Lamitrode™ 3245 (UDI 05414734406222)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05414734406222), received between Mar 28, 2019 and Mar 6, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE SYSTEM WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY. IT IS UNKNOWN WHICH LEAD CAUSED THE INEFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24536472 ↗
• InjuryFeb 19, 2026Therapeutic or Diagnostic Output Failure

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 24392958 ↗
• InjuryDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEAD WAS FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23821810 ↗
• InjuryMar 24, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM AND DISCOMFORT AT THE IPG SITE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. NOTE : IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21681633 ↗
• InjuryNov 2, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-07077. IT WAS REPORTED THAT THE PATIENT'S BATTERY WAS DEAD, AND THE PATIENT NEVER GOT GOOD PAIN RELIEF. IT IS UNKNOWN IF THE DEVICE DEPLETED PREMATURELY. SURGICAL INTERVENTION TOOK PLACE WHERE THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. THE ALLEGATION IS AGAINST [1] OF [2] [LEAD]; HOWEVER, IT IS UNKNOWN WHICH [LEAD(S)], THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: 3163, UDI: (B)(4), SERIAL: (B)(6), BATCH: 4907485.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18062409 ↗
• InjuryJul 11, 2023High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2023-04283. IT WAS REPORTED THE DEVICE DISPLAYED THE END OF SERVICE (EOS) MESSAGE AND IT IS UNKNOWN IF THE DEVICE DEPLETED PREMATURELY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG AND LEAD WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17302458 ↗
• InjuryFeb 4, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-00904. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-00907. IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, TO ADDRESS THE ISSUE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEADS AND IPG WERE EXPLANTED AND REPLACED WITH A NEW PENTA LEAD AND IPG. REPORTEDLY EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11282216 ↗
• InjuryDec 14, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT HAD INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE IN WHICH THE LEAD WAS REPLACED WITH A DIFFERENT MODEL AND RELOCATED FOR BETTER COVERAGE. THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11004630 ↗
• InjuryNov 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REPORT NUMBERS 1627487-2020-33305, 1627487-2020-33306. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED AND REPLACED WITH A COMPETITOR SYSTEM ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. FURTHER INFORMATION IS CURRENTLY UNAVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10788098 ↗
• InjuryJul 18, 2020Inappropriate/Inadequate Shock/Stimulation; Therapeutic or Diagnostic Output Failure; Inappropriate/Inadequate Shock/Stimulation; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-22834; 1627487-2020-22836. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE AND PAINFUL THERAPY. AS A RESULT, SURGERY OCCURRED TO EXPLANT THE SYSTEM ON AN UNKNOWN DATE.

  Patient problems: Inadequate Pain Relief; Undesired Nerve Stimulation

  MAUDE report 10293494 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-22832. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS FROM THE WASTE DOWN FOLLOWING THE SYSTEM IMPLANT. AS A RESULT, SURGERY OCCURRED ON AN UNKNOWN DATE TO EXPLANT THE LEADS.

  Patient problems: Numbness

  MAUDE report 10285944 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2019-08183, 1627487-2019-08185. IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION. SURGERY MAY OCCUR TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8801067 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2019-02053. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2019, WHEREIN THE IPG AND LEAD WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8685480 ↗
• InjuryMar 28, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING AN IPG SURGERY (REFERENCE MFR REPORT 1627487-2019-03953). THE LEAD WAS FRACTURED AT T10. AS A RESULT, THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED. PATIENT NOW HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8459967 ↗

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-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-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-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-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-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