Octrode™ 3189 (UDI 05414734406147)Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 05414734406147), received between Aug 27, 2018 and May 27, 2026 — classified as 68 injuries.

The most frequently reported specific device problem is “High impedance” (23 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 68 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INEFFECTIVE THERAPY. X-RAYS REVEALED MIGRATION OF ONE LEAD. AS A RESULT, THE PATIENT HAD SURGICAL INTERVENTION ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD MIGRATED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25307171 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT WENT THROUGH IV ANTIBIOTIC TREATMENT TO ADDRESS THE ISSUE.

  Patient problems: Purulent Discharge; Skin Erosion; Unspecified Infection

  MAUDE report 24779823 ↗
• InjuryJan 7, 2026Low impedance

  IT WAS REPORTED THAT DIAGNOSTICS REVEALED LOW IMPEDANCES ON THE PATIENT'S LEAD. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995243 ↗
• InjuryJan 15, 2025High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 FOR AN ELECTIVE IPG REPLACEMENT. NOTHING WAS DONE TO THE LEAD. REPORTEDLY, MANUFACTURER WAS ABLE TO REPROGRAM AROUND THE CONTACTS WITH HIGH IMPEDANCE TO ADDRESS THE ISSUE. THE SYSTEM IS FUNCTIONING PROPERLY WITH NO ISSUE. COMPLETE COVERAGE WAS ACHIEVED.

  Patient problems: Failure of Implant; Inadequate Pain Relief; Undesired Nerve Stimulation

  MAUDE report 21163095 ↗
• InjuryDec 6, 2024Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  ADDITIONAL INFORMATION INDICATES THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, X-RAY IMAGING REVEALED PATIENTS LEAD WAS FRACTURED. PATIENT¿S IPG HAD REACHED END OF LIFE, AND IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN PATIENTS' SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT ASSOCIATED WITH THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief; Insufficient Information

  MAUDE report 20872536 ↗
• InjuryNov 15, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT HAD INEFFECTIVE STIMULATION WITH THE CERVICAL LEAD. A CERVICAL LEAD WAS ADDED ON (B)(6)2024 TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20694546 ↗
• InjuryNov 4, 2024High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE LEAD WAS ALREADY REPORTED ON (MANUFACTURER REPORT NUMBER: 1627487-2024-11690) AND THE LEAD DEVICE INFORMATION WAS CORRECTED,

  Patient problems: Inadequate Pain Relief

  MAUDE report 20601421 ↗
• InjuryOct 30, 2024High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED STATING PROGRAMMING WAS ABLE TO PROVIDE EFFECTIVE THERAPY, NO INTERVENTION TOOK PLACE. THEREFORE, DECISION IS NOT REPORTABLE

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

  MAUDE report 20565508 ↗
• InjuryOct 30, 2024High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED STATING PROGRAMMING WAS ABLE TO PROVIDE EFFECTIVE THERAPY, NO INTERVENTION TOOK PLACE. THEREFORE, DECISION IS NOT REPORTABLE

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

  MAUDE report 20565507 ↗
• InjuryJun 13, 2024Fracture; Therapeutic or Diagnostic Output Failure; Fracture; Therapeutic or Diagnostic Output Failure

  ADDITIONAL INFORMATION INDICATES, A LEAD DIAGNOSIS WAS PERFORMED AND CONFIRMED HIGH IMPEDANCES ACROSS THE LEAD. ON (B)(6) 2024 SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS CONFIRMED TO BE FRACTURED. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19532982 ↗
• InjuryMay 20, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNRELATED SURGICAL PROCEDURE. PATIENT DID SET THE IPG INTO SURGERY MODE AS RECOMMENDED. THEREAFTER, THE IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICE. RECOVERY EFFORTS WERE UNSUCCESSFUL AND THE IPG WAS DEEMED INOPERABLE. IT WAS ALSO REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED WHICH WAS CONFIRMED VIA IMAGING. THUS, THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUES. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19352065 ↗
• InjuryMay 20, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNRELATED SURGICAL PROCEDURE. PATIENT DID SET THE IPG INTO SURGERY MODE AS RECOMMENDED. THEREAFTER, THE IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICE. RECOVERY EFFORTS WERE UNSUCCESSFUL AND THE IPG WAS DEEMED INOPERABLE. IT WAS ALSO REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED WHICH WAS CONFIRMED VIA IMAGING. THUS, THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUES. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19351895 ↗
• InjuryMay 1, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY AND WAS UNABLE TO SET THEIR IPG TO MRI MODE DUE TO HIGH IMPEDANCES. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19227095 ↗
• InjuryMar 20, 2024High impedance; Migration; High impedance; Migration

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIMULATION, PATIENT'S LEAD HAS HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD HAS HIGH IMPEDANCES.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 18944468 ↗
• InjuryMar 8, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION IN THEIR OCCIPITAL AREA. SURGICAL INTERVENTION WAS UNDERTAKEN ON 06 MARCH 2024 WHEREIN THE OCCIPITAL LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18871660 ↗
• InjuryFeb 26, 2024High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-07179 RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-07180 RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-07181. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY FOLLOWING A FALL FEW MONTHS AGO. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ALL THE LEADS. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 18778985 ↗
• InjuryFeb 7, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT'S PNS SCS SYSTEM WAS NOT PROVIDING EFFECTIVE THERAPY AND AS SUCH SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024, WHERE THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18665137 ↗
• InjuryOct 23, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-06802. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED WITH A PADDLE LEAD. THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17990094 ↗
• InjuryJul 13, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE ISSUES. THE PATIENT UNDERWENT SURGICAL INTERVENTION FOR ANOTHER MEDICAL ISSUE, WHERE THE SYSTEM WAS EXPLANTED AND NOT REPLACED. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03201.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17315698 ↗
• InjuryJul 13, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE ISSUES. THE PATIENT UNDERWENT SURGICAL INTERVENTION FOR ANOTHER MEDICAL ISSUE, WHERE THE SYSTEM WAS EXPLANTED AND NOT REPLACED. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03299.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17315690 ↗
• InjuryJun 5, 2023Fracture; Fracture

  IT WAS REPORTED THE PATIENT¿S SYSTEM WAS EXPLANTED ON (B)(6) 2023 DUE TO A FRACTURED LEAD.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17066724 ↗
• InjuryMay 12, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE ISSUES. SURGICAL INTERVENTION TOOK PLACE WHERE THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16919951 ↗
• InjuryJan 24, 2023Impedance Problem; Impedance Problem

  SURGICAL INTERVENTION OCCURRED WHERE THE LEADS WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16233769 ↗
• InjuryNov 23, 2022High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: 3006705815-2022-18269 AND 1627487-2022-06409. IT WAS REPORTED THE PATIENT'S LEADS HAD HIGH AND LOW IMPEDANCES AND THEIR IPG WAS INOPERABLE. IT IS UNKNOWN WHEN THE PATIENT LAST HAD THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE PATIENT'S LEADS AND IPG WERE REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15852334 ↗
• InjuryNov 23, 2022Low impedance; Low impedance

  RELATED MANUFACTURER REPORT NUMBER: 3006705815-2022-18269 AND 1627487-2022-06410. IT WAS REPORTED THE PATIENT'S LEADS HAD HIGH AND LOW IMPEDANCES AND THEIR IPG WAS INOPERABLE. IT IS UNKNOWN WHEN THE PATIENT LAST HAD THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE PATIENT'S LEADS AND IPG WERE REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15852329 ↗

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-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-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-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-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-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-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