Octrode™ 3183 (UDI 05414734406123)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05414734406123), received between Sep 11, 2018 and Jan 21, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Migration” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2025High impedance; High impedance

  IT WAS REPORTED PATIENT HAD SEVERAL HIGH IMPEDANCES ON THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 21198874 ↗
• InjuryJun 3, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENTS LEADS HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455640 ↗
• InjuryJun 3, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENTS LEADS HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455639 ↗
• InjuryMar 7, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A DRG TRIAL ON 16FEB2024 DUE TO INEFFECTIVE STIMULATION THEY WERE EXPERIENCING WITH BOTH SCS SYSTEMS. THE INVESTIGATION DID NOT DETERMINE WHICH 3183 LEAD ATTRIBUTED TO THE ISSUE. FURTHER INTERVENTION MAY BE PENDING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18861175 ↗
• InjuryJan 23, 2024High impedance; Migration; High impedance; Migration

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2024-00381. IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON BOTH IMPLANTED LEADS AS WELL AS BOTH IMPLANTED LEADS HAD MIGRATED. X-RAYS TAKEN INTRAOPERATIVELY CONFIRMED BOTH LEADS HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN BOTH PATIENT'S LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18561352 ↗
• InjuryJan 23, 2024High impedance; Migration; High impedance; Migration

  RELATED MANUFACTURER REPORT NUMBER: (B)(4) IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON BOTH IMPLANTED LEADS AS WELL AS BOTH IMPLANTED LEADS HAD MIGRATED. X-RAYS TAKEN INTRAOPERATIVELY CONFIRMED BOTH LEADS HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN BOTH PATIENT'S LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18561348 ↗
• InjuryJan 26, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT SURGICAL INTERVENTION WAS UNDERTAKEN IN WHICH THE PATIENT'S LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16246006 ↗
• InjuryDec 16, 2020Migration; Migration

  REFERENCE MANUFACTURER NUMBER: 1627487-2020-48884. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM SEVERAL FALLS THAT COINCIDED WITH A LOSS OF THERAPY. X-RAYS WERE TAKEN WHICH CONFIRMED SLIGHT LEAD MIGRATION OF THE LEFT SCS PERCUTANEOUS LEAD. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN BOTH SCS LEADS WERE EXPLANTED AND REPLACED WITH A PADDLE LEAD TO ADDRESS THE ISSUE. SINCE IT IS NOT KNOWN WHICH DEVICE CONTRIBUTED TO THE ISSUE, ALL POSSIBLE DEVICES ARE BEING REPORTED ON.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11019998 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 3: REFERENCE MFR REPORT # 1627487-2019-03297, REFERENCE MFR REPORT # 3006705815-2019-00929. IT IS REPORTED THAT PATIENT WAS NOT RECEIVING ADEQUATE THERAPY FROM THE SCS SYSTEM. IN TURN, THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8412820 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 5 OF 6. REFERENCE MFR REPORT # 1627487-2019-02487, REFERENCE MFR REPORT # 1627487-2019-02488, REFERENCE MFR REPORT # 1627487-2019-02489, REFERENCE MFR REPORT # 1627487-2019-02490, REFERENCE MFR REPORT # 1627487-2019-02492. IT WAS REPORTED THAT PATIENT HAD BOTH OF THEIR PNS SYSTEMS EXPLANTED. PER PATIENT, THE SYSTEMS WERE NO LONGER WORKING AND WANTED TO HAVE THEM EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8358359 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER FOLLOW-UP INDICATES THE PATIENT HAD SURGICAL INTERVENTION ON (B)(6) 2018, DURING WHICH THE PATIENT'S LEAD WAS REPOSITIONED TO RESOLVE THIS ISSUE.

  Patient problems: Pain; Skin Erosion

  MAUDE report 8039929 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2: REFERENCE MFR. REPORT#1627487-2018-08220. IT WAS REPORTED THAT THE PATIENT NEVER EXPERIENCED EFFECTIVE STIMULATION FROM THE SCS SYSTEM. MULTIPLE REPROGRAMMING'S WERE ATTEMPTED TO NO AVAIL. AS SUCH, THE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7867267 ↗

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-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-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-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-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