Lamitrode® 3268Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05414734402194), received between May 23, 2019 and Apr 21, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “High impedance” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD FRACTURED LEADS WITH HIGH IMPEDANCES. X-RAY IMAGING WAS DONE TO CONFIRM THE ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 21878002 ↗
• InjuryApr 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD FRACTURED LEADS WITH HIGH IMPEDANCES. X-RAY IMAGING WAS DONE TO CONFIRM THE ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 21877998 ↗
• InjurySep 25, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF ONE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD MIGRATED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20304542 ↗
• InjuryNov 4, 2022Material Fragmentation; Material Fragmentation

  RELATED MANUFACTURER REFERENCE NUMBER:3006705815-2022-17618. RELATED MANUFACTURER REFERENCE NUMBER:3006705815-2022-17865. IT WAS REPORTED THAT DURING A LEAD REVISION ON (B)(6) 2022 [RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-05732], A PORTION OF THE LEAD WAS UNABLE TO BE REMOVED DUE TO SCAR TISSUE. THE HEADER OF THE IPG WAS ALSO DAMAGED DURING THE PROCEDURE RESULTING IN THE REPLACEMENT OF THE IPG. ADDITIONALLY, THE PATIENT EXPERIENCED WEAKNESS IN THEIR LEFT HAND FOLLOWING THE PROCEDURE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN IN THE FUTURE TO ADDRESS THE ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15737481 ↗
• InjuryOct 31, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 WHEREIN THE LEAD WAS CUT, AND A NEW LEAD WAS PLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15700993 ↗
• InjurySep 24, 2022Disconnection; Disconnection

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-05224. IT WAS REPORTED X-RAYS WERE TAKEN AND SHOWED THAT 1 TAIL FROM A LEAD WAS DISCONNECTED FROM IPG HEADER. LEAD DIAGNOSTICS SHOWED THAT ALL IMPEDANCES WERE NORMAL. DURING REVISION SURGERY IT WAS CONFIRMED THAT ONE LEAD FROM THE 16 CHANNEL PADDLE IS BEING USED. IT WAS UNCLEAR AS TO WHETHER THE SECOND TAIL CONNECTED TO IPG HEADER IS FROM THE 8 CHANNEL LEAD OR 16 CHANNEL PADDLE LEAD. HOWEVER, THE SAME LEAD TAILS WERE INSERTED BACK INTO THE NEW IPG HEADER AND THE THIRD TAIL WAS LEFT UNPLUGGED. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481737 ↗
• InjuryAug 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03976, 1627487-2022-04653. IT WAS REPORTED THAT DURING AN IPG REPLACEMENT PROCEDURE (B)(6) 2022 THE PATIENT HAD A COMPETITORS BATTERY AND LEADS IMPLANTED. IT IS UNKNOWN WHEN OR WHY THE IPG AND LEADS BEING REPORTED WERE REPLACED FOR THE COMPETITORS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 15300558 ↗
• InjuryAug 17, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15244501 ↗
• InjuryJul 22, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS UNPLUGGED AND A NEW LEADS IMPLANTED FOR OPTIMAL COVERAGE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15089823 ↗
• InjuryJul 26, 2021High impedance; High impedance

  IT WAS REPORTED DURING THE PATIENT'S IPG REPLACEMENT (MANUFACTURER REFERENCE NUMBER: 1627487-2021-15704) THE LEAD WAS REPLACED DUE TO HIGH IMPEDANCES. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12225807 ↗
• InjuryJun 11, 2020No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  ADDITIONAL INFORMATION FOUND THAT PATIENT UNDERWENT A SCAR TISSUE REVISION SURGERY ON (B)(6) 2020. NO IMPLANTED PRODUCTS WERE TOUCHED OR EXPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10146434 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MANUFACTURER REPORT NUMBER: 1627487-2019-06617. REFERENCE MANUFACTURER REPORT NUMBER: 1627487-2019-06619. REFERENCE MANUFACTURER REPORT NUMBER: 1627487-2019-06621. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE PENDING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8678206 ↗
• InjuryMay 23, 2019High impedance; High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED A FALL AND AS A RESULT LOST STIMULATION. DIAGNOSTICS INDICATED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE CERVICAL LEAD. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Fall; Inadequate Pain Relief

  MAUDE report 8638212 ↗

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-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-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-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-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-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-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