Quattrode® 3146Recalls & reported problems
Advanced Neuromodulation Systems, Inc. · Lead, 3/4mm, 60 cm · Class 3 · Implant
All models of Quattrode (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Quattrode spinal-cord stimulation lead has 103 adverse event reports with no deaths and 103 injuries. Reports mostly describe ineffective therapy, with lead migration, high impedance, therapy output failure, and sometimes fracture; patients reported inadequate pain relief or unwanted nerve stimulation. Follow-up often involved surgery to reposition, explant, or replace leads. There are no recalls for 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
- 101
- Deaths reported
- 0
- Injuries reported
- 101
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 05414734401586), received between Jun 15, 2018 and Jun 10, 2026 — classified as 101 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Therapeutic or Diagnostic Output Failure24
- High impedance20
- Migration18
- Insufficient Device Problem Information16
- Adverse Event Without Identified Device or Use Problem14
- Fracture3
- Inappropriate/Inadequate Shock/Stimulation3
- Impedance Problem2
Patient problems
- Inadequate Pain Relief69
- No Clinical Signs, Symptoms or Conditions6
- Undesired Nerve Stimulation6
- No Consequences Or Impact To Patient5
- Implant Pain4
- Insufficient Information4
- No Known Impact Or Consequence To Patient4
- Failure of Implant2
Recent adverse event reports
The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF ONE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPOSITIONED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD MIGRATED.
Patient problems: Inadequate Pain Relief
MAUDE report 25460703 ↗InjuryMay 29, 2026Migration
IT WAS REPORTED THAT DURING A IPG REPLACEMENT PROCEDURE ON (B)(6) 2026, ONE OF THE QUATTRODE LEADS WAS VISUALLY CONFIRMED TO BE FRACTURED AND ANOTHER QUATTRODE LEAD HAD MIGRATED WHICH WAS CONFIRMED THROUGH X-RAY IMAGING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25331662 ↗InjuryMay 29, 2026Fracture
IT WAS REPORTED THAT DURING A IPG REPLACEMENT PROCEDURE ON (B)(6) 2026, ONE OF THE QUATTRODE LEADS WAS VISUALLY CONFIRMED TO BE FRACTURED AND ANOTHER QUATTRODE LEAD HAD MIGRATED WHICH WAS CONFIRMED THROUGH X-RAY IMAGING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25331609 ↗InjuryApr 23, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD ATTRIBUTED TO THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24975216 ↗InjuryMar 30, 2026Migration
IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS MIGRATED. IT IS UNKNOWN WHICH LEAD WAS AT FAULT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS REPOSITIONED TO RESOLVE THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24737507 ↗InjuryMar 9, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. STIMULATION WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 24546417 ↗InjuryMar 9, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. STIMULATION WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 24546413 ↗InjuryJan 26, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD TWO OF THEIR SYSTEM LEADS EXPLANTED IN 2022 FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24185381 ↗InjuryJan 26, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD TWO OF THEIR SYSTEM LEADS EXPLANTED IN 2022 FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24185372 ↗InjuryDec 11, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 23782672 ↗InjuryDec 11, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 23782641 ↗InjurySep 19, 2025High impedance; High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. IT WAS ALSO REPORTED THAT PATIENT HAS AN ACTIVE LIFESTYLE AND USES A RIDING LAWN MOWER. DIAGNOSTICS REVEALED THAT BOTH OF PATIENT'S LEADS EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS, EXTENSION, AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23094096 ↗InjurySep 19, 2025High impedance; High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. IT WAS ALSO REPORTED THAT PATIENT HAS AN ACTIVE LIFESTYLE AND USES A RIDING LAWN MOWER. DIAGNOSTICS REVEALED THAT BOTH OF PATIENT'S LEADS EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS, EXTENSION, AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23094091 ↗InjuryAug 29, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY DUE TO LEAD MIGRATION. THE ISSUE WAS CONFIRMED VIA X-RAYS. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE LEADS WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-SURGERY.
Patient problems: Inadequate Pain Relief
MAUDE report 22920859 ↗InjuryAug 29, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY DUE TO LEAD MIGRATION. THE ISSUE WAS CONFIRMED VIA X-RAYS. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE LEADS WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-SURGERY.
Patient problems: Inadequate Pain Relief
MAUDE report 22920858 ↗InjuryJul 2, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ALL OF THE LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM APART FROM A FRACTURED LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22379617 ↗InjuryJul 2, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ALL OF THE LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM APART FROM A FRACTURED LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22379615 ↗InjuryMay 13, 2025High impedance; High impedance
IT WAS REPORTED THAT DURING AN IPG REPLACEMENT PROCEDURE ON (B)(6) 2024, THE PATIENT HAD INTRA-OP HIGH IMPEDANCES ON BOTH LEADS. A FEW DAYS AFTER SURGERY, THE PATIENT ALSO EXPERIENCED AN UNSPECIFIED TRAUMATIC INCIDENT. EFFECTIVE THERAPY HAS NOT BEEN ESTABLISHED. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22012625 ↗InjuryMay 13, 2025High impedance; High impedance
IT WAS REPORTED THAT DURING AN IPG REPLACEMENT PROCEDURE ON (B)(6) 2024, THE PATIENT HAD INTRA-OP HIGH IMPEDANCES ON BOTH LEADS. A FEW DAYS AFTER SURGERY, THE PATIENT ALSO EXPERIENCED AN UNSPECIFIED TRAUMATIC INCIDENT. EFFECTIVE THERAPY HAS NOT BEEN ESTABLISHED. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22012613 ↗InjuryMar 31, 2025Low impedance; Low impedance
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHERE THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 21734993 ↗InjuryMar 31, 2025Low impedance; Low impedance
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHERE THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 21734991 ↗InjuryMar 27, 2025High impedance; Migration; High impedance; Migration
ADDITIONAL INFORMATION WAS OBTAINED, REVEALING THAT THE LEADS WERE REPLACED VIA SURGICAL INTERVENTION ON (B)(6) 2025. PRIOR TO SURGERY, X-RAY IMAGING CONFIRMED THAT BOTH LEADS HAD MIGRATED. THERAPY WAS RESTORED POST OP.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21708832 ↗InjuryMar 27, 2025Therapeutic or Diagnostic Output Failure; Migration; Therapeutic or Diagnostic Output Failure; Migration
ADDITIONAL INFORMATION WAS OBTAINED, REVEALING THAT THE LEADS WERE REPLACED VIA SURGICAL INTERVENTION ON (B)(6) 2025. PRIOR TO SURGERY, X-RAY IMAGING CONFIRMED THAT BOTH LEADS HAD MIGRATED. THERAPY WAS RESTORED POST OP.
Patient problems: Inadequate Pain Relief
MAUDE report 21708817 ↗InjuryOct 2, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT'S OCCIPITAL LEADS MIGRATED. AS A RESULT, THE LEADS WERE EXPLANTED AND LATER REPLACED VIA SURGICAL INTERVENTION ON (B)(6) 2024.
Patient problems: Inadequate Pain Relief
MAUDE report 20352150 ↗InjurySep 4, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT'S LEAD HAD MIGRATED AND AS A RESULT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE WHERE THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.
Patient problems: Inadequate Pain Relief
MAUDE report 20136736 ↗
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-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-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-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-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-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-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-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
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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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