Lamitrode Tripole™ 3219 (UDI 05414734406161)Recalls & reported problems

Summary

The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 05414734406161), received between Jun 29, 2018 and May 19, 2026 — classified as 1 death, 200 injuries.

The most frequently reported specific device problem is “High impedance” (56 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 201 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A PREVIOUS PROCEDURE WHEREIN THE SYSTEM WAS EXPLANTED, THE LEAD WAS CUT AND A PORTION OF THE LEAD REMAINED IMPLANTED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE REMAINING PORTION OF THE LEAD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224892 ↗
• InjuryMay 12, 2026Fracture

  IT WAS REPORTED THAT DURING AN IPG REPLACEMENT [RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2026-02604] ON (B)(6) 2026, THE LEAD WAS OBSERVED TO BE VISIBLY FRACTURED. 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 25153644 ↗
• InjuryApr 1, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026, WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757114 ↗
• InjuryFeb 27, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND NEEDED EXPANDED MRI CAPABILITY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE IPG WAS REPOSITIONED AS WELL AS REPLACED. DURING THE PROCEDURE THE EXISTING LEAD HAD A CONTACT WITH HIGH IMPEDANCES THAT WOULD NOT CLEAR, SO THE LEAD WAS REPLACED AS WELL TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474709 ↗
• InjuryJan 15, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER THEIR DEVICE INTO MRI MODE DUE TO HIGH IMPEDANCES ON THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086970 ↗
• InjuryJan 9, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2025 TO ADDRESS THE ISSUE. DURING IPG REPLACEMENT THE PATIENTS LEAD HAD A HIGH IMPEDANCE. AS A RESULT, THE LEAD WAS ALSO REPLACED ON (B)(6) 2025 TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027708 ↗
• InjuryNov 10, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET DISCOMFORT AT BOTH OF THE IPG SITES. THE PATIENT ALSO EXPERIENCED INEFFECTIVE THERAPY WITH THEIR LUMBAR SYSTEM, AND THE CERVICAL LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LUMBAR SYSTEM WAS EXPLANTED, AND THE CERVICAL LEAD AND IPG WERE EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23513963 ↗
• InjuryNov 7, 2025Migration; Migration

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO LEAD MIGRATION. IT WAS CONFIRMED VIA X-RAY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23495580 ↗
• InjuryNov 4, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE DUE TO IMPEDANCES. AS A RESULT, THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472241 ↗
• InjuryOct 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE ON (B)(6) 2025 [RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2025-05260, 1627487-2025-05261, 1627487-2025-05262], THE LEAD WAS CUT, AND PART OF THE LEAD REMAINS IMPLANTED IN THE PATIENT. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23410962 ↗
• InjuryOct 27, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMAGING REVEALED MIGRATION OF ONE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 TO REPLACE THE LEAD. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23397471 ↗
• InjuryOct 26, 2025Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AND PAIN AT THE EXTENSION SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG AND EXTENSIONS WERE EXPLANTED, AND THE LEAD WAS CUT AND LEFT IMPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23388131 ↗
• InjuryOct 24, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO IMPEDANCES ON THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23383344 ↗
• InjurySep 18, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER THEIR DEVICE INTO MRI MODE DUE TO HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23091495 ↗
• InjurySep 5, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER THEIR DEVICE INTO MRI MODE DUE TO HIGH IMPEDANCES ON THE THORACIC LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977760 ↗
• InjuryAug 28, 2025High impedance; High impedance

  IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO MULTIPLE HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22910197 ↗
• InjuryJul 2, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION AT UNKNOWN TIME WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED DUE TO PATIENT NEEDING MRI AND EXPERIENCING LOSS OF EFFECTIVE THERAPY WITH THE SCS SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22389657 ↗
• InjuryJun 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299507 ↗
• InjuryMay 24, 2025High impedance; Therapeutic or Diagnostic Output Failure; High impedance; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22082431 ↗
• InjuryMay 20, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, THE IPG WAS EXPLANTED VIA SURGICAL INTERVENTION. THE DATE OF SURGERY IS UNKNOWN. IT WAS CONFIRMED THAT THE PHYSICIAN DID NOT INTEND OR ATTEMPT TO REMOVE THE LEAD DURING THIS PROCEDURE. THE LEAD WAS LEFT IN THE ANATOMY WITH NO PLAN TO EXPLANT AT THIS TIME.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22055713 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATES THAT PATIENT'S WEIGHT WAS FLUCTUATING, AND PATIENT WAS EXPERIENCING NUMBNESS AND TINGLING DUE TO SPINAL CORD COMPRESSION. PATIENT ALSO EXPERIENCED PAIN 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 REPOSITIONED TO ADDRESS THE ISSUE. PATIENT SYMPTOMS ARE IMPROVING.

  Patient problems: Implant Pain; Numbness

  MAUDE report 20800947 ↗
• InjuryNov 21, 2024Migration; Migration

  IT WAS REPORTED IN MEDWATCH REPORT MW5160174 THAT PATIENT WAS EXPERIENCING PAIN AT LEAD SITE, X-RAY IMAGING REVEALED PATIENTS LEAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN PATIENTS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain; Inadequate Pain Relief

  MAUDE report 20748108 ↗
• InjuryNov 21, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED, THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. AS A RESULT, THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE. THE LEAD REMAINS IMPLANTED AT THIS TIME.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20746302 ↗
• InjuryOct 30, 2024Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 IN WHICH THE LEAD WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20570233 ↗
• InjuryOct 26, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN FLOATING LEAD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20540202 ↗

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-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-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-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-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-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-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-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