Sprint Quattro Secure S® 6935M49 (UDI 00643169550889)Recalls & reported problems

Medtronic, Inc. · LEAD 6935M49 US DF4 NG ACI · 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 00643169550889), received between Apr 6, 2017 and Nov 13, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (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

Over-Sensing3
Fracture2
Defective Device1
High impedance1
Impedance Problem1
Inappropriate/Inadequate Shock/Stimulation1
Low impedance1

Patient problems

No Known Impact Or Consequence To Patient3
No Clinical Signs, Symptoms or Conditions1
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.

InjuryNov 13, 2023Fracture; Over-Sensing; Impedance Problem; Fracture; Over-Sensing; Impedance Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO BE FRACTURED AT THE LOW VOLTAGE PORTION OF THE LEAD AND TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). ADDITIONALLY, THE LEAD DISPLAYED A SPIKE IN PACING IMPEDANCE. THE 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 18120951 ↗
MalfunctionMar 31, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS T-WAVE OVERSENSING (TWOS) POST VENTRICULAR PACING. 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; Shock from Patient Lead(s)
MAUDE report 9907590 ↗
InjuryJun 25, 2018Fracture; High impedance; Over-Sensing; Low impedance; Fracture; High impedance; Over-Sensing; Low impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED DUE TO SENSING INTEGRITY COUNTER (SIC) AND A HIGH IMPEDANCE. IT WAS ALSO NOTED THERE WAS A PACING IMPEDANCE MEASUREMENT OF 0. A FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7634559 ↗
MalfunctionApr 6, 2017Defective Device; Defective Device
IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD WAS NEVER USED DUE TO ITS SHAPE. THE PHYSICIAN NOTED THAT THERE WAS A CURVE AT THE PROXIMAL END OF THE COIL AND NEAR THE CONNECTOR SLEEVE WITHOUT THE USE OF A STYLET. THE LEAD WAS NEVER USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6470703 ↗

Device details

UDI-DI	`00643169550889`
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	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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