Lamitrode™ 3240Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05414734406192), received between Jan 21, 2020 and Nov 7, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “High impedance” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENTS LEAD WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 20636026 ↗
• InjuryNov 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENTS LEAD WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 20636004 ↗
• InjuryJun 12, 2023High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-02821. IT WAS REPORTED THAT SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113937 ↗
• InjuryJun 12, 2023High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2023-02822. IT WAS REPORTED THAT SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113929 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S LEAD HAD ERODED THROUGH THE SKIN. IN TURN, THE SYSTEM WAS EXPLANTED IN (B)(6) 2020 TO ADDRESS THE ISSUE. EXACT DATE OF EXPLANT UNKNOWN.

  Patient problems: Erosion

  MAUDE report 11769574 ↗
• InjuryMay 29, 2020High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21178; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21180; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21181. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON MULTIPLE CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2020 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. ISSUE RESOLVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10102914 ↗
• InjuryMay 29, 2020High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21179; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21180; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21181. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON MULTIPLE CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2020 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. ISSUE RESOLVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10102905 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REPORT NUMBER: 3006705815-2020-00975; RELATED MANUFACTURING REPORT NUMBER: 1627487-2020-02294; RELATED MANUFACTURING REPORT NUMBER: 1627487-2020-02295; RELATED MANUFACTURING REPORT NUMBER: 1627487-2020-02296; RELATED MANUFACTURING REPORT NUMBER: 1627487-2020-02298; RELATED MANUFACTURING REPORT NUMBER: 1627487-2020-02299. IT WAS REPORTED THAT THE PATIENT HAD NUMEROUS STAPH INFECTIONS NEAR OR AT THE IPG AND INCISION SITES. THE PATIENT ALSO REPORTED VARIOUS RASHES. IT WAS DETERMINED THAT THE PATIENT WAS ALLERGIC TO THE IPG AND/OR LEADS. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ENTIRE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Rash; Unspecified Infection

  MAUDE report 9788531 ↗
• InjuryJan 21, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBERS 1627487-2020-00584, 1627487-2020-00586, 1627487-2020-00587, 1627487-2020-00589, 1627487-2020-00590, 1627487-2020-00591. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9610856 ↗
• InjuryJan 21, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBERS 1627487-2020-00584, 1627487-2020-00585, 1627487-2020-00587, 1627487-2020-00589, 1627487-2020-00590, 1627487-2020-00591. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9610852 ↗

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-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-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