Quattrode™ 3156 (UDI 05414734401623)Recalls & reported problems
St. Jude Medical, Inc. · Lead, 3/6mm, 60 cm · Class 3 · Implant
Quick summary
This St. Jude Medical Quattrode lead is an implanted wire used in spinal cord stimulators for pain relief. The 47 reports mostly describe leads that stop working well, with high impedance readings, leads that shift position or break, and leads that come through the skin; all47 involve injuries and none resulted in death. In several cases the stimulator gave no effective pain relief, and surgery was needed to remove or replace 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
- 46
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 05414734401623), received between Apr 4, 2019 and Sep 16, 2026 — classified as 46 injuries.
The most frequently reported specific device problem is “High impedance” (13 reports).
14 other recalls cover devices cleared under the same FDA submission (P010032); they may or may not involve this specific model.
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
- High impedance13
- Therapeutic or Diagnostic Output Failure13
- Migration11
- Fracture7
- Adverse Event Without Identified Device or Use Problem5
- Insufficient Device Problem Information4
- No Apparent Adverse Event2
- Battery Problem1
Patient problems
- Inadequate Pain Relief39
- Failure of Implant3
- Erosion2
- Insufficient Information2
- No Consequences Or Impact To Patient2
- No Information2
- Post Operative Wound Infection2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026High impedance
It was reported that the patient's leads exhibited high impedances. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790613 ↗InjuryNov 19, 2025High impedance; High impedance
ADDITIONAL INFORMATION INDICATES THAT AFTER A ROUTINE IPG REPLACEMENT, EFFECTIVE THERAPY WAS RESTORED POSTOPERATIVELY AND INTERVENTION IS NO LONGER PLANNED TO REPLACE THE LEADS.
Patient problems: Inadequate Pain Relief
MAUDE report 23597672 ↗InjuryNov 19, 2025High impedance; High impedance
ADDITIONAL INFORMATION INDICATES THAT AFTER A ROUTINE IPG REPLACEMENT, EFFECTIVE THERAPY WAS RESTORED POSTOPERATIVELY AND INTERVENTION IS NO LONGER PLANNED TO REPLACE THE LEADS.
Patient problems: Inadequate Pain Relief
MAUDE report 23597668 ↗InjuryNov 19, 2025High impedance; High impedance
ADDITIONAL INFORMATION INDICATES THAT AFTER A ROUTINE IPG REPLACEMENT, EFFECTIVE THERAPY WAS RESTORED POSTOPERATIVELY AND INTERVENTION IS NO LONGER PLANNED TO REPLACE THE LEADS.
Patient problems: Inadequate Pain Relief
MAUDE report 23597661 ↗InjuryOct 24, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND THE IPG WAS UNABLE TO COMMUNICATE WITH THE EXTERNAL DEVICES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23377999 ↗InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS INITIALLY REPORTED THAT THE PATIENT WAS TO UNDERGO SURGICAL INTERVENTION OF AN EXPLANT DUE TO AN INFECTION. UPON FURTHER INVESTIGATION, ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO INFECTION, BUT THE PATIENT'S OCCIPITAL LEADS ERODED THROUGH THE SKIN. SURGICAL INTERVENTION TOOK PLACE WHERE THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE, THE PATIENT'S' WOUND HAS FULLY HEALED.
Patient problems: Erosion
MAUDE report 21260253 ↗InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS INITIALLY REPORTED THAT THE PATIENT WAS TO UNDERGO SURGICAL INTERVENTION OF AN EXPLANT DUE TO AN INFECTION. UPON FURTHER INVESTIGATION, ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO INFECTION, BUT THE PATIENT'S OCCIPITAL LEADS ERODED THROUGH THE SKIN. SURGICAL INTERVENTION TOOK PLACE WHERE THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE, THE PATIENT'S' WOUND HAS FULLY HEALED.
Patient problems: Erosion
MAUDE report 21260204 ↗InjuryOct 18, 2024High impedance; High impedance
IT WAS REPORTED THAT BOTH OF THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH THEIR QUATTRODE LEADS. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADDRESS THE ISSUE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE PATIENT'S OCTRODE LEAD WAS FRACTURED. IN TURN, ALL 3 LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 20483501 ↗InjuryOct 18, 2024High impedance; High impedance
IT WAS REPORTED THAT BOTH OF THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH THEIR QUATTRODE LEADS. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADDRESS THE ISSUE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE PATIENT'S OCTRODE LEAD WAS FRACTURED. IN TURN, ALL 3 LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 20483494 ↗InjuryDec 3, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO A FRACTURED L3 LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 18253550 ↗InjuryJun 12, 2023Battery Problem; Insufficient Device Problem Information; Migration; Battery Problem; Insufficient Device Problem Information; Migration
IT WAS REPORTED THAT THE PATIENT'S IPG HAD DIED. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. SURGICAL INTERVENTION OCCURRED ON (B)(6) 2023 DURING WHICH THE IPG WAS EXPLANTED AND REPLACED AND TWO NEW LEADS WERE IMPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief; Insufficient Information
MAUDE report 17110743 ↗InjuryMay 12, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER 1627487-2023-02170. IT WAS REPORTED THAT PATIENT 'S IPG WAS AT END OF LIFE AND HER LEAD HAD HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG, AND LEAD WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 16924135 ↗InjuryApr 12, 2023High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-01626, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-01724. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCE RESULTING IN INEFFECTIVE THERAPY AND THE IPG WAS ELECTIVELY REPLACED. REPORTEDLY, EFFECTIVE THERAPY WAS ACHIEVED POST OP.
