Sprint Quattro Secure S® 6935M49 (UDI 00613994808004)Recalls & reported problems

Medtronic, Inc. · LEAD 6935M49 DF4 ACTIVE SC US EN · Class 3 · Implant

All models of Medtronic Sprint Quattro Lead (67) · Sprint Quattro Secure S (19)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994808004), received between Oct 25, 2017 and Dec 22, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture3
High impedance3
Over-Sensing3
Signal Artifact/Noise3
Impedance Problem1
Inappropriate/Inadequate Shock/Stimulation1

Patient problems

No Known Impact Or Consequence To Patient2
No Clinical Signs, Symptoms or Conditions1
Obstruction/Occlusion1
Shock from Patient Lead(s)1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

InjuryDec 22, 2023Fracture; Fracture
IT WAS FURTHER REPORTED THAT THE RV WAS NOT EXPLANTED DURING THE PROCEDURE. THE LEAD REMAINS IMPLANTED IN THE PATIENT.
Patient problems: Obstruction/Occlusion
MAUDE report 18382941 ↗
InjuryMay 19, 2023Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER HEARING AN AUDIBLE ALERT. AN INTERROGATION SHOWED THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC), AND ALERTS WERE ALSO TRIGGERED FOR HIGH UNDEFINED OUT OF RANGE (OOR) PACING IMPEDANCES. OVERSENSING OF NOISE WAS ALSO NOTED. THE LEAD WAS LATER EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16964409 ↗
MalfunctionOct 23, 2018Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem
IT WAS FURTHER REPORTED THAT THE LEAD WAS REPROGRAMMED AND REMAINS IN USE.
Patient problems: No Known Impact Or Consequence To Patient; Shock from Patient Lead(s)
MAUDE report 7995327 ↗
MalfunctionOct 25, 2017Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing
IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) WITH INCREASED SENSING INTEGRITY COUNTER (SIC) AND OVERSENSING NOISE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6976350 ↗

Device details

UDI-DI	`00613994808004`
Brand	Sprint Quattro Secure S®
Model	6935M49
Company	Medtronic, Inc.
Product code	NVY · Permanent defibrillator electrodes
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	May 6, 2024

Device type (GMDN): Endocardial defibrillation lead

An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

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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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