Quattrode™ 3146 (UDI 05414734406048)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05414734406048), received between Jul 12, 2018 and Jun 2, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “High impedance” (4 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF ONE LEAD. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD MIGRATED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25365354 ↗
• InjuryFeb 2, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN FULL SYSTEM WAS EXPLANTED. IT IS UNKNOWN WHICH LEAD IS A FAULT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18631480 ↗
• InjuryJan 3, 2024Migration; Migration

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2024-00026. 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 18440716 ↗
• InjuryApr 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-01813, 1627487-2023-01814. IT WAS REPORTED THAT THE PATIENT'S OCTRODE LEADS HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEADS WERE EXPLANTED AND REPLACED. DURING THE PROCEDURE A QUATTRODE LEAD WAS NOT ATTACHED TO ANY GENERATOR AND THE LEAD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16764004 ↗
• InjuryJan 20, 2022Impedance Problem; Impedance Problem

  RELATED MANUFACTURER REPORT NUMBER: 3006705815-2022-00305 AND 1627487-2022-00357. IT WAS REPORTED THAT ONE OF THE PATIENT¿S LEADS HAS IMPEDANCE ISSUE CAUSING INEFFECTIVE STIMULATION. AS RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION ON A LATER DATE. IT IS UNKNOWN WHICH LEADS HAS IMPEDANCE ISSUE SO BOTH ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13307969 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2021-19453. IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPOSITION THE LEADS. DURING THE PROCEDURE THE LEADS MIGRATED RESULTING IN THE LEADS BEING EXPLANTED AND REPLACED RESOLVING THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 13119618 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2021-19452. IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPOSITION THE LEADS. DURING THE PROCEDURE THE LEADS MIGRATED RESULTING IN THE LEADS BEING EXPLANTED AND REPLACED RESOLVING THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 13119617 ↗
• InjuryDec 17, 2021High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2021-18968, 1627487-2021-18969, 1627487-2021-18970, 3006705815-2021-06240. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE ON MULTIPLE LEADS. AS A RESULT, A SURGICAL INTERVENTION OCCURRED WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13030755 ↗
• InjuryDec 15, 2021High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2021-18967, 1627487-2021-18968, 1627487-2021-18969, 3006705815-2021-06240. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE ON MULTIPLE LEADS. AS A RESULT, A SURGICAL INTERVENTION OCCURRED WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13011261 ↗
• InjuryDec 15, 2021High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2021-18967, 1627487-2021-18968, 1627487-2021-18970, 3006705815-2021-06240. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE ON MULTIPLE LEADS. AS A RESULT, A SURGICAL INTERVENTION OCCURRED WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13011237 ↗
• InjuryDec 15, 2021High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2021-18967, 1627487-2021-18969, 1627487-2021-18970, 3006705815-2021-06240. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE ON MULTIPLE LEADS. AS A RESULT, A SURGICAL INTERVENTION OCCURRED WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13011232 ↗
• InjuryNov 12, 2021Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-18112, 1627487-2021-18113. IT WAS REPORTED THE PATIENT STOPPED CHARGING THE DEVICE AS RECOMMENDED AFTER EXPERIENCING AUTO-REDUCING AT AN UNKNOWN DATE. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12806822 ↗
• InjuryNov 12, 2021Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-18112, 1627487-2021-18114. IT WAS REPORTED THE PATIENT STOPPED CHARGING THE DEVICE AS RECOMMENDED AFTER EXPERIENCING AUTO-REDUCING AT AN UNKNOWN DATE. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12806664 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-13274. IT WAS REPORTED THE PATIENT EXPERIENCED DISCOMFORT DUE TO SCAR TISSUE. IN TURN, THE LEAD WAS REPOSITIONED ON (B)(6) 2021 TO ADDRESS THE ISSUE. NOTE: ALL OF THE PATIENT'S LEADS ARE BEING REPORTED BECAUSE IT IS UNKNOWN WHICH LEAD IS LIABLE.

  Patient problems: Discomfort

  MAUDE report 11688375 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 4: REFERENCE MFR. REPORT# 1627487-2018-06409; REFERENCE MFR. REPORT# 1627487-2018-06411; REFERENCE MFR. REPORT# 1627487-2018-06412. IT WAS REPORTED THE PATIENT NEVER EXPERIENCED EFFECTIVE STIMULATION. IN TURN THE ENTIRE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7681944 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 4. REFERENCE MFR. REPORT# 1627487-2018-06410, REFERENCE MFR. REPORT# 1627487-2018-06411, REFERENCE MFR. REPORT# 1627487-2018-06412. IT WAS REPORTED THE PATIENT NEVER EXPERIENCED EFFECTIVE STIMULATION. IN TURN THE ENTIRE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7681931 ↗

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, Classified
  Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
• Z-2506-2023 · Jul 18, 2023 · Open, Classified
  Proclaim" 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-2505-2023 · Jul 18, 2023 · Open, Classified
  Proclaim 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-2508-2023 · Jul 18, 2023 · Open, Classified
  Proclaim 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, Classified
  Proclaim 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, Classified
  Infinity 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-2507-2023 · Jul 18, 2023 · Open, Classified
  Proclaim 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-2510-2023 · Jul 18, 2023 · Open, Classified
  Infinity 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-2692-2017 · Jun 2, 2017 · Terminated
  Proclaim 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 · Terminated
  Proclaim 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 · Terminated
  Eon 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 · Terminated
  The 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 · Terminated
  Eon - 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 · Terminated
  Software 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