Quattrode™ 3146 (UDI 05415067017321)Recalls & reported problems
St. Jude Medical, Inc. · Lead, 3/4mm, 60 cm · Class 3 · Implant
Quick summary
This Quattrode 3146 lead is a thin wire lead used with a fully implanted spinal cord stimulator for pain relief. The 57 reports mostly describe leads that stopped delivering effective stimulation, with high impedance readings, leads that shifted position or broke, and patients who still had pain despite the device; several describe surgery to remove, replace, or add leads. There are 57 injuries and no deaths, and 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
- 57
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 05415067017321), received between Aug 23, 2018 and May 17, 2026 — classified as 57 injuries.
The most frequently reported specific device problem is “High impedance” (24 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 impedance24
- Adverse Event Without Identified Device or Use Problem10
- Therapeutic or Diagnostic Output Failure10
- Migration5
- Fracture4
- Impedance Problem3
- Insufficient Device Problem Information3
- No Apparent Adverse Event3
Patient problems
- Inadequate Pain Relief44
- Discomfort3
- Device Overstimulation of Tissue2
- Erosion2
- Implant Pain2
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- Unspecified Infection2
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2026High impedance
IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THEIR LEADS. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25196490 ↗InjuryMay 17, 2026High impedance
IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THEIR LEADS. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25196489 ↗InjuryAug 18, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH LEADS WERE EXPLANTED TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT ASSOCIATED WITH THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22829188 ↗InjuryJun 19, 2025Impedance Problem; Impedance Problem
IT WAS REPORTED THAT THE PATIENT HAS INEFFECTIVE THERAPY DUE TO INVALID IMPEDANCES ON THEIR LEAD. SURGICAL INTERVENTION MAY BE PENDING AT A LATER DATE TO ADDRESS THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22289824 ↗InjuryJan 3, 2024Migration; Migration
RELATED MANUFACTURER REPORT NUMBER: 1627487-2024-00024. IT WAS REPORTED THAT BOTH OF THE PATIENT'S LEADS MIGRATED. THE PATIENT DID NOT REPORT ANY FALLS OR TRAUMAS. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE LEADS. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 18440718 ↗InjuryAug 24, 2023Therapeutic or Diagnostic Output Failure; No Apparent Adverse Event; Therapeutic or Diagnostic Output Failure; No Apparent Adverse Event
ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT DOES NOT HAVE INEFFECTIVE STIMULATION AND THEREFORE THIS IS NO LONGER REPORTABLE.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 17618935 ↗InjuryAug 10, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER:1627487-2023-03723. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DIE TO HIGH IMPEDANCE ON THE LEADS. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN PLACE ON THE (B)(6)2023 WHERE THE LEADS WERE ATTEMPTED TO BE REPLACED BUT WERE UNABLE TO BE REMOVED. THEREFORE, TWO NEW LEADS WERE ADDED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 17496137 ↗InjuryAug 10, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER:1627487-2023-03724. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DIE TO HIGH IMPEDANCE ON THE LEADS. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN PLACE ON THE (B)(6) 2023 WHERE THE LEADS WERE ATTEMPTED TO BE REPLACED BUT WERE UNABLE TO BE REMOVED. THEREFORE, TWO NEW LEADS WERE ADDED "TO" ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 17496136 ↗InjuryJul 17, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER:1627487-2023-03338. RELATED MANUFACTURER REPORT NUMBER:1627487-2023-03340. IT WAS REPORTED THAT THE PATIENT'S IPG HAD REACHED END OF LIFE. THE PATIENT'S PERIPHERAL LEADS WERE ALSO NOTED TO HAVE HIGH IMPEDANCE AND THE PATIENT HAD NOT BEEN EXPERIENCING EFFECTIVE RELIEF. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE PATIENT'S SCS SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 17337105 ↗InjuryJul 17, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER:1627487-2023-03338. RELATED MANUFACTURER REPORT NUMBER:1627487-2023-03339. IT WAS REPORTED THAT THE PATIENT'S IPG HAD REACHED END OF LIFE. THE PATIENT'S PERIPHERAL LEADS WERE ALSO NOTED TO HAVE HIGH IMPEDANCE AND THE PATIENT HAD NOT BEEN EXPERIENCING EFFECTIVE RELIEF. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(4) 2023 WHEREIN THE PATIENT'S SCS SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 17337071 ↗InjuryJun 6, 2023High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AND WAS UNABLE TO PLACE THEIR SYSTEM INTO MRI MODE. TROUBLESHOOTING REVEALED MULTIPLE HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN TO ADDRESS THE ISSUE AND THE SYSTEM WAS EXPLANTED AND REPLACED ON (B)(6) 2023. IT IS UNKNOWN WHICH LEAD HAS HIGH IMPEDANCE.
