Lamitrode® 3246Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734402095), received between Feb 27, 2019 and May 14, 2021 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2021High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-02396. IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION AND DIAGNOSTICS INDICATED HIGH IMPEDANCES. DUE TO INEFFECTIVE THERAPY PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED, CAUSING THE IPG TO BECOME INOPERABLE. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SCS SYSTEM INCLUDING THE LEAD AND THE IPG WAS EXPLANTED AND REPLACED. THIS ADDRESSED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11828819 ↗
• InjuryDec 28, 2020High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-49229, 1627487-2020-49230. IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2020 TO ADDRESS AN INOPERABLE IPG ISSUE. (REFERENCE REG REPORT: 3006705815-2020-30556) DURING THE PROCEDURE, DIAGNOSTICS SHOWED HIGH IMPEDANCE ON MULTIPLE CONTACTS. IN TURN, THE PATIENT'S LEADS AND EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11076248 ↗
• InjuryDec 28, 2020High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-49229, 1627487-2020-49231. IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2020 TO ADDRESS AN INOPERABLE IPG ISSUE. (REFERENCE REG REPORT: 3006705815-2020-30556) DURING THE PROCEDURE, DIAGNOSTICS SHOWED HIGH IMPEDANCE ON MULTIPLE CONTACTS. IN TURN, THE PATIENT'S LEADS AND EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11076247 ↗
• InjuryNov 6, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBERS: 1627487-2020-33393, 3006705815-2020-32519. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE PERSISTED. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE SYSTEM WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10802292 ↗
• InjuryNov 6, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2020-33394, 3006705815-2020-32519. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE PERSISTED. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE SYSTEM WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10802288 ↗
• InjuryFeb 27, 2019High impedance; High impedance

  DEVICE 2 OF 2. REFERENCE MFR. REPORT# 1627487-2019-02519, 1627487-2019-02521(DEVICE MIGRATION). IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE LEAD AND EXTENSION DURING INTRA-OPERATIVE TESTING AFTER AN IPG REPLACEMENT. THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED TO ADDRESS THE HIGH IMPEDANCE. IT WAS REPORTED THAT EFFECTIVE THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8376421 ↗

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-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-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