Lamitrode Tripole™ 3214 (UDI 05414734406154)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734406154), received between Jun 27, 2018 and Apr 3, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “High impedance” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Impedance Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER MRI MODE. DIAGNOSTICS REVEALED HIGH AND LOW IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780501 ↗
• InjurySep 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. ATTEMPTS TO PROGRAM THE PATIENT WERE UNSUCCESSFUL. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23053783 ↗
• InjuryFeb 26, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21472995 ↗
• InjuryAug 5, 2024High impedance; High impedance

  ADDITIONAL INFORMATION INDICATES THAT PATIENT ALSO EXPERIENCED DISCOMFORT AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN LEAD WAS EXPLANTED AND REPLACED, AND THE IPG WAS EXPLANTED REPLACED AND REPOSITIONED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19914282 ↗
• InjuryJun 28, 2024High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634887 ↗
• InjuryNov 21, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WERE THE SYSTEM WAS EXPLANTED AND REPLACED WITH LEADS IN A DIFFERENT POSITION ON (B)(6) 2023. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18183455 ↗
• InjuryMay 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT¿S LEAD HAD FRACTURED RESULTING IN INFECTIVE THERAPY. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD TO ADDRESS THE ISSUE. REPORTEDLY, EFFECTIVE THERAPY WAS RESTORED POST OP.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 16858300 ↗
• InjuryApr 19, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S SCS PADDLE LEAD HAS IMPEDANCES. PATIENT MAY UNDERGO SURGICAL INTERVENTION AT A LATER DATE TO RECTIFY THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770147 ↗
• InjuryFeb 15, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD SHOCKING IN THEIR LEGS FOR A FEW MONTHS. THE PATIENT STATED THAT THE SYSTEM HAS NOT WORKED SINCE BEING IMPLANTED. REPROGRAMMING WAS TRIED BUT WAS UNSUCCESSFUL FOR THE PATIENT. SURGICAL INTERVENTION TOOK PLACE WHERE THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE SHOCKING HAS RESOLVED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 16380811 ↗
• InjuryJan 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THEIR LEAD EXPLANTED FOR AN UNKNOWN REASON ON AN UNKNOWN DATE.

  Patient problems: Insufficient Information

  MAUDE report 16163598 ↗
• InjuryApr 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE LEAD TAIL HAD FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14150457 ↗
• InjuryMar 23, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-01325. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN LEAD AND IPG WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11557692 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2019-05754. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8622730 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE THERAPY AFTER THE IMPLANT PROCEDURE ON (B)(6) 2019. POST OPERATIVE PROGRAMMING DID NOT ACHIEVE ADEQUATE THERAPY. SURGERY OCCURRED ON (B)(6) 2019 AND THE LEAD WAS REPOSITIONED. THE LEAD WAS NOT ABLE TO BE PLACED UP TO DESIRED LOCATION OF C2 DUE TO SCAR TISSUE OBSTRUCTION. IT NOW COVERS C3-4. UPON PROGRAMMING POST OPERATIVELY, MOST OF THE PAIN AREAS WERE COVERED WITH STIMULATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8604879 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS RE-POSITIONED. EFFECTIVE THERAPY RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8543797 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED WEAKNESS IN THEIR ARMS AFTER PERMANENT CERVICAL IMPLANT DUE TO AN EPIDURAL HEMATOMA AT THE LEAD SITE. AS A RESULT, THE PATIENT WAS TAKEN BACK INTO THE OR WHERE THE HEMATOMA WAS EVACUATED AND THE ENTIRE SYSTEM EXPLANTED TO ADDRESS THE ISSUE. FOLLOW-UP REVEALED THE PATIENT RECOVERED AND THE ISSUE RESOLVED.

  Patient problems: Hematoma; Weakness

  MAUDE report 8096715 ↗
• InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT RECEIVED UNDESIRED RIB STIMULATION FROM THE SCS SYSTEM. AS SUCH, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6)2018, WHEREIN THE LEAD WAS REPOSITIONED. REPORTEDLY, EFFECTIVE STIMULATION WAS RESTORED FOLLOWING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7765509 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT FELL, AND THEN BEGAN EXPERIENCING SHOCKING SENSATIONS WHILE STIMULATION WAS TURNED ON. IT WAS DISCOVERED THE LEAD MOVED LATERALLY. THE PATIENT REQUESTED THE SCS SYSTEM BE EXPLANTED, SO THE PHYSICIAN EXPLANTED THE SYSTEM.

  Patient problems: Device Overstimulation of Tissue; Fall

  MAUDE report 7679623 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT FELL AND AS A RESULT, THE PATIENT'S LEAD MIGRATED AND THE PATIENT BEGAN TO EXPERIENCE TENDERNESS AT THE LEAD SITE. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED.

  Patient problems: Fall; Pain

  MAUDE report 7670461 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS EXPERIENCING UNINTENDED RADICULAR RIB PAIN AND HAS BEEN EXPERIENCING THIS SINCE IMPLANTATION. THIS PAIN WAS SUSPECTED TO BE DUE TO THE LEAD BEING TOO LARGE FOR THE EPIDURAL SPACE. THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THE LEAD WAS REMOVED AND REPLACED WITH A SMALLER LEAD. THE ISSUE HAS BEEN RESOLVED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7641630 ↗

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-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-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-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-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-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-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