Patient problems: Inadequate Pain Relief; Insufficient Information
MAUDE report 16728494 ↗InjuryJun 14, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03377 , 1627487-2022-03378 , 1627487-2022-03379. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. X-RAYS INDICATED THE LEADS HAD MIGRATED. IN TURN, ALL FOUR LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 14685538 ↗InjuryJun 14, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03377 , 1627487-2022-03378 , 1627487-2022-03380. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. X-RAYS INDICATED THE LEADS HAD MIGRATED. IN TURN, ALL FOUR LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 14685527 ↗InjuryJun 14, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03378 , 1627487-2022-03379 , 1627487-2022-03380. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. X-RAYS INDICATED THE LEADS HAD MIGRATED. IN TURN, ALL FOUR LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 14685521 ↗InjuryJun 14, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03377 , 1627487-2022-03379 , 1627487-2022-03380. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. X-RAYS INDICATED THE LEADS HAD MIGRATED. IN TURN, ALL FOUR LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 14685394 ↗InjuryMay 15, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-02778, 1627487-2022-02779, AND 1627487-2022-02780. IT WAS REPORTED THAT THE PATIENT HAD A FALL IN (B)(6) 2022 AND LOST EFFECTIVE THERAPY. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED, RESOLVING THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 14404071 ↗InjuryMay 13, 2021Migration; Migration
ADDITIONAL INFORMATION RECEIVED INDICATED PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN BOTH THE LEADS WERE EXPLANTED AND REPLACED WITH NEW ONES. REPORTEDLY EFFECTIVE THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 11820483 ↗InjuryMay 13, 2021Migration; Migration
ADDITIONAL INFORMATION RECEIVED INDICATED PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN BOTH THE LEADS WERE EXPLANTED AND REPLACED WITH NEW ONES. REPORTEDLY EFFECTIVE THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 11820473 ↗InjuryMar 14, 2021Fracture; High impedance; Fracture; High impedance
IT WAS REPORTED THAT THE PATIENT LOST THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON THE ENTIRE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. ISSUE RESOLVED.
Patient problems: Inadequate Pain Relief
MAUDE report 11479012 ↗InjuryMar 8, 2021Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-01831. IT WAS REPORTED THAT THE PATIENT'S TWO SUPRAORBITAL LEADS MIGRATED. AS A RESULT, SURGERY TOOK PLACE WHEREIN THE MIGRATED LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 11435441 ↗InjuryMar 8, 2021Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-01830. IT WAS REPORTED THAT THE PATIENT'S TWO SUPRAORBITAL LEADS MIGRATED. AS A RESULT, SURGERY TOOK PLACE WHEREIN THE MIGRATED LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 11435425 ↗InjuryFeb 5, 2021Migration; Migration
RELATED MANUFACTURING NUMBERS: 1627487-2021-00948, 1627487-2021-00950, 1627487-2021-00951. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON 24 FEB 2021, WHERE IN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 11289655 ↗InjuryFeb 5, 2021Migration; Migration
RELATED MANUFACTURING NUMBERS: 1627487-2021-00949, 1627487-2021-00950, 1627487-2021-00951. IT WAS REPORTED THAT THE PATIENTS LEADS HAVE MIGRATED, WHICH CAUSED INEFFECTIVE STIMULATION. IN TURN, THE PATIENT MAY UNDERGO SURGERY AT A LATER TIME TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 11289644 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P010032. One submission often covers many models, so check the product and lot details in each record.
- Z-0458-2026 · Oct 6, 2025 · Open, ClassifiedEterna SCS IPG (Implantable Pulse Generator), Model Number 32400
- Z-2505-2023 · Jul 18, 2023 · Open, ClassifiedProclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electr
- Z-2510-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
- Z-2508-2023 · Jul 18, 2023 · Open, ClassifiedProclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
- Z-2509-2023 · Jul 18, 2023 · Open, ClassifiedProclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extens
- Z-2507-2023 · Jul 18, 2023 · Open, ClassifiedProclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
- Z-2506-2023 · Jul 18, 2023 · Open, ClassifiedProclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device
- Z-2511-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
- Z-2692-2017 · Jun 2, 2017 · TerminatedProclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
- Z-2691-2017 · Jun 2, 2017 · TerminatedProclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
- Z-1785-2013 · Nov 30, 2012 · TerminatedEon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 reca
- Z-0025-2013 · Sep 4, 2012 · TerminatedThe Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode
- Z-1738-2013 · Jul 26, 2012 · TerminatedEon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or li
- Z-3091-2011 · Jun 2, 2009 · TerminatedSoftware version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting im
Other STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices
- Octrode™ 3186St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF30 deaths32,096 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths23,976 reports
- RestoreSensor™SureScan® 97714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 deaths17,903 reports
- Proclaim™ 3660St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls25 deaths13,336 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- Precision Spectra ™ SC-1132Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF53 deaths11,269 reports
- Proclaim™ 5 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall10 deaths9,661 reports
- Proclaim™ 7 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall12 deaths7,299 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.