223 ↗MalfunctionSep 24, 2026Over-Sensing; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high capture threshold and increased 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 50884600 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately one month post replacement procedure, the patient developed a pocket infection. It was noted that the patient developed purulent discharge/pus. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a Leadless Implantable Pulse Generator (IPG). No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50877005 ↗MalfunctionSep 23, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872638 ↗MalfunctionSep 23, 2026High Capture Threshold; Unstable Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high capture 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 50869322 ↗MalfunctionSep 18, 2026High impedance; Capturing Problem; Impedance Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829011 ↗InjurySep 18, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828369 ↗MalfunctionSep 18, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827807 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50827494 ↗InjurySep 18, 2026Decreased Sensitivity; Capturing Problem; High Capture Threshold; Unstable Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819578 ↗InjurySep 17, 2026High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high thresholds. The lead was explanted and replaced. No patient comp lications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809544 ↗MalfunctionSep 17, 2026High impedance
It was reported that the Right Ventricular (RV) lead exhibited high Out of Range (OOR) pacing impedance several times during an implant procedure. The RV lead was removed and replaced with a new lead. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809243 ↗MalfunctionSep 17, 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 50808828 ↗InjurySep 17, 2026Failure to Capture; Device Dislodged or Dislocated
It was reported that the Right Ventricular (RV) lead became dislodged and exhibited loss of capture. The RV lead was repositioned and 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 50806853 ↗MalfunctionSep 17, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) noted on a stored episode resulting in misc lassification of arrhythmia episode type. 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 50806193 ↗InjurySep 17, 2026Over-Sensing
It was reported that post implant the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) post ventricular pacing. The RV lead also triggered a Lead Integrity Alert (LIA) due to High Rate Non-Sustained episodes and Sensing Integrity Counter (SIC). Repr ogramming was performed but TWOS was still present. Additionally, the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. Reprogramming was also performed for the RA lead. The RV and RA leads 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 50805601 ↗MalfunctionSep 17, 2026Over-Sensing
It was reported that one day after Right Ventricular (RV) lead implant, the patient experienced a low heart rate in the 30¿s beats per minute (bpm). The patient was symptomatic and telemetry indicated the low rate for an extended period and T-Wave Oversensing (TWOS). It was suspected that the TWOS was clinically related. The lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Bradycardia
MAUDE report 50804668 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) device system was explanted due to a pocket infection with purulent discharge. No further patient complications have been reported as a result of this event.
Patient problems: Medical device site infection; Purulent Discharge
MAUDE report 50787295 ↗
Other Permanent defibrillator electrodes devices
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes333 deaths30,581 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Medtronic, Inc. · Permanent defibrillator electrodes221 deaths14,405 reports
- Capsurefix® Novus 5076-52Medtronic, Inc. · Permanent defibrillator electrodes111 deaths9,860 reports
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes80 deaths8,280 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55Medtronic, Inc. · Permanent defibrillator electrodes116 deaths7,750 reports
- Durata™ 7122Q-58St. Jude Medical, Inc. · Permanent defibrillator electrodes151 deaths6,202 reports
- Durata™ 7122Q-65St. Jude Medical, Inc. · Permanent defibrillator electrodes86 deaths4,773 reports
- Capsurefix® Novus 5076-58Medtronic, Inc. · Permanent defibrillator electrodes47 deaths4,587 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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