Sprint Quattro Secure S MRI™ SureScan™ 6935M62 (UDI 00643169356566)Recalls & reported problems
Medtronic, Inc. · LEAD 6935M62 QUATTRO SECURE S MRI US · 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 MRI lead has 14,284 adverse event reports, including 221 deaths and 7,759 injuries. Many describe the lead sensing heartbeats wrongly, either over-sensing or under-sensing, or showing high impedance or a high capture threshold. Some patients report infections, bacteria in the blood, or shocks from the lead, and some reports describe the lead being replaced. 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
- 14,405
- Deaths reported
- 221
- Injuries reported
- 7,808
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14,405 adverse event reports that list this exact device (DI 00643169356566), received between Dec 9, 2016 and Sep 30, 2026 — classified as 221 deaths, 7,808 injuries, 6,375 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (5,275 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
- Over-Sensing5,275
- Adverse Event Without Identified Device or Use Problem2,940
- High impedance1,586
- Under-Sensing1,554
- High Capture Threshold1,481
- Impedance Problem1,313
- Signal Artifact/Noise1,255
- Fracture1,004
Patient problems
- No Clinical Signs, Symptoms or Conditions7,641
- Unspecified Infection2,035
- No Known Impact Or Consequence To Patient1,904
- Shock from Patient Lead(s)562
- No Consequences Or Impact To Patient422
- Bacteremia215
- Bacterial Infection199
- Sepsis187
Recent adverse event reports
The 25 most recent of 14,405 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 50953722 ↗InjurySep 30, 2026Fracture; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951647 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) resulting in misclassification of arrhythmia episode type. 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 50951242 ↗MalfunctionSep 30, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949700 ↗MalfunctionSep 30, 2026Fracture; Over-Sensing; Impedance Problem; Unstable Impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948625 ↗MalfunctionSep 30, 2026High impedance
It was reported that the Right Ventricular (RV) lead exhibited Out of Range (OOR) high defibrillation impedance. 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 50948569 ↗MalfunctionSep 30, 2026Under-Sensing
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) experienced a partial electrical reset where diagnostic data such as pacing percentages and rate histograms were cleared, however parameter values remained unchanged. The CRT-D remains in use. It was reported that the Right Ventricular (RV) lead undersensed multiple beats on a treated Ventricular Fibrillation (VF) episode though there was no observed impact to overall device function or performance. 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 50947090 ↗InjurySep 30, 2026High impedance; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941471 ↗MalfunctionSep 29, 2026Signal Artifact/Noise; Over-Sensing; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940152 ↗MalfunctionSep 29, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938297 ↗MalfunctionSep 29, 2026Pacing Problem; Under-Sensing
Patient problems: Syncope/Fainting
MAUDE report 50937608 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936866 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50935723 ↗InjurySep 29, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem
It was reported that the Right Ventricular (RV) lead exhibited high, undefined defibrillation impedances and it was suspected that the lead had a high voltage fracture. The RV lead had triggered a Lead Integrity Alert (LIA) due to High-Rate Non-Sustained episodes and an elevated Sensing Integrity Counter (SIC). It was noted that the RV lead oversensing of non-physiologic intervals/noise resulted in pacing inhibition and the misclassification of High-Rate Non-Sustained episodes. 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 50935008 ↗InjurySep 29, 2026Signal Artifact/Noise; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934692 ↗MalfunctionSep 29, 2026High Capture Threshold
It was reported that the patient experienced ongoing phrenic nerve stimulation during Left Ventricular (LV) lead pacing. The LV lead and Right Ventricular (RV) lead also exhibited high thresholds. The LV lead was reprogrammed, and the leads remain in use. No further patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933224 ↗MalfunctionSep 29, 2026High impedance; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930495 ↗MalfunctionSep 28, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926039 ↗MalfunctionSep 28, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing
Patient problems: Shock from Patient Lead(s)
MAUDE report 50923838 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a suspected Cardiac Resynchronization Therapy Defibrillator (CRT-D) system infection. The CRT-D system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50923728 ↗MalfunctionSep 28, 2026Signal Artifact/Noise; Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited noise, oversensing, and T-Wave Oversensing (TWOS) resulting in miscla ssification of 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 50920155 ↗InjurySep 28, 2026Signal Artifact/Noise; Pacing Problem
Patient problems: Asystole; Dizziness; Syncope/Fainting
MAUDE report 50916228 ↗MalfunctionSep 28, 2026Low impedance
It was reported that the Right Ventricular (RV) lead exhibited Out of Range (OOR) low pacing impedance. 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 50915197 ↗InjurySep 28, 2026Signal Artifact/Noise; Impedance Problem
It was reported that the Right Ventricular (RV) lead triggered warning for RV defibrillation coil out of range multiple times that was noted to be rising and showed spike in impedance and noise noted on the electrograms (EGM). 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 50914835 ↗MalfunctionSep 28, 2026Low impedance
It was reported that an alert triggered for low pacing 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 50912838 ↗
Other Permanent defibrillator electrodes devices
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes333 deaths30,581 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
- ENDOTAK RELIANCE® SG 0292Boston Scientific Corporation · Permanent defibrillator electrodes16 deaths3,197 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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