Lamitrode Tripole™ 3219 (UDI 05415067017628)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05415067017628), received between Dec 20, 2018 and Mar 11, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “High impedance” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026High impedance

  ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON 01 APRIL 2026 WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570159 ↗
• InjuryFeb 19, 2026High impedance

  IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE AND UNABLE TO ENTER MRI MODE DUE TO HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD AND IPG WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387359 ↗
• InjuryDec 12, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT'S LEAD WAS EXPLANTED AN REPLACED FOR AN UNKNOWN REASON.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23792707 ↗
• InjuryFeb 7, 2025High impedance; High impedance

  DIAGNOSTICS REVEALED HIGH IMPEDANCE. 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 21333915 ↗
• InjuryJan 9, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING PRIOR TO THE SURGERY THE PATIENT HAD HIGH IMPEDANCES. ALSO, SURGICAL INTERVENTION TOOK PLACE WHERE THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18475943 ↗
• InjuryOct 6, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING IMPEDANCES ISSUES. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17885361 ↗
• InjurySep 25, 2023High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE WHERE THE PATIENTS LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17807812 ↗
• InjuryJul 5, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT HAS BEEN GETTING NO THERAPY RELIEF. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17254941 ↗
• InjuryMay 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT'S LEADS WERE EXPLANTED AFTER BEING CUT DURING A PRIOR SURGERY. THE LEAD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022253 ↗
• InjuryMay 8, 2023High impedance; High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED UNDESIRED NERVE STIMULATION WITH THEIR SCS SYSTEM. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 16885102 ↗
• InjuryFeb 27, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON 8 MAR 2023 WHEREIN NEW LEAD WAS IMPLANTED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16449173 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION WAS PRESENT AT THE LEAD INSERTION SITE. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. PATIENT IS TO FOLLOW-UP WITH PHYSICIAN AS THE NEXT COURSE OF ACTION.

  Patient problems: Unspecified Infection

  MAUDE report 16108974 ↗
• InjuryJan 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00047. IT WAS REPORTED THAT PATIENT UNDERWENT SURGICAL INTERVENTION AT UNKNOWN DATE FOR UNKNOWN REASON WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 16092002 ↗
• InjuryDec 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT¿S LEAD WAS ACCIDENTALLY CUT DURING A PROCEDURE. IN TURN SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16042520 ↗
• InjuryDec 7, 2022Use of Device Problem; Impedance Problem; Use of Device Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT LEAD WAS ABANDONED AND LEFT IMPLANTED DURING A SYSTEM REVISION ON (B)(6) 2022. NO INTERVENTION IS PLANNED TO RETRIEVE THE LEAD.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15937244 ↗
• InjuryNov 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-06261. IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE PATIENT'S IPG WAS EXPLANTED AND REPLACED. IT WAS REPORTED THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 15819737 ↗
• InjuryOct 19, 2022Low impedance; Low impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-04989. IT WAS REPORTED THE PATIENT HAD EFFECTIVE THERAPY, BUT LOW IMPEDANCES ON CONTACTS 8-15. AS A RESULT, THE LEAD WAS REPLACED SO THE PATIENT COULD UTILIZE MRI MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635937 ↗
• InjuryJul 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCE ON ALL LEAD CONTACTS. AS A RESULT, SURGERY INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14977444 ↗
• InjuryMar 29, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-01608. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THE IMPLANTED LEAD AND THE IPG HAD REACHED END OF LIFE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG AND LEAD WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13940938 ↗
• InjuryNov 12, 2020Migration; Migration

  IT WAS REPORTED THAT PATIENT EXPERIENCED A FALL WHICH RESULTED TO LEAD MIGRATION. AS A RESULT THE SURGICAL INTERVENTION WAS UNDERTAKEN WHERE IN THE LEAD WAS EXPLANTED AND REPLACED ADDRESSING THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10827135 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2: REFERENCE MFR. REPORT: 3006705815-2019-00210. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE RELIEF. AS A RESULT, THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8246486 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2: REFERENCE MFR. REPORT# 3006705815-2018-03418. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION IN THE WRONG LOCATION. IN TURN, THE PATIENTS SYSTEM WAS EXPLANTED AND REPLACED. EFFECTIVE STIMULATION WAS CONFIRMED POST-OP.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8185731 ↗

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-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-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-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-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