Octrode™ 3189 (UDI 05415067047922)Recalls & reported problems

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 05415067047922), received between Jul 24, 2023 and Sep 29, 2026 — classified as 197 injuries.

The most frequently reported specific device problem is “Migration” (104 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 197 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Migration

  It was reported that the patient experienced overstimulation. X-ray imaging revealed migration of 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: Undesired Nerve Stimulation

  MAUDE report 50937102 ↗
• InjurySep 29, 2026Migration

  It was reported that the patient experienced overstimulation. X-ray imaging revealed migration of 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: Undesired Nerve Stimulation

  MAUDE report 50937095 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50830511 ↗
• InjurySep 16, 2026Migration

  Patient problems: Inadequate Pain Relief

  MAUDE report 50794610 ↗
• InjurySep 15, 2026Migration

  It was reported that the patient experienced ineffective therapy. Imaging revealed migration of both leads. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the leads were replaced to address the issue. Therapy was restored post-operatively.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50780009 ↗
• InjurySep 15, 2026Migration

  It was reported that the patient experienced ineffective therapy. Imaging revealed migration of both leads. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the leads were replaced to address the issue. Therapy was restored post-operatively.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50779998 ↗
• InjurySep 14, 2026Migration

  It was reported that the patient experienced ineffective therapy after a recent accident. X-ray imaging revealed migration of the left lead. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50762764 ↗
• InjuryAug 24, 2026High impedance

  It was reported that the that the patient was experiencing disruption of therapy. One lead was impeded and the stimulation was shutting down even after programming on the unimpeded lead. The system would not remain in surgery mode when set for a surgical procedure. As a result, surgical intervention was undertaken on (b)(6) 2026 where the affected lead and IPG were removed and replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50420896 ↗
• InjuryAug 18, 2026Migration

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 50307000 ↗
• InjuryJul 31, 2026High impedance

  It was reported that the patient experienced ineffective therapy. Impedance check revealed high impedance on the lead. As such, surgical intervention may take place to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50105871 ↗
• InjuryJul 29, 2026Migration

  It was reported patient had a lead migration. It is unknown which lead attributed to the issue. Surgical intervention may be pending to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071630 ↗
• InjuryJul 15, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6)2026 WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25831960 ↗
• InjuryJul 9, 2026Migration

  IT WAS REPORTED THAT ONE OF THE PATIENT'S OCCIPITAL LEADS MIGRATED, CONFIRMED BY IMAGING. IT IS UNKNOWN WHICH LEAD WAS AT FAULT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25772813 ↗
• InjuryJul 9, 2026Migration

  IT WAS REPORTED THAT THE PATIENT RECENTLY LOST WEIGHT, AND EXPERIENCED PAIN AT THE THORACIC IPG SITE DUE TO IPG MIGRATION. THE PATIENT'S CERVICAL AND THORACIC LEADS WERE BOTH CONFIRMED TO HAVE MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS SUTURED DOWN IN THE POCKET, AND BOTH CERVICAL AND THORACIC LEADS WERE EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25769983 ↗
• InjuryJun 18, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. THE PHYSICIAN CONFIRMED LEAD MIGRATION FOR ONE OF THE LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE LEAD WAS REMOVED. WHILE PULLING THIS LEAD, THE GOOD LEAD ALSO CAME OUT. BOTH LEADS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25550043 ↗
• InjuryMay 27, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION AND A RASH AT THE IPG AND LEAD SITES, BELIEVED TO AN ALLERGIC REACTION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE ENTIRE SYSTEM WAS REMOVED TO ADDRESS THE ISSUE IT IS NOT KNOW WHICH LEAD CONTRIBUTED TO THE INEFFECTIVE STIMULATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25304254 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION AND A RASH AT THE IPG AND LEAD SITES, BELIEVED TO AN ALLERGIC REACTION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE ENTIRE SYSTEM WAS REMOVED TO ADDRESS THE ISSUE IT IS NOT KNOW WHICH LEAD CONTRIBUTED TO THE INEFFECTIVE STIMULATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25304225 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION AND A RASH AT THE IPG AND LEAD SITES, BELIEVED TO AN ALLERGIC REACTION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE ENTIRE SYSTEM WAS REMOVED TO ADDRESS THE ISSUE IT IS NOT KNOW WHICH LEAD CONTRIBUTED TO THE INEFFECTIVE STIMULATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25304221 ↗
• InjuryMay 26, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY ON THE LEFT SIDE FOLLOWING A MOTOR VEHICLE ACCIDENT. X-RAY IMAGING REVEALED MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH LEADS WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285266 ↗
• InjuryMay 26, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY ON THE LEFT SIDE FOLLOWING A MOTOR VEHICLE ACCIDENT. X-RAY IMAGING REVEALED MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH LEADS WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25285261 ↗
• InjuryMay 26, 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) 2026 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED THE INEFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25284669 ↗
• InjuryMay 21, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED THE MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25245910 ↗
• InjuryMay 21, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED THE MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25245895 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOLLOWING A PERMANENT IMPLANT, THE PATIENT COMPLAINED OF A SHARP, SUDDEN PAIN IN HIS LEFT ARM AND UPPER BACK. REPORTEDLY THE PATIENT EXPERIENCED A HEMATOMA AT THE CERVICAL SITE. THE PATIENT IS DOING WELL AND HAS NO NEUROLOGICAL AFTER-EFFECTS.

  Patient problems: Hematoma

  MAUDE report 25148009 ↗
• InjuryMay 6, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AND BOTH LEADS MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25096777 ↗

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-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-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-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-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-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