Quattrode™ 3066Recalls & reported problems

St. Jude Medical, Inc. · Trial Lead Wide Spaced · Class 2 · Implant

All models of Quattrode (17)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 8
Deaths reported: 0
Injuries reported: 8
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734406017), received between Jun 29, 2018 and Sep 10, 2018 — classified as 8 injuries.

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 16, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem8

Patient problems

Discomfort4
Muscle Stimulation4

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 1 OF 4 REFERENCE MFR. REPORT#: 1627487-2018-08582, 1627487-2018-08584, 1627487-2018-08586. FOLLOW UP REVEALED THAT THE PATIENT'S LEAD WAS EXPLANTED AND A NEW SCS SYSTEM WAS IMPLANTED, WHICH ADDRESSED THE ISSUE.
Patient problems: Discomfort
MAUDE report 7862449 ↗
InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 2 OF 4. REFERENCE MFR. REPORT#: 1627487-2018-08581, 1627487-2018-08582, 1627487-2018-08586. FOLLOW UP REVEALED THAT THE PATIENT'S LEAD WAS EXPLANTED AND A NEW SCS SYSTEM WAS IMPLANTED, WHICH ADDRESSED THE ISSUE.
Patient problems: Discomfort
MAUDE report 7862441 ↗
InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 2 OF 4 REFERENCE MFR. REPORT#: 1627487-2018-08581, 1627487-2018-08584, 1627487-2018-08586. FOLLOW UP REVEALED THAT THE PATIENT'S LEAD WAS EXPLANTED AND A NEW SCS SYSTEM WAS IMPLANTED, WHICH ADDRESSED THE ISSUE.
Patient problems: Discomfort
MAUDE report 7862378 ↗
InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 4 OF 4: REFERENCE MFR. REPORT#: 1627487-2018-08581, 1627487-2018-08582, 1627487-2018-08584. FOLLOW UP REVEALED THAT THE PATIENT'S LEAD WAS EXPLANTED AND A NEW SCS SYSTEM WAS IMPLANTED, WHICH ADDRESSED THE ISSUE.
Patient problems: Discomfort
MAUDE report 7862341 ↗
InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 4 OF 4. REFERENCE MFR REPORT#1627487-2018-05827, REFERENCE MFR REPORT#1627487-2018-05840, REFERENCE MFR REPORT#1627487-2018-05842. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE STIMULATION AFTER THE SUPRAORBITAL TRIAL LEADS WERE IMPLANTED. REPORTEDLY, PATIENT WENT TO SURGERY TO RE-POSITION THE LEADS AND IS EXPERIENCING ONLY MUSCLE STIMULATION FROM THE LEADS POST-OPERATIVELY. PATIENT HAD A FAILED TRIAL. INITIAL REPORTER INFORMATION (PATIENT) IS UNKNOWN AT THIS TIME.
Patient problems: Muscle Stimulation
MAUDE report 7652873 ↗
InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 3 OF 4. REFERENCE MFR REPORT#1627487-2018-05827, REFERENCE MFR REPORT#1627487-2018-05840, REFERENCE MFR REPORT#1627487-2018-05845. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE STIMULATION AFTER THE SUPRAORBITAL TRIAL LEADS WERE IMPLANTED. REPORTEDLY, PATIENT WENT TO SURGERY TO RE-POSITION THE LEADS AND IS EXPERIENCING ONLY MUSCLE STIMULATION FROM THE LEADS POST-OPERATIVELY. PATIENT HAD A FAILED TRIAL. INITIAL REPORTER INFORMATION (PATIENT) IS UNKNOWN AT THIS TIME.
Patient problems: Muscle Stimulation
MAUDE report 7652871 ↗
InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 2 OF 4 REFERENCE MFR REPORT#1627487-2018-05827 REFERENCE MFR REPORT#1627487-2018-05842 REFERENCE MFR REPORT#1627487-2018-05845 IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE STIMULATION AFTER THE SUPRAORBITAL TRIAL LEADS WERE IMPLANTED. REPORTEDLY, PATIENT WENT TO SURGERY TO RE-POSITION THE LEADS AND IS EXPERIENCING ONLY MUSCLE STIMULATION FROM THE LEADS POST-OPERATIVELY. PATIENT HAD A FAILED TRIAL. INITIAL REPORTER INFORMATION (PATIENT) IS UNKNOWN AT THIS TIME.
Patient problems: Muscle Stimulation
MAUDE report 7652860 ↗
InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 1 OF 4: REFERENCE MFR REPORT# 1627487-2018-05840; REFERENCE MFR REPORT# 1627487-2018-05842; REFERENCE MFR REPORT# 1627487-2018-05845. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE STIMULATION AFTER THE SUPRAORBITAL TRIAL LEADS WERE IMPLANTED. REPORTEDLY, PATIENT WENT TO SURGERY TO RE-POSITION THE LEADS AND IS EXPERIENCING ONLY MUSCLE STIMULATION FROM THE LEADS POST-OPERATIVELY. PATIENT HAD A FAILED TRIAL. INITIAL REPORTER INFORMATION (PATIENT) IS UNKNOWN AT THIS TIME.
Patient problems: Muscle Stimulation
MAUDE report 7652855 ↗

Device details

UDI-DI	`05414734406017`
Brand	Quattrode™
Model	3066
Company	St. Jude Medical, Inc.
Product code	GZF · STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
Class	Class 2
FDA submission	K072462, K960728
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	Dec 9, 2024

Device type (GMDN): Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.

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All STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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