Octrode™ 3186 (UDI 05414734406130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 536 adverse event reports that list this exact device (DI 05414734406130), received between Jun 27, 2018 and Sep 4, 2026 — classified as 534 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (149 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 536 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50623100 ↗
• InjuryJul 13, 2026Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT'S LEADS WERE CUT DURING BACK SURGERY. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026, AND THE CUT LEADS WERE EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807965 ↗
• InjuryMar 4, 2026High impedance

  IT WAS REPORTED THAT FOLLOWING A COUPLE OF FALLS PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEADS HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24509412 ↗
• InjuryFeb 25, 2026Migration

  IT WAS REPORTED THAT A LEAD HAD MIGRATED RESULTING IN STIMULATION IN THE PATIENT'S RIBS. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24443303 ↗
• InjuryFeb 3, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. BILATERAL MIGRATION WAS CONFIRMED. AS RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24252021 ↗
• InjuryJan 29, 2026Impedance Problem

  IT WAS REPORTED ONE OF THE PATIENT'S LEADS HAS MULTIPLE IMPEDANCES. DIAGNOSTICS SHOW BOTH LOW AND HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214975 ↗
• InjuryJan 14, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT HAS HIGH IMPEDANCES. X-RAY IMAGING CONFIRMED LEAD FRACTURE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS FRACTURED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24068783 ↗
• InjuryJan 2, 2026Migration

  ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23952705 ↗
• InjuryDec 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906903 ↗
• InjuryDec 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906896 ↗
• InjuryDec 24, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED PATIENT'S LEADS HAD HIGH IMPEDANCES PREVENTING PATIENT MRI CAPABILITIES. INVESTIGATION WAS UNABLE TO IDENTIFY WHICH LEAD ATTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23891285 ↗
• InjuryOct 22, 2025Migration; Migration

  ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED DUE TO MIGRATION. BILATERAL MIGRATION WAS CONFIRMED WITH IMAGING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23360915 ↗
• InjuryOct 21, 2025High impedance; High impedance

  IT WAS REPORTED PATIENT HAD HIGH IMPEDANCES ON ONE LEAD AND LOST EFFECTIVE THERAPY AS A RESULT. INVESTIGATION WAS UNABLE TO IDENTIFY WHICH LEAD ATTRIBUTED TO THE ISSUE. TO ADDRESS THE ISSUE, PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23350454 ↗
• InjurySep 10, 2025High impedance; High impedance

  IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23014480 ↗
• InjurySep 9, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE SYSTEM HAD INVALID IMPEDANCES. REPROGRAMMING WAS UNABLE TO RESTORE EFFECTIVE THERAPY. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005608 ↗
• InjurySep 5, 2025Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE SYSTEM HAS IMPEDANCES. REPROGRAMMING WAS UNABLE TO RESTORE EFFECTIVE THERAPY. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED / CONTRIBUTED TO THE EVENT.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976995 ↗
• InjuryAug 26, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IMAGING CONFIRMED BILATERAL LEAD MIGRATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BILATERAL LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22896067 ↗
• InjuryAug 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER MRI MODE DUE TO HIGH IMPEDANCES. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD ATTRIBUTED TO THIS ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854573 ↗
• InjuryAug 15, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IMAGING REVEALED BILATERAL LEAD MIGRATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22819671 ↗
• InjuryAug 15, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IMAGING REVEALED BILATERAL LEAD MIGRATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22819670 ↗
• InjuryJul 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PATIENT'S EXPLANT PROCEDURE ON (B)(6) 2025 [RELATED MANUFACTURER REPORT NUMBER: 3006705815-2025-05370] ONE OF THE PATIENTS LEADS WAS BROKEN AND COULD NOT BE EXPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO REMOVE REMAINING PORTION OF LEAD. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22671789 ↗
• InjuryJul 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. ADDITIONALLY, PATIENT REPORTED INEFFECTIVE STIMULATION, AND THE SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON BILATERAL LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG AND BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22591787 ↗
• InjuryJul 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. ADDITIONALLY, PATIENT REPORTED INEFFECTIVE STIMULATION, AND THE SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON BILATERAL LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG AND BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22591712 ↗
• InjuryJul 2, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE. IT IS UNKNOWN WHICH LEAD ATTRIBUTED TO THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22387561 ↗
• InjuryJun 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, X-RAY IMAGING REVEALED PATIENTS' LEADS WERE FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22290223 ↗

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-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-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-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-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-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