Quattrode™ 3149 (UDI 05414734401593)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 05414734401593), received between Oct 23, 2018 and Aug 3, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (17 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following weight loss, the patient experienced skin erosion at the lead and extension sites. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Erosion

  MAUDE report 50119092 ↗
• InjuryOct 4, 2024High impedance; High impedance

  ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024 WHEREIN ALL THE THREE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 20375227 ↗
• InjuryMar 4, 2024Impedance Problem; Impedance Problem

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT'S LEADS HAD INVALID IMPEDANCES. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833349 ↗
• InjuryMar 4, 2024Impedance Problem; Impedance Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-07335, 1627487-2024-07336,1627487-2024-07338. IT WAS REPORTED THAT THE PATIENT'S LEADS HAD INVALID IMPEDANCES. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833333 ↗
• InjuryAug 3, 2023High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03649. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AND BOTH OF THE PATIENT'S LEADS HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN IN THE FUTURE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17455278 ↗
• InjuryAug 3, 2023High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03650. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AND BOTH OF THE PATIENT'S LEADS HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN IN THE FUTURE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17455276 ↗
• InjuryOct 16, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2022-05484; 1627487-2022-05487. IT WAS REPORTED THE PATIENT'S IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG WAS DEEMED INOPERABLE. THE PATIENT ALSO EXPERIENCED INEFFECTIVE THERAPY IN THE SUPRAORBITAL AND OCCIPITAL REGIONS BILATERALLY. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE IPG AND LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH OF THE LEADS ARE RELATED TO INEFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15613131 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER NUMBER:1627487-2022-02645, 1627487-2022-02646, 1627487-2022-02649. IT WAS REPORTED THE PATIENT ENTIRE SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE STIMULATION. DATE OF EXPLANT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366671 ↗
• InjuryAug 26, 2021High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THE LEAD WAS REPLACED TO ADDRESS THE ISSUE. PATIENT HAD EFFECTIVE THERAPY POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12374840 ↗
• InjuryAug 26, 2021High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THE LEAD WAS REPLACED TO ADDRESS THE ISSUE. PATIENT HAD EFFECTIVE THERAPY POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12374827 ↗
• InjuryApr 13, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT SURGERY OCCURRED IN WHICH THE PATIENT'S SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11662547 ↗
• InjuryApr 13, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2021-13162, 1627487-2021-13164, 1627487-2021-13165, 1627487-2021-13166, 1627487-2021-13167, 1627487-2021-13168. IT WAS REPORTED THAT EFFECTIVE THERAPY WAS NEVER ESTABLISHED FOR THE PATIENT. AS A RESULT SURGERY MAY OCCUR TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11662545 ↗
• InjuryJan 29, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-00754, 1627487-2021-00755, 1627487-2021-00757, 1627487-2021-00758, 1627487-2021-00759, 1627487-2021-00760. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11250540 ↗
• InjuryJan 29, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-00754, 1627487-2021-00756, 1627487-2021-00757, 1627487-2021-00758, 1627487-2021-00759, 1627487-2021-00760. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11250535 ↗
• InjuryNov 26, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-31740, 1627487-2020-31741, 1627487-2020-48257, 1627487-2020-48258, 1627487-2020-48262, 1627487-2020-48263, 1627487-2020-48264, 1627487-2020-48265, 1627487-2020-48266. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN BOTH PATIENT¿S SYSTEMS WERE EXPLANTED AND REPLACED WITH ONE IPG, THREE LEADS AND TWO EXTENSIONS. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10909214 ↗
• InjuryNov 26, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-31740, 1627487-2020-31741, 1627487-2020-48257, 1627487-2020-48258, 1627487-2020-48261, 1627487-2020-48263, 1627487-2020-48264, 1627487-2020-48265, 1627487-2020-48266. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN BOTH PATIENT¿S SYSTEMS WERE EXPLANTED AND REPLACED WITH ONE IPG, THREE LEADS AND TWO EXTENSIONS. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10909173 ↗
• InjuryOct 10, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-32255, 1627487-2020-32256, 1627487-2020-32258, 1627487-2020-32260, 1627487-2020-32261, 1627487-2020-32262. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10660058 ↗
• InjuryOct 10, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-32255, 1627487-2020-32256, 1627487-2020-32257, 1627487-2020-32260, 1627487-2020-32261, 1627487-2020-32262. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10660057 ↗
• InjuryOct 6, 2020High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-32027. 1627487-2020-32028. 1627487-2020-32030. 1627487-2020-32031. 1627487-2020-32033. 1627487-2020-32034. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY ON THE LEFT SIDE. DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE. REPROGRAMMING DID NOT RESOLVE THE ISSUE. SURGERY MAY OCCUR TO ADDRESS THE ISSUE. WHICH DEVICES ARE RELATED TO THE ISSUE IS UNKNOWN, SO ALL SUSPECTED DEVICES ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10632783 ↗
• InjuryOct 6, 2020High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-32028. 1627487-2020-32029. 1627487-2020-32030. 1627487-2020-32031. 1627487-2020-32033. 1627487-2020-32034. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY ON THE LEFT SIDE. DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE. REPROGRAMMING DID NOT RESOLVE THE ISSUE. SURGERY MAY OCCUR TO ADDRESS THE ISSUE. WHICH DEVICES ARE RELATED TO THE ISSUE IS UNKNOWN, SO ALL SUSPECTED DEVICES ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10632780 ↗
• InjurySep 1, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-30596, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-30597, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-30598. IT WAS REPORTED THAT PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN AT UNKNOWN DATE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 10480491 ↗
• InjurySep 1, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-30596, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-30597, RELATED MANUFACTURER REFERENCE NUMBER :1627487-2020-30599. IT WAS REPORTED THAT PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN AT UNKNOWN DATE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 10480486 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-22528; RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-22529; RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-22531. IT WAS REPORTED THE PATIENT STATED HE EXPERIENCED UNCOMFORTABLE STIMULATION. PATIENT STATED PHYSICIAN IMPLANTED LEADS IN A DIFFERENT LOCATION THAN THE LOCATION USED FOR THE TRIAL AND HE FEELS PAIN. PATIENT SAID HE HAD A LEAD REVISION PROCEDURE (DATE NOT PROVIDED), BUT THE ISSUE PERSISTED. PATIENT DESIRES TO HAVE THE SYSTEM REMOVED. AN ABBOTT REPRESENTATIVE CONTACTED THE PATIENT AND INDICATED THE SYSTEM APPEARS TO BE NONFUNCTIONAL AND THAT THE PATIENT¿S PHYSICIAN DOES NOT PLAN TO REMOVE THE SYSTEM AT THIS TIME DUE TO PATIENT¿S HEALTH CONDITIONS. PATIENT PLANS TO CONSULT WITH ANOTHER PHYSICIAN.

  Patient problems: Discomfort; Inadequate Pain Relief; Pain

  MAUDE report 10242603 ↗
• InjuryJun 11, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2020-21508, 1627487-2020-21509, 1627487-2020-21512, 1627487-2020-21513, 1627487-2020-21516, 1627487-2020-21520. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE SYSTEM WAS EXPLANTED AND REPLACED WITH A COMPETITORS DEVICE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10143756 ↗
• InjuryJun 11, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBERS: 1627487-2020-21508, 1627487-2020-21511, 1627487-2020-21512, 1627487-2020-21513, 1627487-2020-21516, 1627487-2020-21520. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE SYSTEM WAS EXPLANTED AND REPLACED WITH A COMPETITORS DEVICE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10143746 ↗

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-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-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-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-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-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-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-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-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-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