Lamitrode Tripole™ 3214 (UDI 05414734401784)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 05414734401784), received between Oct 2, 2018 and Sep 22, 2026 — classified as 61 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (24 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 61 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Low impedance

  It was reported that the patient's lead exhibited low impedances. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849882 ↗
• InjuryJun 23, 2026High impedance

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25589431 ↗
• InjuryFeb 10, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING AN IPG REPLACEMENT ON (B)(6) 2026 ONE END OF THE LEAD WAS ACCIDENTLY CUT. ADDITIONALLY, THE OTHER END OF THE LEAD WAS PULLED OUT OF THE IPG WITHOUT THE HEADER BEING LOOSENED. AS RESULT, AFTER THE IPG WAS REPLACED THE NON-CUT END OF THE LEAD WAS INSERTED INTO THE NEW IPG TO ADDRESS THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24310332 ↗
• InjuryNov 13, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED LOW IMPEDANCES. 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 23539707 ↗
• InjurySep 9, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THE THORACIC LEAD. THE PATIENT'S IPG WOULD NOT COMMUNICATE WITH EXTERNAL DEVICES AND WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23011681 ↗
• InjurySep 9, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23000405 ↗
• InjuryJul 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN IPG REPLACEMENT ON (B)(6) 2025, THE PHYSICIAN CUT ONE LEG OF THE PADDLE LEAD DURING THE PROCEDURE. THE LEAD REMAINS IMPLANTED IN THE PATIENT. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22527051 ↗
• InjuryMar 24, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO A COMBINATION OF HIGH AND LOW IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 TO REPLACE THE LEAD. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 21682963 ↗
• InjuryMar 3, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING INEFFECTIVE THERAPY AND ELECTRIC SHOCKS WHEN TOUCHING THINGS, PATIENTS LEAD HAS HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief; Undesired Nerve Stimulation

  MAUDE report 21511423 ↗
• InjuryJan 6, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEAD WAS EXPLANTED FOR AN UNKNOWN REASON AT AN UNKNOWN DATE SEVERAL YEARS AGO.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21088416 ↗
• InjuryDec 6, 2024Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES DIAGNOSTICS SHOWED LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20869367 ↗
• InjuryNov 20, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD MIGRATED. MIGRATION WAS CONFIRMED VIA X-RAY IMAGING. AS A RESULT, THE LEAD WAS REPLACED VIA SURGICAL INTERVENTION ON (B)(6) 2024. THERAPY WAS RESTORED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20737674 ↗
• InjuryOct 23, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE IPG SITE AND INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY TAKE PLACE TO EXPLANT THE SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20514895 ↗
• InjurySep 11, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT'S LEADS HAD MIGRATED. THE ISSUE WAS CONFIRMED VIA X-RAYS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20196000 ↗
• InjuryJul 3, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED, THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19667525 ↗
• InjuryMay 23, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT EXPERIENCED DIMINISHED/LOSS OF THERAPY DUE TO HIGH IMPEDANCES ON ALL CONTACTS. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19389199 ↗
• InjuryMay 10, 2024Impedance Problem; Impedance Problem

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

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

  MAUDE report 19294288 ↗
• InjuryMar 29, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THE SCS SYSTEM. PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 DURING WHICH AN ADDITIONAL DRG SYSTEM WAS IMPLANTED. BOTH SYSTEMS ARE PROVIDING PATIENT THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19005425 ↗
• InjuryFeb 12, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE DUE TO INEFFECTIVE PAIN RELIEF AND NEED FOR AN MRI.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18692052 ↗
• InjuryFeb 5, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY/COVERAGE DUE TO HIGH IMPEDANCES ON THE LEAD. REPROGRAMMING WAS UNABLE TO ACHIEVE ADEQUATE THERAPY. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 18644513 ↗
• InjurySep 22, 2023High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUES. REPORTEDLY, THE PATIENT STOPPED CHARGING THE IPG, RENDERING THE IPG INOPERABLE. EFFECTIVE THERAPY WAS RESTORED POST OP.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 17798851 ↗
• InjurySep 8, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER 1627487-2023-04251. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXISTING LEADS WERE EXPLANTED AND REPLACED RESTORING THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17714542 ↗
• InjuryJun 16, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION IS PENDING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17141439 ↗
• InjuryApr 16, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED. EXACT EXPLANT DATE IS UNKNOWN, SYSTEM WAS EXPLANTED APPROXIMATELY SOMETIME IN 2019.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16748803 ↗
• InjuryMar 15, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS AUTOREDUCING DUE TO HIGH IMPEDANCES. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED, RESOLVING THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16542713 ↗

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-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-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-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-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-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