Octrode™ 3189 (UDI 05415067017314)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067017314), received between Nov 6, 2018 and May 3, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “High impedance” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT HAS INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25064275 ↗
• InjuryDec 3, 2025High impedance; Therapeutic or Diagnostic Output Failure; High impedance; Therapeutic or Diagnostic Output Failure

  ADDITIONAL INFORMATION REVEALED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23706918 ↗
• InjuryOct 16, 2023High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-04927. IT WAS REPORTED THAT THE PATIENT'S LEADS HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEADS WERE EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17944154 ↗
• InjuryOct 16, 2023High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT'S LEADS HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEADS WERE EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17943998 ↗
• InjuryJan 10, 2023High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00138. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THEIR OCCIPITAL SYSTEM DUE TO HIGH IMPEDANCES ON THEIR LEADS. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2022 DURING WHICH THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16132793 ↗
• InjuryJan 10, 2023High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00139. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THEIR OCCIPITAL SYSTEM DUE TO HIGH IMPEDANCES ON THEIR LEADS. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2022 DURING WHICH THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16132785 ↗
• InjuryDec 28, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06790. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY CONFIRMED ONE OF THE LEADS WERE FRACTURED. THERAPY COULD NOT BE DELIVERED WITH THE SECOND LEAD. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16064070 ↗
• InjuryDec 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEAD WAS FRACTURED. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15987136 ↗
• InjuryDec 8, 2022Fracture; Fracture

  IT WAS REPORTED THE PATIENT EXPERIENCED A LEAD FRACTURE. IN TURN, THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15939543 ↗
• InjuryDec 2, 2022Fracture; Fracture

  IT WAS REPORTED THE PATIENTS LEAD FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15911393 ↗
• InjuryDec 2, 2022Fracture; Fracture

  IT WAS REPORTED THE PATIENTS LEAD FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15910760 ↗
• InjuryNov 4, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD CAUSED THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15739564 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2. REFERENCE MFR. REPORT# 1627487-2018-08669. IT WAS REPORTED ((B)(6)) THE PATIENT¿S LEADS WERE ERODED THROUGH THE SKIN. AS A RESULT, THE LEADS WERE CUT AND RETRACTED BACK (DATE OF SURGERY UNKNOWN). ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE SCS SYSTEM WAS EXPLANTED DUE TO THE ISSUE.

  Patient problems: Erosion

  MAUDE report 8042738 ↗

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-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-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-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-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