Octrode® 3183Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05414734401692), received between Jul 25, 2018 and Apr 10, 2026 — classified as 52 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (16 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Therapeutic or Diagnostic Output Failure

  ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON 30MAR2026 WHEREIN BOTH SYSTEMS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24845215 ↗
• InjuryMay 12, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22003669 ↗
• InjuryFeb 11, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD ATTRIBUTED TO THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21352159 ↗
• InjurySep 4, 2024High impedance; High impedance

  IT WAS REPORTED THAT DURING AN IPG REPLACEMENT (RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2024-05356) SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES BUT NOT OUT OF RANGE ON THE RIGHT LEAD. PATIENT ALSO STATED COVERAGE WAS TOO HIGH IN THE OCCIPITAL AREA WHERE THE HEADACHES ARE LOCATED. SURGICAL INTERVENTION TOOK PLACE WHERE THE LEADS WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED.

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

  MAUDE report 20133079 ↗
• InjuryJul 2, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE FALLS, AND AS A RESULT THE PATIENT'S SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES. IT WAS ALSO REPORTED THAT THE PATIENT'S IPG WAS END OF LIFE, AND AS A RESULT THE PATIENT HAD INEFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE WHERE THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19657077 ↗
• InjuryApr 26, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCE AND WAS EXPERIENCING A RECHARGE BURDEN WITH THEIR IPG. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY. THE PATIENT MAY UNDERGO FURTHER SURGICAL INTERVENTION AT A LATER DATE TO REPLACE THEIR IPG ONCE NEWER TECHNOLOGY IS AVAILABLE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19195660 ↗
• InjurySep 11, 2023Use of Device Problem; Use of Device Problem

  RELATED MANUFACTURER REPORT NUMBER 1627487-2023-04342. IT WAS REPORTED THAT DURING AN ELECTIVE IPG REPLACEMENT, THE PHYSICIAN PULLED OUT BOTH LEADS ALONG WITH THE IPG. IN TURN, THE LEADS WERE EXPLANTED. NOTHING WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720163 ↗
• InjurySep 11, 2023Use of Device Problem; Use of Device Problem

