Lamitrode Tripole™ 3219 (UDI 05414734401821)Recalls & reported problems

Summary

The FDA's MAUDE database contains 270 adverse event reports that list this exact device (DI 05414734401821), received between Jun 26, 2018 and Sep 29, 2026 — classified as 1 death, 268 injuries, 1 malfunction.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (74 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 25 most recent of 270 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported the patient experienced shocking. As a result the system was explanted to address the issue.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 50932099 ↗
• InjurySep 22, 2026High impedance

  It was reported that during the Normal End of Life IPG replacement on (b)(6) 2026 impedances were found on the existing lead. As a result, the lead was also replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50858832 ↗
• InjuryJul 31, 2026High impedance

  Additional information received indicates that patient was unable to set the system into MRI mode due to the high impedance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100411 ↗
• InjuryJul 28, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient experienced ineffective therapy. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50063823 ↗
• InjuryJul 27, 2026Therapeutic or Diagnostic Output Failure

  It was reported that following recent weight loss, the patient experienced pain and an itching sensation at the IPG site. Additionally, the patient experienced ineffective therapy. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50047706 ↗
• InjuryJul 27, 2026High impedance

  It was reported that the patient experienced ineffective stimulation due to high impedances. As a result, surgical intervention was undertaken on (b)(6)2026 wherein the lead was explanted and replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50024496 ↗
• InjuryJun 11, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25474485 ↗
• InjuryJun 5, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. LEAD FRACTURE WAS CONFIRMED VIA IMAGING. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS CONFIRMED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25412926 ↗
• InjuryMay 8, 2026Therapeutic 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 WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25124591 ↗
• InjuryApr 15, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED PATIENT WAS FEELING TINGLING IN THEIR STOMACH THAT WAS MAKING THEM SICK WHEN THERAPY WAS ON. PROGRAMMING WAS NOT ABLE TO RESOLVE THE ISSUE AND THERAPY WAS TURNED OFF. NEXT COURSE OF ACTION IS UNDETERMINED AT THIS TIME.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 24891883 ↗
• InjuryApr 6, 2026Patient-Device Incompatibility; No Apparent Adverse Event

  ADDITIONAL INFORMATION INDICATES THE LEADS WERE REPLACED ELECTIVELY FOR MRI CAPABILITY. THERE IS NO DEVICE MALFUNCTION; THEREFORE, THIS DEVICE IS NO LONGER CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791936 ↗
• InjuryMar 25, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD SIDE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS TUNNELED DEEPER. DURING THE PROCEDURE IT WAS NOTED THAT THE LEAD WAS COILED UP. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Implant Pain

  MAUDE report 24688694 ↗
• InjuryMar 24, 2026High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24683207 ↗
• InjuryMar 3, 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 24500919 ↗
• InjuryMar 2, 2026Migration

  IT WAS REPORTED THAT FOLLOWING A CAR ACCIDENT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24489730 ↗
• InjuryMar 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT¿S IPG AND LEAD WERE EXPLANTED. THE DATE OF EXPLANT AND REASON FOR EXPLANT ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24483935 ↗
• InjuryFeb 20, 2026Use of Device Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED COMPLICATIONS AT THE IPG POCKET SITE. THE IPG WAS EXPLANTED AND THE PADDLE LEAD WAS CUT AND PARTIAL REMAINED IMPLANTED. DATE OF SURGERY AND COMPLICATIONS ARE UNKNOWN. ON (B)(6) 2026 THE PHYSICIAN REMOVED THE CUT LEAD AND REPLACED THE SYSTEM. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24400186 ↗
• InjuryFeb 16, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A SYSTEM EXPLANT PROCEDURE ON (B)(6) 2016 [RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2016-04418], THE LEAD WAS CUT AND A PORTION OF THE LEAD REMAINS IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24348617 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE ANCHOR SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ANCHORS WERE EXPLANTED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Implant Pain

  MAUDE report 24059631 ↗
• InjuryJan 7, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH 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 23995476 ↗
• InjuryDec 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE ON (B)(6) 2025, PATIENTS LEAD WAS CUT, AND THE REMAINING PORTION OF THE LEAD REMAINS IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN ON A LATER DATE TO REMOVE REMAINING PORTION OF THE LEAD.

  Patient problems: Foreign Body In Patient

  MAUDE report 23908683 ↗
• InjuryDec 24, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026, WHEREIN THE REMAINING PORTION OF THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23890746 ↗
• InjuryDec 18, 2025High impedance; High impedance

  IT WAS REPORTED PATIENT'S LEAD HAS INVALID IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839370 ↗
• InjuryDec 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832687 ↗
• InjuryDec 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23811376 ↗

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-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-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-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-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-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