Lamitrode® 3266Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734402170), received between Feb 5, 2020 and May 21, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT¿S LEAD WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863990 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-22527; RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-22528; RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-22529. IT WAS REPORTED THE PATIENT STATED HE EXPERIENCED UNCOMFORTABLE STIMULATION. PATIENT STATED PHYSICIAN IMPLANTED LEADS IN A DIFFERENT LOCATION THAN THE LOCATION USED FOR THE TRIAL AND HE FEELS PAIN. PATIENT SAID HE HAD A LEAD REVISION PROCEDURE (DATE NOT PROVIDED), BUT THE ISSUE PERSISTED. PATIENT DESIRES TO HAVE THE SYSTEM REMOVED. AN ABBOTT REPRESENTATIVE CONTACTED THE PATIENT AND INDICATED THE SYSTEM APPEARS TO BE NONFUNCTIONAL AND THAT THE PATIENT¿S PHYSICIAN DOES NOT PLAN TO REMOVE THE SYSTEM AT THIS TIME DUE TO PATIENT¿S HEALTH CONDITIONS. PATIENT PLANS TO CONSULT WITH ANOTHER PHYSICIAN.

  Patient problems: Discomfort; Inadequate Pain Relief; Pain

  MAUDE report 10242595 ↗
• InjuryFeb 5, 2020Inappropriate/Inadequate Shock/Stimulation; Unintended Electrical Shock; Inappropriate/Inadequate Shock/Stimulation; Unintended Electrical Shock

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-01167, 1627487-2020-01168. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION. AS A RESULT, SURGICAL INTERVENTION OCCURRED TO EXPLANT AND REPLACE THE LEADS AND EXTENSION. THE EXACT SURGERY DATE IS NOT KNOWN. THE PATIENT ALSO HAD ANOTHER SURGERY DUE TO A SHOCKING SENSATION, DOCUMENTED IN RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-01164, 1627487-2020-01165.

  Patient problems: Electric Shock; Undesired Nerve Stimulation

  MAUDE report 9672264 ↗
• InjuryFeb 5, 2020Inappropriate/Inadequate Shock/Stimulation; Unintended Electrical Shock; Inappropriate/Inadequate Shock/Stimulation; Unintended Electrical Shock

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-01166. 1627487-2020-01168. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION. AS A RESULT, SURGICAL INTERVENTION OCCURRED TO EXPLANT AND REPLACE THE LEADS AND EXTENSION. THE EXACT SURGERY DATE IS NOT KNOWN. THE PATIENT ALSO HAD A SYSTEM EXPLANT DUE TO A SHOCKING SENSATION, DOCUMENTED IN RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-01164, 1627487-2020-01165.

  Patient problems: Electric Shock; Undesired Nerve Stimulation

  MAUDE report 9672238 ↗

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-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-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-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-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