Octrode™ 3183 (UDI 05415067017420)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 05415067017420), received between Jul 25, 2018 and May 11, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (10 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. NOTE : IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25134903 ↗
• InjuryFeb 2, 2026High impedance

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 24240757 ↗
• InjuryJan 6, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT THERAPY WAS OFF DUE TO HIGH IMPEDANCE ON THE LEAD. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE. REPORTEDLY, A NEW LEAD UNABLE TO BE IMPLANTED DUE TO FIBROSIS. DATE OF IMPLANT IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 21086480 ↗
• InjuryJan 15, 2024High impedance; High impedance

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES. ATTEMPTS TO REPROGRAM WERE UNSUCCESSFUL, AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18511054 ↗
• InjuryJan 2, 2024Fracture; Fracture

  RELATED MANUFACTURER REPORT NUMBER 1627487-2024-00018. IT WAS REPORTED THAT THE PATIENT'S LEADS WERE FRACTURED. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18428688 ↗
• InjuryJan 2, 2024Fracture; Fracture

  RELATED MANUFACTURER REPORT NUMBER 1627487-2024-00017. IT WAS REPORTED THAT THE PATIENT'S LEADS WERE FRACTURED. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18428680 ↗
• InjuryDec 28, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY AND PAIN AT IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHERE THE IPG AND LEAD WAS REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED INEFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18415341 ↗
• InjuryAug 31, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  THE THERAPY WAS REPORTEDLY NOT WORKING FOR THE PATIENT. SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE IN WHICH THE PATIENT'S SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17661486 ↗
• InjuryNov 21, 2022Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06356. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO MIGRATION OF BOTH LEADS. 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: Inadequate Pain Relief

  MAUDE report 15834803 ↗
• InjuryNov 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT PATIENT'S LEAD HAD HIGH IMPEDANCE DUE TO A FRACTURE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022, WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15759438 ↗
• InjuryAug 17, 2022High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-04111. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-04110. IT WAS REPORTED THE PATIENTS LEAD DISPLAYED HIGH IMPEDANCE AND THE IPG WAS INOPERABLE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15243461 ↗
• InjuryJul 28, 2022Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-04149. IT WAS REPORTED THE PATIENT¿S LEADS MIGRATED. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15121758 ↗
• InjuryJul 28, 2022Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-04150. IT WAS REPORTED THE PATIENT¿S LEADS MIGRATED. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15121751 ↗
• InjuryDec 1, 2021High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-03148, 1627487-2021-18484. IT WAS REPORTED THE PATIENT WAS EXPERIENCING SHOCKING PAINS AT THE SCS SYSTEM IMPLANTABLE PULSE GENERATOR'S IMPLANT SITE. REPORTEDLY, THE PATIENT FELL INTO A CHAIR AND LANDED ON THE GENERATOR SITE. SINCE THE PATIENT EXPERIENCES AN INTERMITTENT SHOCKING WHILE WALKING, BENDING OVER AND DOING OTHER PHYSICAL ACTIVITIES. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO RESOLVE THE ISSUE. DURING THE PROCEDURE THE PATIENT ASPIRATED AND THE PROCEDURE WAS COMPLETED AS THERE WAS NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12909045 ↗
• InjuryDec 1, 2021High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-03148, 1627487-2021-18485. IT WAS REPORTED THE PATIENT WAS EXPERIENCING SHOCKING PAINS AT THE SCS SYSTEM IMPLANTABLE PULSE GENERATOR'S IMPLANT SITE. REPORTEDLY, THE PATIENT FELL INTO A CHAIR AND LANDED ON THE GENERATOR SITE. SINCE THE PATIENT EXPERIENCES AN INTERMITTENT SHOCKING WHILE WALKING, BENDING OVER AND DOING OTHER PHYSICAL ACTIVITIES. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO RESOLVE THE ISSUE. DURING THE PROCEDURE THE PATIENT ASPIRATED AND THE PROCEDURE WAS COMPLETED AS THERE WAS NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12909038 ↗
• InjuryFeb 8, 2021High impedance; High impedance

  RELATED MANUFACTURER REPORT: 1627487-2021-00995. IT WAS REPORTED THAT HIGH IMPEDANCE ISSUE WAS OBSERVED ON THE LEAD. LEAD AND EXTENSION WERE EXPLANTED AND A NEW LEAD WAS IMPLANTED AS A RESULT. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. EFFECTIVE THERAPY WAS RESTORED POST PROCEDURE. PATIENT WAS STABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11298563 ↗
• InjuryFeb 4, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-00904. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-00905. IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, TO ADDRESS THE ISSUE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEADS AND IPG WERE EXPLANTED AND REPLACED WITH A NEW PENTA LEAD AND IPG. REPORTEDLY EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11281966 ↗
• InjuryOct 29, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-33068, 1627487-2020-33069, 1627487-2020-33070, 1627487-2020-33071, 3006705815-2020-32352, 3006705815-2020-32351, 1627487-2020-33110. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH OF THE PATIENT'S SYSTEMS WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10757406 ↗
• InjuryOct 29, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-33068, 1627487-2020-33069, 1627487-2020-33070, 1627487-2020-33071, 3006705815-2020-32352, 3006705815-2020-32351, 1627487-2020-33111. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH OF THE PATIENT'S SYSTEMS WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10757358 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURNING SENSATION AT THE ELECTRODE SITE WITH STIMULATION ON AND WHILE STANDING. THE REPORTED SYMPTOM DISAPPEARS ONCE THE STIMULATION IS TURNED OFF. IMPEDANCE CHECK AND X-RAYS SHOWED NO ANOMALY. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Burning Sensation

  MAUDE report 10603449 ↗
• InjurySep 28, 2020Fracture; High impedance; Material Twisted/Bent; Fracture; High impedance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT LOST THERAPY AND THE IPG TURNED OFF. DIAGNOSTICS SHOWED HIGH IMPEDANCE AND X-RAY CONFIRMED A KINK ON THE LEAD. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. IN TURN, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2020 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD RESOLVING THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OPERATIVELY. NOTE: THE REPORTED LEAD WAS IMPLANTED IN (B)(6) 2015. EXACT IMPLANT DATE IS UNKNOWN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10597662 ↗
• InjurySep 24, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2020-31604, 3006705815-2020-31605. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10579639 ↗
• InjuryAug 18, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-24113. IT WAS REPORTED THE PATIENT EXPERIENCED POSITIONAL STIMULATION. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10418564 ↗
• InjuryAug 18, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-24112. IT WAS REPORTED THE PATIENT EXPERIENCED POSITIONAL STIMULATION. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10418562 ↗
• InjuryJul 30, 2020Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2020-30457. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IMAGING REVEALED THAT THE LEADS HAD MIGRATED. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ENTIRE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10344343 ↗

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-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-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-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