  RELATED MANUFACTURER REPORT NUMBER 1627487-2023-04341. IT WAS REPORTED THAT DURING AN ELECTIVE IPG REPLACEMENT, THE PHYSICIAN PULLED OUT BOTH LEADS ALONG WITH THE IPG. IN TURN, THE LEADS WERE EXPLANTED. NOTHING WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720154 ↗
• InjuryJul 7, 2023Low impedance; Low impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03181. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03182. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03183. IT WAS REPORTED THAT THE PATIENT NEVER EXPERIENCED EFFECTIVE THERAPY FROM THEIR OCCIPITAL SCS SYSTEM FOR THEIR MIGRAINES. THE IPG FOR THEIR OCCIPITAL SYSTEM IN INOPERABLE. ADDITIONALLY, THE PATIENT EXPERIENCED INEFFECTIVE THERAPY FROM THEIR LUMBAR SCS SYSTEM DUE TO HIGH AND LOW IMPEDANCES. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE OCCIPITAL LEADS ATTRIBUTED TO THE INEFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17280948 ↗
• InjuryJul 7, 2023High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2023 WHEREIN THE OCCIPITAL SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE WITH THIS SYSTEM. ADDITIONALLY, THE LUMBAR SYSTEM WAS ALSO EXPLANTED AND REPLACED WITH A NEW SYSTEM TO ADDRESS THE ISSUE WITH THE LUMBAR SYSTEM. REPORTEDLY, THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17280924 ↗
• InjuryOct 21, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-05773 IT WAS REPORTED THAT THE PATIENT STOPPED CHARGING THE IPG YEARS AGO DUE TO INEFFECTIVE THERAPY, RENDERING THE IPG INOPERABLE. AS SUCH, THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE 2 LEADS WAS INEFFECTIVE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15651478 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN EXPLANTED THE LEAD FOR SUSPICION OF AN INFECTION. PATIENT WILL BE EVALUATED AND PUT ON A COURSE OF ANTIBIOTICS TO ADDRESS THE ISSUE. EXTENSION REMAINS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 15459824 ↗
• InjuryJul 1, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDESIRED NERVE STIMULATION IN THEIR RIBS. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 14893269 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED PAIN AT THE LEAD SITE. IN TURN, THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 14194313 ↗
• InjuryJan 27, 2022High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00465. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE ISSUE ON BOTH LEADS. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXISTING LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13365863 ↗
• InjuryJan 27, 2022High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00466. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE ISSUE ON BOTH LEADS. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXISTING LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13365862 ↗
• InjuryDec 20, 2021Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-06360, 1627487-2021-19102. IT WAS REPORTED THE PATIENT¿S IPG WAS INOPERABLE. DURING THE PROCEDURE IT WAS NOTICED ONE OF THE LEADS HAD MIGRATED. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS REPLACED, AND THE LEAD WAS EXPLANTED TO RESOLVE THE ISSUE. IT IS UNKNOWN WHICH LEAD MIGRATED, AS SUCH BOTH LEADS ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13043449 ↗
• InjuryDec 20, 2021Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-06360, 1627487-2021-19103. IT WAS REPORTED THE PATIENT¿S IPG WAS INOPERABLE. DURING THE PROCEDURE IT WAS NOTICED ONE OF THE LEADS HAD MIGRATED. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS REPLACED, AND THE LEAD WAS EXPLANTED TO RESOLVE THE ISSUE. IT IS UNKNOWN WHICH LEAD MIGRATED, AS SUCH BOTH LEADS ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13043445 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2021-18989, 1627487-2021-18990, 1627487-2021-18991. IT WAS REPORTED THAT PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 IN WHICH THE LEADS AND EXTENSIONS WERE EXPLANTED AND ONLY LEADS WERE REPLACED, RESOLVING THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 13013036 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2021-18988, 1627487-2021-18990, 1627487-2021-18991. IT WAS REPORTED THAT PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 IN WHICH THE LEADS AND EXTENSIONS WERE EXPLANTED AND ONLY LEADS WERE REPLACED, RESOLVING THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 13013015 ↗
• InjuryNov 7, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-05492. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO THE LEADS ORIGINALLY BEING PLACED TOO LOW. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 WHEREIN THE LEADS WERE EXPLANTED, REPLACED, AND REPOSITIONED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12763915 ↗
• InjuryJul 28, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15927. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM, AND STOPPED USING THEIR SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12238238 ↗
• InjuryMay 13, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INCREASE THE STIMULATION AMPLITUDE. THE STIMULATION STRENGTH DECREASED ON ITS OWN. PATIENT WAS UNABLE TO BE PROGRAMMED DUE TO IMPEDANCES SHOWING HIGH. AS A RESULT, TO ADDRESS THE ISSUE PATIENT MAY UNDERGO SURGICAL INTERVENTION AT A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11822069 ↗
• InjuryApr 7, 2021High impedance; High impedance

  IT WAS REPORTED THE PATIENT'S SCS SYSTEM LEAD WAS EXHIBITING HIGH IMPEDANCE. SURGICAL INTERVENTION WAS TAKEN AND THE PHYSICIAN DECIDED TO REMOVE THE PATIENT'S SCS SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11630400 ↗
• InjuryFeb 14, 2021Low impedance; Low impedance

  DEVICE 2 OF 2 REFERENCE MFR. REPORT#: (B)(4). ADDITIONAL INFORMATION OBTAINED REVEALED SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2021. DURING THE PROCEDURE THE PATIENT'S LEADS WERE REMOVED, CLEANED, AND REINSERTED INTO THEIR IPG WITH IMPEDANCES BEING WITHIN NORMAL RANGE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11326107 ↗

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-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-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-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-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-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-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