Lamitrode® 3244Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 05414734402071), received between Mar 1, 2019 and Apr 22, 2026 — classified as 36 injuries, 1 malfunction.

The most frequently reported specific device problem is “High impedance” (15 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE CERVICAL LEAD. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24956931 ↗
• InjuryMar 30, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON THE LEADS. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, EFFECTIVE THERAPY WAS RESTORED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24730246 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION WAS SUSPECTED. AS A RESULT, SYSTEM WAS REMOVED IN THE SUMMER OF 2025 TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 24532139 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION WAS SUSPECTED. AS A RESULT, SYSTEM WAS REMOVED IN THE SUMMER OF 2025 TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 24532134 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. EXPLANT DATE IS UNKNOWN. INFECTION HAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 23606819 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. EXPLANT DATE IS UNKNOWN. INFECTION HAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 23606817 ↗
• InjuryNov 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON AN UNKNOWN DATE WHEREIN THE CERVICAL LEAD WAS EXPLANTED FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 23526826 ↗
• InjuryJun 20, 2025High impedance; High impedance

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH EXTENSIONS AND A LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE EXTENSIONS AND LEAD WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD WAS IMPEDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22299583 ↗
• InjuryMay 23, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT PATIENTS LEAD HAD HIGH AND LOW IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081281 ↗
• InjuryMay 14, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION AT THE PADDLE SITE WHEN TURNING THE DEVICE ON. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED/CONTRIBUTED TO THE EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 22021592 ↗
• InjuryMay 7, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT'S IPG WAS STICKING OUT DUE TO WEIGHT LOSS, CAUSING PATIENT DISCOMFORT AT THE IPG SITE. PATIENT ALSO EXPERIENCED INEFFECTIVE STIMULATION WITH THE SCS SYSTEM. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21980300 ↗
• InjuryApr 23, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED PATIENT'S LEADS EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21896658 ↗
• InjuryNov 13, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES AND LEADS HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. YEARS FOUND PRIOR REPORT(S) ON THIS PATIENT: (B)(6).

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 20679965 ↗
• InjurySep 22, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. IT WAS NOTED THAT THEIR LEAD HAD HIGH IMPEDANCES ON ALL CONTACTS. AS A RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 20276284 ↗
• InjurySep 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. X-RAY SHOWED THE LEAD PULLED OUT. AS A RESULT, SURGICAL INTERVENTION OCCURRED ON (B)(6) 2024 DURING WHICH THE SYSTEM WAS UNABLE TO RECONNECT/PLUG BACK IN; THEREFORE, THE ENTIRE SYSTEM WAS REPLACED. THERAPY WAS RESTORED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20239180 ↗
• InjuryFeb 19, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND THE LEAD WAS LEFT IMPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18730575 ↗
• InjuryJan 25, 2024Therapeutic or Diagnostic Output Failure; Migration; Therapeutic or Diagnostic Output Failure; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO THE LEADS BEING PLACED AT ANOTHER LEVEL. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18584059 ↗
• InjuryJan 2, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION IS PLANNED TO REPLACE THE LEAD.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 18431661 ↗
• InjuryDec 7, 2023Migration; Migration

  ADDITIONAL INFORMATION INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHERE AN ADDITIONAL LEAD WAS ADDED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18288879 ↗
• InjuryMay 31, 2023High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-02571. IT WAS REPORTED THAT BOTH OF THE PATIENT'S LEADS HAD HIGH IMPEDANCES AS A RESULT THE PATIENT LOST EFFECTIVE THERAPY. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17035656 ↗
• InjuryDec 28, 2022Migration; Migration

  IT WAS REPORTED THE PATIENT¿S LEAD HAD MIGRATED. THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2022 WHERE THE WHOLE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16062298 ↗
• InjurySep 6, 2022High impedance; High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE IPG WAS ELECTIVELY REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15361879 ↗
• InjuryApr 13, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENTS SYSTEM IS NOT PROVIDING EFFECTIVE THERAPY. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14105947 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES SURGERY TOOK PLACE ON (B)(6) 2022 WHEREIN THE SECOND LEAD WAS EXPLANTED DUE TO THE LEAD ERODING THROUGH THE SKIN. THE SYSTEM WAS REPLACED. THE IPG WAS ELECTIVELY REPLACED.

  Patient problems: Erosion

  MAUDE report 12840440 ↗
• InjuryOct 22, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE THERAPY DUE TO HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION OCCURRED ON (B)(6) 2021 AND THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT HAS EFFECTIVE THERAPY POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12681934 ↗

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-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-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-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-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