Quattrode™ 3166 (UDI 05414734401661)Recalls & reported problems
St. Jude Medical, Inc. · Lead Wide Spaced, 60 cm · Class 2 · Implant
Quick summary
This St. Jude Medical Quattrode implanted nerve stimulator lead has 429 reports, all listed as injuries, and no deaths. Common problems described include pain relief failing, often because a lead moved out of position, and some patients needed surgery to reposition or remove the lead. 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
- 429
- Deaths reported
- 0
- Injuries reported
- 429
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 429 adverse event reports that list this exact device (DI 05414734401661), received between Jul 12, 2018 and Sep 28, 2026 — classified as 429 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (117 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem137
- Therapeutic or Diagnostic Output Failure117
- Migration65
- High impedance56
- Fracture23
- Inappropriate/Inadequate Shock/Stimulation23
- Insufficient Device Problem Information16
- Failure to Deliver Energy4
Patient problems
- Inadequate Pain Relief255
- Implant Pain54
- Undesired Nerve Stimulation26
- Erosion18
- No Consequences Or Impact To Patient17
- Unspecified Infection16
- No Clinical Signs, Symptoms or Conditions15
- Post Operative Wound Infection14
Recent adverse event reports
The 25 most recent of 429 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Migration
It was reported that the patient experienced ineffective therapy and headaches. X-ray imaging revealed migration of the Left Occipital lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was repositioned to address the issue.
Patient problems: Headache; Inadequate Pain Relief
MAUDE report 50917646 ↗InjurySep 24, 2026Migration
It was reported that the patient's lead migrated. X-ray imaging revealed migration of the left supraorbital lead migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was repositioned to address the issue.
Patient problems: Insufficient Information
MAUDE report 50888635 ↗InjurySep 22, 2026Use of Device Problem
It was reported that the patient's right Supra-orbital lead had migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was repositioned to address the issue. X-ray imaging revealed the right occipital lead was accidentally moved during the procedure. As a result, the patient returned to surgery on (b)(6) 2026 wherein the right occipital lead was repositioned to address the issue. Effective therapy was restored post operatively. It is unknown which leads were the right Supra-orbital and right occipital lead.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860382 ↗InjurySep 22, 2026Migration
It was reported that the patient experienced ineffective therapy. X-ray imaging revealed migration of the lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was repositioned to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50849947 ↗InjurySep 21, 2026Material Twisted/Bent
It was reported that following recent weight loss, the patient experienced pain at the IPG site. Additionally, the right Occipital lead migrated and bent and another lead migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was repositioned, the right Occipital lead was explanted and replaced, and the other lead was repositioned to address the issue. It is unknown which lead migrated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846748 ↗InjurySep 21, 2026Migration
It was reported that following recent weight loss, the patient experienced pain at the IPG site. Additionally, the right Occipital lead migrated and bent and another lead migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was repositioned, the right Occipital lead was explanted and replaced, and the other lead was repositioned to address the issue. It is unknown which lead migrated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846746 ↗InjurySep 16, 2026Migration
It was reported that the patient experienced ineffective therapy, the leads were uncomfortable and visible. X-ray imaging revealed migration of two leads. As a result, surgical intervention was undertaken wherein the system was explanted to address the issue.
Patient problems: Implant Pain; Inadequate Pain Relief
MAUDE report 50789583 ↗InjurySep 16, 2026Migration
It was reported that the patient experienced ineffective therapy, the leads were uncomfortable and visible. X-ray imaging revealed migration of two leads. As a result, surgical intervention was undertaken wherein the system was explanted to address the issue.
Patient problems: Implant Pain; Inadequate Pain Relief
MAUDE report 50789581 ↗InjuryAug 20, 2026Fracture
It was reported that the patient's lead exhibited high impedances. X-ray imaging revealed fracture of left supraorbital lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50355734 ↗InjuryAug 6, 2026Inappropriate/Inadequate Shock/Stimulation
It was reported that following a recent fall the patient experienced ineffective therapy and uncomfortable stimulation of the right supraorbital lead. Reprogramming has been unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue
Patient problems: Inadequate Pain Relief
MAUDE report 50166725 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following weight loss, the patient experienced skin erosion at the lead and extension sites. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Erosion
MAUDE report 50119165 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported patient underwent surgical intervention on (b)(6) 2026 wherein the right occipital lead was repositioned due to being superficial. Therapy was restored post-op.
Patient problems: Erosion
MAUDE report 50074399 ↗InjuryJul 28, 2026High impedance
It was reported that the patient experienced ineffective therapy following a jet-ski accident. Diagnostics revealed high impedances on all 4 leads. As a result, surgical intervention may be undertaken in the future.
Patient problems: Inadequate Pain Relief
MAUDE report 50063606 ↗InjuryJul 28, 2026High impedance
It was reported that the patient experienced ineffective therapy following a jet-ski accident. Diagnostics revealed high impedances on all 4 leads. As a result, surgical intervention may be undertaken in the future.
Patient problems: Inadequate Pain Relief
MAUDE report 50063600 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced skin erosion at the lead sites. As a result, surgical intervention was undertaken wherein the entire system was explanted on (b)(6) 2026 to address the issue.
Patient problems: Skin Erosion
MAUDE report 50060748 ↗InjuryJul 17, 2026Migration
IT WAS REPORTED THAT THE PATIENT'S IPG MIGRATED AND THE LEADS WERE PULLING AT THEIR NECK. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS REPOSITIONED, AND ALL LEADS WERE SUTURED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862052 ↗InjuryJul 8, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. VISUAL CONFIRMATION REVEALED THE LEFT SUPRA-ORBITAL LEAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPOSITIONED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 25748354 ↗InjuryJul 7, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO MIGRATION OF TWO LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN (B)(6) 2026 WHEREIN THE LEADS WERE REPOSITIONED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25736219 ↗InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT'S LEADS WIRES COMING ACROSS HER CLAVICLE CAUSING PATIENT PAIN. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 25683077 ↗InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT'S LEADS WIRES COMING ACROSS HER CLAVICLE CAUSING PATIENT PAIN. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 25682916 ↗InjuryJun 26, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN TO REPOSITION THE LEFT SUPRA-ORBITAL LEAD.
Patient problems: Inadequate Pain Relief
MAUDE report 25637752 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT AT THE LEAD SITES AND INEFFECTIVE STIMULATION THAT WAS NOT RESOLVED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE SYSTEM WAS REMOVED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 25465617 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG AND LEAD SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.
Patient problems: Implant Pain
MAUDE report 25461288 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG AND LEAD SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.
Patient problems: Implant Pain
MAUDE report 25461287 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG AND LEAD SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.
Patient problems: Implant Pain
MAUDE report 25461285 ↗
Other STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) devices
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- PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A STQ4-RCV-A0Curonix LLC · Stimulator, Peripheral Nerve, Implanted (Pain Relief)8 deaths364 reports
- Nalu Medical, Inc. 71019-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall225 reports
- StimQ Receiver Stimulator Kit Channel A US w/Receiver STQ4-RCV-A0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)3 deaths270 reports
- Nalu Medical, Inc. 71020-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)213 reports
- StimQ Spare Lead Kit Channel B US w/Receiver STQ4-SPR-B0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)126 reports
- Nalu Medical, Inc. 71005-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall73 reports
- Nalu Medical, Inc. 71020Nalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)101 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.