Octrode® 3186Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,455 adverse event reports that list this exact device (DI 05414734401708), received between Jun 14, 2018 and Sep 30, 2026 — classified as 2 deaths, 1,446 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (404 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 1,455 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Migration

  Patient problems: Inadequate Pain Relief

  MAUDE report 50949691 ↗
• InjurySep 30, 2026Migration

  Patient problems: Inadequate Pain Relief

  MAUDE report 50949687 ↗
• InjurySep 29, 2026Material Fragmentation

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50936380 ↗
• InjurySep 24, 2026Insufficient Device Problem Information

  It was reported that the patient had their lead explanted on an unknown date for an unknown reason.

  Patient problems: Insufficient Information

  MAUDE report 50883934 ↗
• InjurySep 23, 2026Therapeutic or Diagnostic Output Failure

  It was reported that one of the patient's leads exhibited high impedances. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was explanted and replaced to address the issue. Effective therapy was restored post operatively. It is unknown which lead was impeded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870989 ↗
• InjurySep 23, 2026High impedance

  It was reported that the patient¿s therapy strength was decreasing on its own. Impedance check revealed high impedances. As such, surgical intervention may take place at a later date to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50863539 ↗
• InjurySep 16, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: Inadequate Pain Relief

  MAUDE report 50794358 ↗
• InjurySep 16, 2026Malposition of Device

  It was reported that the patient's lead was not in the correct position. As a result, surgical intervention was undertaken on (b)(6) 2012 wherein the lead was replaced to address the issue. It is unknown which lead the allegation is against.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50792438 ↗
• InjurySep 16, 2026High impedance

  It was reported that the patient's leads exhibited high impedances. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790851 ↗
• InjuryAug 24, 2026High impedance

  It was reported that the patient's thoracic lead exhibited high impedances. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was explanted and replaced to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419835 ↗
• InjuryAug 23, 2026High impedance

  It was reported the patient is not receiving effective therapy due to high impedances and unable to enter MRI mode. Surgical intervention may be pending to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50394456 ↗
• InjuryAug 23, 2026High impedance

  It was reported the patient is not receiving effective therapy due to high impedances and unable to enter MRI mode. Surgical intervention may be pending to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50394455 ↗
• InjuryAug 6, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient experienced ineffective therapy with their DRG and SCS systems. The T12 DRG lead was confirmed fractured by x-ray. As a result, surgical intervention may be undertaken to address the issue. It is unknown which SCS lead is at fault.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50158750 ↗
• InjuryAug 6, 2026Migration

  It was reported that during a routine IPG replacement, x-rays confirmed the bilateral leads migrated. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50156446 ↗
• InjuryAug 6, 2026Migration

  It was reported that during a routine IPG replacement, x-rays confirmed the bilateral leads migrated. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50156441 ↗
• InjuryJul 10, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE THERAPY AND THE IPG WAS AT NORMAL END OF LIFE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE SYSTEM WAS REMOVED TO ADDRESS THE ISSUE. IT CANNOT BE DETERMINED WHICH LEAD CONTRIBUTED TO THE EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25782770 ↗
• InjuryJul 8, 2026Migration

  IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE IPG SITE AND INEFFECTIVE THERAPY. IMAGING REVEALED MIGRATION OF THE LEAD. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25748196 ↗
• InjuryJun 29, 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 THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25654063 ↗
• InjuryJun 24, 2026High impedance

  IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. THE BILATERAL LEADS HAD HIGH IMPEDANCES, AND THE PATIENT WAS UNABLE TO ENTER THEIR DEVICE INTO MRI MODE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25613086 ↗
• InjuryJun 24, 2026High impedance

  IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. THE BILATERAL LEADS HAD HIGH IMPEDANCES, AND THE PATIENT WAS UNABLE TO ENTER THEIR DEVICE INTO MRI MODE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25613077 ↗
• InjuryJun 16, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON 1(B)(6) 2026 WHERE THE SYSTEM WAS REMOVED AND REPLACED TO ADDRESS THE ISSUE. A SINGLE LEAD WAS REMOVED ALONG WITH A NORMAL EOL IPG. IT IS NOT KNOWN WHEN THE SECOND LEAD WAS REMOVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25525797 ↗
• InjuryJun 5, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. BOTH LEADS EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25410474 ↗
• InjuryJun 5, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. BOTH LEADS EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25410473 ↗
• InjuryJun 3, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS RESPONSIBLE FOR INEFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25385612 ↗
• InjuryMay 28, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS DONE ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD PRESENTED HIGH IMPEDANCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318422 ↗

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-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-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-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