Lamitrode™ 3245 (UDI 05414734402088)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05414734402088), received between Oct 17, 2018 and Dec 19, 2025 — classified as 31 injuries.

The most frequently reported specific device problem is “High impedance” (13 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD EXHIBITED HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851614 ↗
• InjuryJul 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THE THORACIC LEAD. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE LEAD. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD HAS HIGH IMPEDANCE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22563876 ↗
• InjuryMay 13, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22012767 ↗
• InjuryJul 24, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION AND UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE SYSTEM AS A RESULT. THE SYSTEM WAS EXPLANTED AT AN UNKNOWN TIME.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 19817315 ↗
• InjuryMay 24, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. PROGRAMMER DISPLAYED ERROR MESSAGE "STRENGTH IS OFF. THE GENERATOR COULD NOT DELIVER THE DESIRED STRENGTH." IMPEDANCES ISSUES WERE ADDRESSED, AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE AT LATER TIME

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19395599 ↗
• InjuryMay 24, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. PROGRAMMER DISPLAYED ERROR MESSAGE "STRENGTH IS OFF. THE GENERATOR COULD NOT DELIVER THE DESIRED STRENGTH." IMPEDANCES ISSUES WERE ADDRESSED, AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE AT LATER TIME

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19395588 ↗
• InjuryDec 22, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE LEAD. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18387153 ↗
• InjuryJun 14, 2023Migration; Migration

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-02414. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM AND THAT BOTH LEADS HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17131760 ↗
• InjuryFeb 2, 2023Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED STATING SURGICAL INTERVENTION TOOK PLACE WHERE THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. PER THE PATIENT'S AND PHYSICIAN DECISION. EFFECTIVE STIMULATION WAS RESTORED.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 16287081 ↗
• InjuryFeb 1, 2023High impedance; Migration; High impedance; Migration

  ADDITIONAL INFORMATION INDICATED THAT SURGICAL INTERVENTION WAS UNDERTAKEN WHERE IN THE LEAD WAS EXPLANTED AND REPLACED. ALL CONTACTS VALID AND PATIENT HAS BURST PROGRAMMING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16280643 ↗
• InjuryJan 24, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-00278. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDESIRED NERVE STIMULATION AND DISCOMFORT AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS LIABLE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 16238073 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-04167. IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN AT THE IPG AND LEAD SITES. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Implant Pain

  MAUDE report 15130965 ↗
• InjuryJul 1, 2022Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03698. IT WAS REPORTED THE PATIENT'S LEADS MIGRATED. THE ISSUE WAS CONFIRMED VIA X-RAY. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14883301 ↗
• InjuryJun 15, 2022High impedance; High impedance

  RELATED MANUFACTURER NUMBER: 1627487-2022-03408. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCE. SURGERY MAY TAKE PLACE LATER. IT IS UNKNOWN WHICH LEAD PRESENTS THE ISSUE, THEREFORE BOTH LEADS ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14708674 ↗
• InjuryApr 12, 2022High impedance; High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS DISCOVERED MULTIPLE CONTACTS WITH HIGH IMPEDANCE. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14088451 ↗
• InjuryJan 19, 2022High impedance; High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED DURING IPG REPLACEMENT (MANUFACTURER REPORT NUMBER 1627487-2021-18523). AS A RESULT, FURTHER SURGICAL INTERVENTION OCCURRED WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13292347 ↗
• InjuryDec 3, 2021High impedance; High impedance

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 12923807 ↗
• InjuryNov 30, 2021High impedance; High impedance

  IT WAS REPORTED THE PATIENT HAD HIGH IMPEDANCES AND WANTED IMPROVED COVERAGE. IN TURN, THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12897795 ↗
• InjuryMay 21, 2021Impedance Problem; Impedance Problem

  IT WAS REPORTED THE PATIENT HAS BEEN RECEIVING INADEQUATE THERAPY DUE TO HIGH AND LOW IMPEDANCE BEING PRESENT. REPROGRAMMING WAS PERFORMED BUT WAS UNABLE TO PROVIDE RESOLUTION. AS A RESULT, THE PATIENT PLANS TO UNDERGO SURGICAL INTERVENTION ON A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11866483 ↗
• InjuryMay 17, 2021Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11839028 ↗
• InjuryFeb 10, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THE ELECTIVE IPG REPLACEMENT PROCEDURE THE PHYSICIAN COULDN'T GET THE TERMINAL END OF THE LEAD TO SEAT PROPERLY ON THE NEW IPG HEADER, AND FRACTURED THE LEAD WHILE TRYING TO INSERT IT INTO THE HEADER. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED RESOLVING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306775 ↗
• InjuryJan 14, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-00295 , 1627487-2021-00296. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IN TURN, THE SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11171502 ↗
• InjuryNov 16, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEAD WAS EXLANTED AND REPLACED. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10841934 ↗
• InjuryOct 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-33023. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-33025. IT WAS REPORTED THAT PATIENT UNDERWENT SURGICAL INTERVENTION FOR UNKNOWN REASON AT UNKNOWN DATE, WHEREIN THE LEADS AND IPG WERE EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10759742 ↗
• InjuryOct 1, 2020Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE ON MULTIPLE CONTACTS OF THE LEAD. REPROGRAMMING DID NOT RESOLVE THE ISSUE. SURGERY MAY OCCUR TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10617768 ↗

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-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-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-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-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-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