Quattrode™ 3166 (UDI 05414734406109)Recalls & reported problems
St. Jude Medical, Inc. · Lead Wide Spaced, 60 cm · Class 2 · Implant
Quick summary
This St. Jude Medical Quattrode spinal cord stimulator lead is used for pain relief. Reports often describe pain relief being ineffective, along with leads migrating, high electrical resistance and fractures, and some mention surgery to reposition or remove leads. The 590 reports include injuries and no deaths. 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
- 594
- Deaths reported
- 0
- Injuries reported
- 594
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 594 adverse event reports that list this exact device (DI 05414734406109), received between Jun 19, 2018 and Sep 22, 2026 — classified as 594 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (130 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 Problem290
- Therapeutic or Diagnostic Output Failure130
- High impedance73
- Migration54
- Fracture29
- Impedance Problem16
- Failure to Deliver Energy11
- Inappropriate/Inadequate Shock/Stimulation10
Patient problems
- Inadequate Pain Relief355
- Erosion37
- Implant Pain28
- Pain28
- No Clinical Signs, Symptoms or Conditions26
- Discomfort24
- Post Operative Wound Infection23
- Unspecified Infection21
Recent adverse event reports
The 25 most recent of 594 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Migration
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: Inadequate Pain Relief
MAUDE report 50860383 ↗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 50846752 ↗InjurySep 16, 2026High impedance
It was reported that the patient experienced ineffective therapy. Troubleshooting revealed high impedances on the leads. 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 50793875 ↗InjurySep 16, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50793873 ↗InjurySep 16, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50793861 ↗InjuryAug 18, 2026High impedance
It was reported that the patient experienced ineffective therapy. Troubleshooting reveled high impedances on all leads. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50311741 ↗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 25862050 ↗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 25862045 ↗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 25862036 ↗InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENTS OCCIPITAL LEAD INCISION SITE WAS NOT HEALING PROPERLY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE OCCIPITAL LEADS AND ANCHORS WERE EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Wound Dehiscence
MAUDE report 25588230 ↗InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENTS OCCIPITAL LEAD INCISION SITE WAS NOT HEALING PROPERLY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE OCCIPITAL LEADS AND ANCHORS WERE EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Wound Dehiscence
MAUDE report 25588226 ↗InjuryJun 15, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF ONE OF THE SUPRAORBITAL LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPOSITIONED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH SUPRAORBITAL LEAD MIGRATED.
Patient problems: Inadequate Pain Relief
MAUDE report 25512536 ↗InjuryJun 14, 2026Use of Device Problem
IT WAS REPORTED THAT DURING THE PATIENT'S SYSTEM EXPLANT THE LEADS WERE CUT AND THEN LEFT IMPLANTED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 25497869 ↗InjuryJun 14, 2026Use of Device Problem
IT WAS REPORTED THAT DURING THE PATIENT'S SYSTEM EXPLANT THE LEADS WERE CUT AND THEN LEFT IMPLANTED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 25497864 ↗InjuryApr 23, 2026Failure to Deliver Energy
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO AUTO-REDUCING. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN TWO NEW LEADS WERE PLACED, AND THE EXISTING LEADS WERE UNABLE TO BE EXPLANTED [RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-01965].
Patient problems: Inadequate Pain Relief
MAUDE report 24971456 ↗InjuryApr 15, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVELED HIGH IMPEDANCES ON BOTH OCCIPITAL LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE OCCIPITAL LEADS WERE REPLACED. DURING SURGERY, X-RAY IMAGING REVEALED BOTH SUPRA-ORBITAL LEADS WERE ACCIDENTALLY PULLED. AS A RESULT, THE SUPRA-ORBITAL LEADS WERE REPOSITIONED DURING THAT PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 24885873 ↗InjuryApr 15, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVELED HIGH IMPEDANCES ON BOTH OCCIPITAL LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE OCCIPITAL LEADS WERE REPLACED. DURING SURGERY, X-RAY IMAGING REVEALED BOTH SUPRA-ORBITAL LEADS WERE ACCIDENTALLY PULLED. AS A RESULT, THE SUPRA-ORBITAL LEADS WERE REPOSITIONED DURING THAT PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 24885802 ↗InjuryApr 15, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVELED HIGH IMPEDANCES ON BOTH OCCIPITAL LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE OCCIPITAL LEADS WERE REPLACED. DURING SURGERY, X-RAY IMAGING REVEALED BOTH SUPRA-ORBITAL LEADS WERE ACCIDENTALLY PULLED. AS A RESULT, THE SUPRA-ORBITAL LEADS WERE REPOSITIONED DURING THAT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885790 ↗InjuryApr 15, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVELED HIGH IMPEDANCES ON BOTH OCCIPITAL LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE OCCIPITAL LEADS WERE REPLACED. DURING SURGERY, X-RAY IMAGING REVEALED BOTH SUPRA-ORBITAL LEADS WERE ACCIDENTALLY PULLED. AS A RESULT, THE SUPRA-ORBITAL LEADS WERE REPOSITIONED DURING THAT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885789 ↗InjuryMar 30, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN PATIENTS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24734971 ↗InjuryMar 30, 2026Failure to Deliver Energy
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO AUTO REDUCING ON ONE LEAD DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED. NOTE: IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24719880 ↗InjuryMar 16, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED INEFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 24607799 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT EXPERIENCED SWELLING AT THE SITE OF THEIR LEADS AND DRAINAGE DUE TO OPEN WOUNDS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS.
Patient problems: Swelling/ Edema
MAUDE report 24525923 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT EXPERIENCED SWELLING AT THE SITE OF THEIR LEADS AND DRAINAGE DUE TO OPEN WOUNDS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS.
Patient problems: Swelling/ Edema
MAUDE report 24525888 ↗InjuryJan 28, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED PATIENT EXPERIENCE DISCOMFORT AT THE SUPRA-ORBITAL LEAD SITES EVEN WHEN STIMULATION WAS OFF. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Undesired Nerve Stimulation
MAUDE report 24206324 ↗
Other STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) devices
- Octrode™ 3086St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)30 deaths1,538 reports
- Swift-Lock™ 1192St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)215 reports
- NA 3386St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)154 reports
- NA 3346St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)117 reports
- Quattrode® 3163St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)81 reports
- Quattrode™ 3163St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)52 reports
- Freedom-8A Receiver Kit Channel A US w/ Receiver FR8A-RCV-A0Stimwave Technologies Incorporated · Stimulator, Spinal-Cord, Implanted (Pain Relief)1 death52 reports
- Freedom System Accessories PDBT-915-2KCuronix LLC · Stimulator, Spinal-Cord, Implanted (Pain Relief)34 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.