Sprint Quattro Secure S MRI™ SureScan™ 6935M55 (UDI 00763000180119)Recalls & reported problems
Medtronic, Inc. · LEAD 6935M55 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 MRI is a thin lead threaded into the heart to carry signals between the heart and an implanted defibrillator or pacemaker. The 86 reports mostly describe the lead sensing the heart's signals incorrectly, needing higher energy to pace the heart, picking up noise, or shifting out of place; some mention infections at the implant site. There are 2 deaths and 48 injuries, and no recalls name this device. All reports came in the last 12 months, up from none the year before.
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
- 102
- Deaths reported
- 2
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00763000180119), received between Nov 14, 2025 and Sep 30, 2026 — classified as 2 deaths, 56 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (24 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 Problem26
- Over-Sensing24
- Under-Sensing14
- High Capture Threshold13
- Failure to Capture8
- Device Dislodged or Dislocated7
- Signal Artifact/Noise7
- Low impedance6
Patient problems
- No Clinical Signs, Symptoms or Conditions62
- Discomfort9
- Medical device site infection8
- Unspecified Infection7
- Wound Dehiscence6
- Erosion4
- Erythema4
- Purulent Discharge4
Recent adverse event reports
The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 50955142 ↗InjurySep 28, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917644 ↗MalfunctionSep 25, 2026Signal Artifact/Noise; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902486 ↗MalfunctionSep 24, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889805 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that shortly after the Cardiac Resynchronization Therapy Defibrillator (CRT-D) implant, the patient experienced a large hematoma on the left side for which incision and drainage was performed on the left side. It was suspected that subsequently the patient developed infection with weakness, bacteremia, erosion and organism identified as Methicillin sensitive staphylococcus aureus (MSSA). The CRT-D system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Bacterial Infection; Erosion; Muscle Weakness/Atrophy
MAUDE report 50870020 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pocket Erosion
MAUDE report 50828533 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Discomfort; Erosion; Erythema; Medical device site infection; Pain; Swelling/ Edema
MAUDE report 50821737 ↗InjurySep 16, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796475 ↗MalfunctionSep 16, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS). 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 50789377 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50741489 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to pocket infection. A few days later a new ICD system was implanted. No further patient complications have been reported as a result of this event.
Patient problems: Medical device site infection
MAUDE report 50734216 ↗MalfunctionSep 11, 2026Over-Sensing
It was reported that a Right Ventricular (RV) Lead Integrity Alert (LIA) triggered due to High Rate Non-Sustained episodes and Sensing Integrity Counter (SIC). 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 50725470 ↗MalfunctionSep 10, 2026Pacing Problem; Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited undersensing. The Cardiac Resynchronization Therapy Defibrillator (CR T-D) exhibited over pacing due to functional atrial undersensing in the refractory / blanking period. The patient experienced dizziness or near syncope. The lead and device remains in use. No patient complications have been reported as a result of this event.
Patient problems: Dizziness; Presyncope
MAUDE report 50714423 ↗InjurySep 2, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572770 ↗MalfunctionSep 2, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568848 ↗MalfunctionSep 1, 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 50548075 ↗MalfunctionSep 1, 2026Failure to Capture; Low impedance; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547368 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that one day after the implant of the Right Ventricular (RV) lead the patient experienced severe hypotension and major cardiac tamponade was identified. A pericardial drain was placed and the patient was intubated and was flown to a different facility where they underwent a median sternotomy and repair of RV injury. Dizziness, chest pain, pericardial effusion, and shortness of breath were also noted. The patient was hospitalized and the lead was programmed off. No further patient complications have been reported as a result of this event.
Patient problems: Cardiac Tamponade; Chest Pain; Dizziness; Dyspnea; Low Blood Pressure/ Hypotension; Pericardial Effusion
MAUDE report 50482429 ↗MalfunctionAug 26, 2026High impedance; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458085 ↗MalfunctionAug 25, 2026Failure to Capture; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440611 ↗MalfunctionAug 24, 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 50412936 ↗InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had redness, swelling and wound dehiscence. The Implantable Cardioverter Defibrillator (ICD) system was explanted due to wound dehiscence and visualization of the device through the opening of the incision approximately two months post implant. Cultures were sent to the lab. No further patient complications have been reported as a result of this event.
Patient problems: Erosion; Erythema; Swelling/ Edema; Wound Dehiscence
MAUDE report 50380143 ↗InjuryAug 21, 2026Signal Artifact/Noise; High impedance; Over-Sensing; High Capture Threshold
It was reported that oversensing of non-physiologic intervals and noise was observed on the Right Ventricular (RV) lead. Reprogramming was done to turn off the lead and to turn off detection therapies. The RV lead was subsequently 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 50375612 ↗MalfunctionAug 20, 2026Decreased Sensitivity
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358918 ↗MalfunctionAug 20, 2026Appropriate Device Problem Term/Code Not Available
It was reported by a patient representative that the patient heard an alert tone from their Cardiac Resynchronization Therapy Defibrillator (CRT-D) about four times a day for the last week or two, which was indicative of a Right Ventricular (RV) lead issue. 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 50345784 ↗
Other permanent pacemaker Electrode devices
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · permanent pacemaker Electrode136 deaths16,004 reports
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page