Patient problems: Inadequate Pain Relief
MAUDE report 17072121 ↗InjuryFeb 5, 2023Fracture; Fracture
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-00474. IT WAS REPORTED THAT THE PATIENT'S CERVICAL LEADS WERE EXPLANTED AND REPLACED DUE TO A FRACTURE. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 16301976 ↗InjuryFeb 5, 2023Fracture; Fracture
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-00473. IT WAS REPORTED THAT THE PATIENT'S CERVICAL LEADS WERE EXPLANTED AND REPLACED DUE TO A FRACTURE. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 16301975 ↗InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00405, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00406. IT WAS REPORTED THAT THE PATIENT'S IPG HAS BECOME INOPERABLE AND THAT THE PATIENT EXPERIENCED PAIN AT THEIR ILIAC CREST WHERE THE LEADS WERE PERIPHERALLY PLACED. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2023 DURING WHICH THE IPG WAS EXPLANTED AND REPLACED AND THE TWO QUATTRODE LEADS AND EXTENSION WERE EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 16263993 ↗InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00407, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00406. IT WAS REPORTED THAT THE PATIENT'S IPG HAS BECOME INOPERABLE AND THAT THE PATIENT EXPERIENCED PAIN AT THEIR ILIAC CREST WHERE THE LEADS WERE PERIPHERALLY PLACED. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2023 DURING WHICH THE IPG WAS EXPLANTED AND REPLACED AND THE TWO QUATTRODE LEADS AND EXTENSION WERE EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 16263977 ↗InjuryOct 29, 2022High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBERS: 3006705815-2022-15348; 3006705815-2022-15349. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. HIGH IMPEDANCES WERE MEASURED ON 1 OF 2 THORACIC LEADS AND ON BOTH CERVICAL LEADS. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH THORACIC LEAD HAD HIGH IMPEDANCES. THEREFORE BOTH LEADS ARE BEING REPORTED.
Patient problems: Inadequate Pain Relief
MAUDE report 15697306 ↗InjuryOct 29, 2022High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBERS: 3006705815-2022-15348; 3006705815-2022-15349; 1627487-2022-05866. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. HIGH IMPEDANCES WERE MEASURED ON 1 OF 2 THORACIC LEADS AND ON BOTH CERVICAL LEADS. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH THORACIC LEAD HAD HIGH IMPEDANCES. THEREFORE BOTH LEADS ARE BEING REPORTED.
Patient problems: Inadequate Pain Relief
MAUDE report 15697305 ↗InjurySep 19, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-04780, 3006705815-2022-16514. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15451854 ↗InjurySep 19, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-16514, 1627487-2022-04781. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15451853 ↗InjuryJul 19, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03767. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03768. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03769. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15053581 ↗InjuryJul 19, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER:1627487-2022-03766, RELATED MANUFACTURER REFERENCE NUMBER:1627487-2022-03768, RELATED MANUFACTURER REFERENCE NUMBER:1627487-2022-03769. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15053579 ↗InjuryJun 9, 2022High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-03263. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-03265. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-03266. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AFTER A FALL. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON ALL LEAD CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 14640443 ↗InjuryJun 8, 2022High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2022-03262, 1627487-2022-03263, 1627487-2022-03266. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AFTER A FALL. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON ALL LEAD CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 14640302 ↗InjuryJun 8, 2022High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2022-03262, 1627487-2022-03266, 1627487-2022-03265. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AFTER A FALL. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON ALL LEAD CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 14640239 ↗InjuryApr 27, 2022Migration; Migration
RELATED MANUFACTURER REPORT NUMBER 1627487-2022-02420. IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS HAD MIGRATED. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 WHEREIN THE LEAD WAS REPOSITIONED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY. NOTE: AS IT IS UNKNOWN WHICH LEAD HAD MIGRATED, BOTH LEADS ARE BEING REPORTED.
Patient problems: Inadequate Pain Relief
MAUDE report 14223162 ↗
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-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-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-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-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-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-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-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-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.