Lamitrode® 3286Recalls & reported problems

Summary

The FDA's MAUDE database contains 332 adverse event reports that list this exact device (DI 05414734402231), received between Jun 12, 2018 and May 27, 2026 — classified as 332 injuries.

The most frequently reported specific device problem is “High impedance” (125 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 332 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THE SYSTEM. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25309417 ↗
• InjuryApr 3, 2026High impedance

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 24783543 ↗
• 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 24731825 ↗
• InjuryMar 15, 2026High impedance

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24602004 ↗
• InjuryMar 15, 2026High impedance

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24602003 ↗
• InjuryFeb 20, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO PLACE THEIR SYSTEM INTO MRI MODE. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408002 ↗
• InjuryJan 16, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2026, WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24102877 ↗
• InjuryDec 2, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S HAS INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THEIR LEADS. FURTHER INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23696868 ↗
• InjuryDec 2, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S HAS INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THEIR LEADS. FURTHER INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23694602 ↗
• InjuryNov 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23606087 ↗
• InjuryNov 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23605794 ↗
• InjuryOct 31, 2025High impedance; High impedance

  IT WAS REPORTED PATIENT HAD HIGH IMPEDANCES ON THE LEAD AND STOPPED CHARGING THE IPG. PATIENT LOST EFFECTIVE STIMULATION AS A RESULT. TO ADDRESS THE ISSUE, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD AND IPG WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23442435 ↗
• InjuryOct 27, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAS HIGH IMPEDANCES ON THEIR LEADS. A PROCEDURE WAS ATTEMPTED ON (B)(6) 2025, AND A LEAD REVISION WAS UNABLE TO BE PERFORMED. FURTHER INTERVENTION MAY BE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393955 ↗
• InjuryOct 27, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAS HIGH IMPEDANCES ON THEIR LEADS. A PROCEDURE WAS ATTEMPTED ON (B)(6) 2025, AND A LEAD REVISION WAS UNABLE TO BE PERFORMED. FURTHER INTERVENTION MAY BE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393952 ↗
• InjuryOct 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THEIR LEAD AND LOST EFFECTIVE THERAPY. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23360363 ↗
• InjuryOct 15, 2025High impedance; High impedance

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23279988 ↗
• InjurySep 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN RADIATING DOWN THEIR ARM FOLLOWING THEIR IMPLANT. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE SYSTEM WAS EXPLANTED. THE PAIN IS NOW RESOLVED.

  Patient problems: Pain

  MAUDE report 22989437 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22973947 ↗
• InjuryAug 26, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT FOLLOWING RECENT WEIGHT LOSS, THE PATIENT EXPERIENCED PAIN AT THE IPG SITE AND INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 TO REPLACE THE IPG AND LEADS. IT IS UNKNOWN WHICH LEAD CAUSED THE INEFFECTIVE THERAPY. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22896725 ↗
• InjuryJul 31, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN IPG AND LEAD REVISION PROCEDURE ON (B)(6) 2025 [RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2025-05353 AND 1627487-2025-03732], ONE OF THE OCCIPITAL LEADS WAS CUT AND A PORTION OF THE LEAD REMAINS IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD ATTRIBUTED TO THIS ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 22683784 ↗
• InjuryJul 31, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND HAD AN OCCIPITAL LEAD WHICH MIGRATED AND PROTRUDED THROUGH THEIR SKIN. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE PHYSICIAN CUT THE LEAD, AND A PORTION OF THE LEAD REMAINS IMPLANTED. IT IS UNKNOWN WHICH LEAD ATTRIBUTED TO THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22683781 ↗
• InjuryJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON HE LEADS. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22667598 ↗
• InjuryJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON HE LEADS. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22667593 ↗
• InjuryJun 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY WITH THEIR SCS SYSTEM AFTER A FALL, STROKE AND FOOT SURGERY. DIAGNOSTICS INDICATES HIGH IMPEDANCES ON ONE OF THE LEADS. AS A RESULT, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22342984 ↗
• InjuryJun 16, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER MRI MODE DUE TO A HIGH IMPEDANCE ISSUE ON ONE LEAD. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED VIA SURGICAL INTERVENTION ON (B)(6) 2025. IT IS UNKNOWN WHICH LEAD CAUSED/CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213679 ↗

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-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-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-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-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