Lamitrode® 3288Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 05414734402248), received between Sep 26, 2018 and Jan 12, 2026 — classified as 57 injuries, 1 malfunction.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (17 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026High impedance

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEAD HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. PATIENTS IPG WAS ALSO EXPLANTED AND REPLACED FOR AN UNKNOWN REASON.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24048398 ↗
• InjuryDec 5, 2025High impedance; High impedance

  IT WAS REPORTED PATIENT WAS UNABLE TO SET THE IPG INTO MRI MODE DUE TO HIGH IMPEDANCE ON ONE OF THE LEADS, IT IS UNKNOWN WHICH LEAD ATTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730328 ↗
• InjuryJul 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT FOLLOWING JIU JITSU PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEAD HAS HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN PATIENTS' SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22594290 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT PROCEDURE ON (B)(6) 2025, THE PATIENT SUSTAINED A DURAL TEAR. AS A RESULT, THE TEAR WAS SUTURED DURING THE PROCEDURE TO ADDRESS THE ISSUE. THE PATIENT EXPERIENCED A HEADACHE POST OP. PATIENTS IS STABLE AND SYMPTOMS HAVE RESOLVED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 22487175 ↗
• InjuryDec 30, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 THAT IDENTIFIED NO CONNECTION ISSUE. NO INTERVENTION WAS UNDERTAKEN DURING THE PROCEDURE WITH THE DEVICES AND ALL DEVICES REMAIN IMPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21044643 ↗
• InjuryDec 5, 2024Impedance Problem; Impedance Problem

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

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 20856742 ↗
• InjuryJul 22, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY AND DISCOMFORT AT THE IPG SITE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE IPG AND LEAD WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19796928 ↗
• InjuryMar 29, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THE SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE SCS IPG WAS EXPLANTED AND A DRG SYSTEM WAS IMPLANTED. THE SCS LEAD REMAINS IMPLANTED BUT INACTIVE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19004315 ↗
• InjuryFeb 6, 2024High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2024-00879. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS SUCH, SURGICAL INTERVENTION WAS TAKEN AND THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18651527 ↗
• InjuryNov 1, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE LAMITRODE LEAD WAS EXPLANTED AND REPLACED WITH A PENTA LEAD TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18049473 ↗
• InjuryJul 11, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 WHEREIN, THE LEAD WAS EXPLANTED AND REPLACED, THE IPG WAS ALSO RELOCATED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17302587 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DOCTOR HAS INDICATED THAT THE INFECTION HAS CLEARED AND IV ANTIBIOTICS HAVE BEEN STOPPED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17035008 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 72 HOURS FOLLOWING A PERMANENT IMPLANT PROCEDURE, THE PATIENT EXPERIENCED AN EXTRADURAL HEMATOMA AFTER STRAINING TO EVACUATE THEIR BOWELS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHERE IN THE ENTIRE SYSTEM WAS EXPLANTED. CURRENTLY, THE PATIENT HAS COMPLETE LOSS OF LOWER LIMB MOTOR FUNCTION AND SIGNIFICANT LOSS OF SENSORY FUNCTION.

  Patient problems: Hematoma; Paralysis

  MAUDE report 16710657 ↗
• InjuryApr 3, 2023Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2023-01812. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO LEAD MIGRATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. THE IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICES AFTER THE PROCEDURE AND WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16665414 ↗
• InjuryFeb 9, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THE PATIENT WAS EXPERIENCING SHOCKING SENSATION. AS SUCH, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 16333943 ↗
• InjuryDec 18, 2022Disconnection; Migration; Disconnection; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06898. IT WAS REPORTED THAT X-RAYS SHOWED DISCONNECTION BETWEEN THE LEAD AND IPG. AS SUCH, THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. A MESSAGE WAS RECEIVED STATING THE IS AN OPEN CIRCUIT/HIGH IMPEDANCES. HOWEVER, IMPEDANCE CHECK REVELATED THAT THE IMPEDANCE IS IN NORMAL RANGE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16001459 ↗
• InjuryDec 7, 2022Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06689. IT WAS REPORTED THAT DURING AN IPG EXPLANT PROCEDURE THE PHYSICIAN CUT THE LEADS. THE CUT PORTION OF THE LEADS REMAIN IMPLANTED IN THE PATIENT. SURGICAL INTERVENTION MAY BE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934106 ↗
• InjuryNov 21, 2022High impedance; High impedance

  IT WAS REPORTED THE PATIENTS LEAD DISPLAYED HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15833316 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER:1627487-2022-05457. IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION POSSIBLY 6 WEEKS AFTER IMPLANT. REPORTEDLY, THE ENTIRE SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE AND THE PATIENT WAS HOSPITALIZED SEVERAL WEEKS TO TREAT THE INFECTION. THE INFECTION HAS BEEN RESOLVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15540280 ↗
• InjuryAug 1, 2022Fracture; Fracture

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. LEAD DIAGNOSTICS INDICATED HIGH IMPEDANCES ON ALL CONTACTS. REPROGRAMMING DID NOT RESOLVE THE ISSUE. X-RAY CONFIRMED LEAD FRACTURE AND THE LEADS ARE TANGLED IN THE IPG POCKET SITE. IN TURN, SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15137095 ↗
• InjuryJun 17, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IN TURN, THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14734493 ↗
• InjuryJun 3, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-03095. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14595243 ↗
• InjuryJun 3, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-03096. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14595236 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL PROCEDURE ON (B)(6) 2022 WHEREIN THE CERVICAL WOUND WAS WASHED OUT DUE TO POSTOPERATIVE INFECTION OR HEMATOMA.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 14495809 ↗
• InjuryNov 14, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. SURGERY OCCURRED TO EXPLANT AND REPLACE THE LEAD TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12808429 ↗

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-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-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-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-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-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-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