Sprint Quattro Secure S MRI™ SureScan™ 6935M55 (UDI 00643169356559)Recalls & reported problems
Medtronic, Inc. · LEAD 6935M55 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 defibrillator lead is implanted in the heart. Reports mostly describe the lead picking up false signals, high electrical resistance, alarms, and suspected fractures that led to removal or replacement. There are 7,694 reports, including 116 deaths and 4,289 injuries. 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
- 7,750
- Deaths reported
- 116
- Injuries reported
- 4,317
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7,750 adverse event reports that list this exact device (DI 00643169356559), received between Apr 8, 2016 and Sep 30, 2026 — classified as 116 deaths, 4,317 injuries, 3,317 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (2,859 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-Sensing2,859
- Adverse Event Without Identified Device or Use Problem1,441
- High impedance1,071
- High Capture Threshold796
- Impedance Problem795
- Under-Sensing756
- Signal Artifact/Noise739
- Fracture656
Patient problems
- No Clinical Signs, Symptoms or Conditions4,169
- No Known Impact Or Consequence To Patient1,083
- Unspecified Infection979
- Shock from Patient Lead(s)301
- No Consequences Or Impact To Patient263
- Pain102
- Chest Pain98
- Erythema92
Recent adverse event reports
The 25 most recent of 7,750 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952133 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950974 ↗InjurySep 30, 2026Failure to Capture; High impedance; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949809 ↗InjurySep 30, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Unstable Impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949141 ↗InjurySep 30, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Low impedance; Impedance Problem
It was reported that the Right Ventricular (RV) lead exhibited undefined high pacing impedance, low pacing impedance, impedance spikes, and noise. A Lead Integrity Alert (LIA) was triggered for incrementing Sensing Integrity Counter (SIC). The RV lead is suspected to be fractured on the low-voltage portion. Reprogramming was performed and 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 50946572 ↗MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing; Unstable Impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941559 ↗MalfunctionSep 29, 2026Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938349 ↗InjurySep 29, 2026Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation
It was reported that the T-Wave Oversensing (TWOS) was observed from the Right Ventricular (RV) lead resulting in false Ventricular Fibrillation (VF) detection and inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy. The patient also experienced discomfort and chest pain following inappropriate therapy. It was noted that the patient was hyperkalemic resulting in larger T waves. The RV lead was reprogrammed and remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Chest Pain; Discomfort; Shock from Patient Lead(s)
MAUDE report 50937426 ↗MalfunctionSep 29, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Under-Sensing; Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936384 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Twiddlers Syndrome
MAUDE report 50935936 ↗InjurySep 28, 2026Fracture; Inappropriate/Inadequate Shock/Stimulation
Patient problems: Shock from Patient Lead(s)
MAUDE report 50924685 ↗InjurySep 28, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
Patient problems: Shock from Patient Lead(s)
MAUDE report 50923523 ↗MalfunctionSep 28, 2026High impedance
It was reported that the Right Ventricular (RV) lead triggered multiple alerts for high RV defibrillation impedance. The Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times. The 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 50921612 ↗MalfunctionSep 28, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918140 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient reported discomfort/pain and the Implantable Cardioverter Defibrillator (ICD) device system was explanted due to an infection. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 50916201 ↗InjurySep 25, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904940 ↗MalfunctionSep 25, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900756 ↗InjurySep 25, 2026Signal Artifact/Noise; Over-Sensing; Low impedance
It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to an increase in Sensing Integrity Counter (SIC) with oversensing of noise and low defibrillation impedances. Reprogramming was done 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 50899767 ↗MalfunctionSep 25, 2026Capturing Problem
It was reported that the Left Ventricular (LV) lead and Right Ventricular (RV) lead exhibited rising pacing thresholds. The leads re main in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899323 ↗InjurySep 24, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886324 ↗MalfunctionSep 24, 2026Failure to Capture
It was reported that there was a concern for loss of capture as there were no paced beats on the transmission, but all measurements were within expected range. It was reported that the issue was resolved. 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 50886205 ↗MalfunctionSep 24, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885860 ↗MalfunctionSep 24, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) post ventricular sensing. 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 50883326 ↗InjurySep 24, 2026High impedance
It was reported that the Right Ventricular (RV) lead was explanted and replaced due to High RV Pacing Impedance. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882750 ↗MalfunctionSep 23, 2026Low impedance; High Capture Threshold
It was reported that the Right Ventricular (RV) lead pacing impedance intermittently drops below the threshold since the time the patient had a Ventricular Assist Device (VAD) implanted. The lead also 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 50871451 ↗
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
- 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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