Sprint Quattro Secure S™ DXAC/DSP 693552 (UDI 00613994446084)Recalls & reported problems

Medtronic, Inc. · LEAD 693552 US EN SI MCRD · Class 3 · Implant

All models of Medtronic Sprint Quattro Lead (67) · Sprint Quattro Secure S DXAC/DSP (10)

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

Adverse event reports: 7
Deaths reported: 0
Injuries reported: 5
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994446084), received between Mar 16, 2017 and Aug 7, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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

Fracture4
High impedance4
Inappropriate/Inadequate Shock/Stimulation2
Signal Artifact/Noise2
Adverse Event Without Identified Device or Use Problem1
Impedance Problem1
Low impedance1
Over-Sensing1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Known Impact Or Consequence To Patient2
Shock from Patient Lead(s)2
Bacteremia1
Unspecified Infection1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT EXPERIENCED BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Bacteremia; Unspecified Infection
MAUDE report 22738099 ↗
InjurySep 8, 2021Fracture; Fracture
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE FRACTURE. 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 12439411 ↗
MalfunctionAug 9, 2021High impedance; Impedance Problem; High impedance; Impedance Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR A HIGH IMPEDANCE SPIKE ON THE RV COIL. THE LEAD ALERT WAS RESET. 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 12295950 ↗
InjuryAug 19, 2019Fracture; High impedance; Fracture; High impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED TWO HIGH IMPEDANCE MEASUREMENTS. A LEAD FRACTURE WAS SUSPECTED, AND 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 8906087 ↗
InjuryOct 31, 2018Signal Artifact/Noise; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO NOISE AND A CONFIRMED FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD HAD HIGH AND UNDEFINED IMPEDANCE MEASUREMENTS. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH IMPEDANCE MEASUREMENTS. THE RV LEAD WAS EXPLANTED AND REPLACED. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 8025391 ↗
MalfunctionApr 25, 2018Low impedance; Low impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR LOW PACING IMPEDANCE. THE IMPEDANCE ALERT WAS PROGRAMMED OFF AND 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 7461569 ↗
InjuryMar 16, 2017Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. IT WAS ALSO REPORTED THERE WAS A DEVICE SENSING AND DETECTION PROBLEM AND THE LEAD NOISE ALGORITHM AND T WAVE OVER-SENSING ALGORITHM DID NOT PREVENT THE SHOCK. ADDITIONALLY, THE LEAD DISPLAYED HIGH IMPEDANCE, OVER-SENSING, NOISE AND WAS FRACTURED. IT WAS STATED THE NOISE FROM THE LEAD ¿CAUSED THE SHOCK.¿ RE-PROGRAMMING TO TURN THE DEVICE ¿OFF¿ WAS DONE. A LIFE VEST WAS PLACED ON THE PATIENT AND FOLLOWING, THE DEVICE AND LEAD WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 6411180 ↗

Device details

UDI-DI	`00613994446084`
Brand	Sprint Quattro Secure S™ DXAC/DSP
Model	693552
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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