Octrode™ 3189 (UDI 05414734401715)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,238 adverse event reports that list this exact device (DI 05414734401715), received between Jun 11, 2018 and Sep 29, 2026 — classified as 8 deaths, 2,225 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (629 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,238 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Low impedance

  It was reported that the patient had low impedances on both leads resulting in ineffective stimulation. Surgical intervention was undertaken on (b)(6) 2026, where the system was explanted and replaced.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50935447 ↗
• InjurySep 29, 2026Low impedance

  It was reported that the patient had low impedances on both leads resulting in ineffective stimulation. Surgical intervention was undertaken on (b)(6)2026, where the system was explanted and replaced.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50935442 ↗
• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient experienced ineffective therapy on the right side of both the thoracic and cervical systems. Additionally, the patient experienced uncomfortable stimulation with the bilateral cervical leads. Reprogramming has been unable to resolve the issue. As a result, surgical intervention was undertaken wherein the bilateral cervical leads were replaced to address the issue. Surgical intervention may be undertaken for the thoracic right lead in the future.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 50899054 ↗
• InjurySep 25, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient experienced ineffective therapy on the right side of both the thoracic and cervical systems. Additionally, the patient experienced uncomfortable stimulation with the bilateral cervical leads. Reprogramming has been unable to resolve the issue. As a result, surgical intervention was undertaken wherein the bilateral cervical leads were replaced to address the issue. Surgical intervention may be undertaken for the thoracic right lead in the future.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50899051 ↗
• InjurySep 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 wherein system was explanted to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50872160 ↗
• InjurySep 18, 2026Material Fragmentation

  It was reported that during the lead revision procedure on (b)(6) 2026 (Related Manufacturer Reference Number: 1627487-2026-10156) the lead was cut and a portion of the lead remains implanted and connected to the IPG. As such, surgical intervention may take place at a later date to explant the remaining portion of the lead.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829590 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced inflammation (swelling/redness) at the lead site. As such, surgical intervention took place (b)(6) 2026 wherein the doctor cut and removed the portion of the lead that was under the affected area. The remaining portion of the lead remains implanted and connected to the IPG(Related Manufacturer Reference Number: 1627487-2026-10157).

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 50829586 ↗
• InjurySep 18, 2026High impedance

  It was reported that the patient experienced ineffective therapy. Impedance check revealed high impedances on all contacts of the lead. As such, surgical intervention took place wherein the lead was explanted and replaced to address the issue. Reportedly, therapy was restored post op.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50828897 ↗
• InjurySep 14, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient is experiencing inadequate coverage/therapy. Additionally, patient is experiencing pain at the IPG site following weight loss. As such, surgical intervention may take place at later date to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50756969 ↗
• InjurySep 14, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient is experiencing inadequate coverage/therapy. Additionally, patient is experiencing pain at the IPG site following weight loss. As such, surgical intervention may take place at later date to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50756957 ↗
• InjurySep 3, 2026High impedance

  It was reported that the patient experienced ineffective therapy. Diagnostics revealed high impedances on both leads. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the leads were explanted and replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50587101 ↗
• InjuryAug 24, 2026Impedance Problem

  It was reported that the patient had the Abbott IPG and one lead replaced at an unknown date with a competitor product. Recently, the system, including the one remaining Abbott lead was found to have high impedances. As a result, surgical intervention was undertaken on (b)(6) 2026 where the system was removed and replaced to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421047 ↗
• InjuryAug 24, 2026Insufficient Device Problem Information

  It was reported that the patient had the Abbott IPG and one lead replaced at an unknown date with a competitor product. Recently, the system, including the one remaining Abbott lead was found to have high impedances. As a result, surgical intervention was undertaken on (b)(6) 2026 where the system was removed and replaced to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421043 ↗
• InjuryAug 23, 2026Therapeutic or Diagnostic Output Failure

  It was reported that following recent weight loss, the patient experienced pain at the IPG site. Additionally, the patient experienced ineffective therapy. As a result, surgical intervention was undertaken wherein the system was explanted to address the issue. It is unknown which lead caused ineffective therapy.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50396288 ↗
• InjuryAug 11, 2026Migration

  It was reported that the patient experienced ineffective therapy following unknown trauma. X-ray imaging revealed migration of both leads. As a result, surgical intervention may be undertaken in the future.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50211089 ↗
• InjuryJul 31, 2026Migration

  It was reported that the patient experienced ineffective therapy. X-ray imaging revealed migration of both leads. As a result, surgical intervention may be undertaken in the future.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50104965 ↗
• InjuryJul 30, 2026Migration

  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 on (b)(6) 2026 wherein the lead was repositioned to address the issue. Therapy was restored post-surgery.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50090462 ↗
• InjuryJul 28, 2026Migration

  It was reported patient's leads had migrated causing patient ineffective therapy. Surgical intervention was undertaken wherein the leads were explanted and replaced to address the issue. Therapy was restored post-op.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50055344 ↗
• InjuryJul 28, 2026Migration

  It was reported patient's leads had migrated causing patient ineffective therapy. Surgical intervention was undertaken wherein the leads were explanted and replaced to address the issue. Therapy was restored post-op.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50055309 ↗
• InjuryJul 15, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY OF THEIR CERVICAL SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS RESPONSIBLE FOR INEFFECTIVE STIM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25834169 ↗
• InjuryJun 29, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY/COVERAGE. IMPEDANCE CHECK REVEALED LOW IMPEDANCE ON ONE THE LEADS. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEAD HAD LOW IMPEDANCE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25657160 ↗
• InjuryJun 28, 2026High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. FURTHER INVESTIGATION CONFIRMED THAT ONE OF THE PATIENT¿S LEADS EXHIBITED HIGH IMPEDANCE WHILE THE OTHER SHOWED LOW IMPEDANCE, PREVENTING THE PATIENT FROM UTILIZING MRI MODE. AS A RESULT, THE PHYSICIAN REPLACED THE SYSTEM TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25648537 ↗
• InjuryJun 25, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE, INEFFECTIVE THERAPY, AND SHOCKING SENSATION. SURGICAL INTERVENTION WAS UNDERTAKEN IN OCT 2023 WHEREIN THE IPG WAS REPOSITIONED; HOWEVER, THE ISSUES PERSISTED. AS A RESULT, THE PATIENT UNDERWENT ANOTHER SURGICAL INTERVENTION WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25627390 ↗
• InjuryJun 19, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS SUCH, SUCH SURGICAL INTERVENTION TOOK PLACE IN 2024 WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EXACT DATE OF EXPLANT IS UNKNOWN. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25557172 ↗
• InjuryJun 16, 2026Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING A TRIAL WHEREIN PATIENT WAS IMPLANTED WITH 3189 LEADS, DURING THE PROCEDURE IT WAS DISCOVERED THE LEADS ONLY HAD 4 CONTACTS. DEVICE PACKAGES WERE RECEIVED CONTAINING THE INCORRECT PRODUCT. PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522651 ↗

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-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-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-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-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-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-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-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-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