Lamitrode™ 3286 (UDI 05415067017833)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05415067017833), received between Jun 21, 2018 and Mar 8, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “High impedance” (7 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN LEADS WERE REPLACED TO ADDRESS THE ISSUE. IT CANNOT BE DETERMINED WHICH LEAD CONTRIBUTED TO THE EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24541778 ↗
• InjuryJun 7, 2024Fracture; Fracture

  IT WAS REPORTED PATIENT'S IPG HAD REACHED END OF LIFE. AS A RESULT, PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 TO ADDRESS THE ISSUE, IT WAS DETERMINED THAT THE LEAD BOKE/ FRACTURED DUE TO UNTANGLING LOOPS THAT HAD SCAR TISSUE SET IN. AS A RESULT, THE PATIENT'S IPG AND LEAD WERE REPLACED. THE IPG SITE WAS ALSO REPOSITIONED PER PATIENT'S REQUEST. THERAPY WAS RESTORED.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19482736 ↗
• InjuryDec 4, 2023High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S LEAD WAS EXPLANTED AND REPLACEDON (B)(6) 2023.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 18253847 ↗
• InjuryNov 9, 2023Migration; Migration

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-05316. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING INEFFECTIVE RELIEF. THE PATIENT'S LEADS WERE NOTED TO HAVE MIGRATED AND THE LEADS HAD HIGH IMPEDANCE ON MULTIPLE CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE PATIENT'S LEADS WERE EXPLANTED, REPLACED, AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18102749 ↗
• InjuryJan 24, 2023Migration; Migration

  IT WAS REPORTED THE PATIENT'S LEAD HAD MIGRATED. SURGICAL INTERVENTION MAY OCCUR LATER TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16235047 ↗
• InjuryJan 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-05695. IT WAS REPORTED THAT THE PATIENT'S LEAD WAS EXPLANTED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16195573 ↗
• InjuryNov 14, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15786477 ↗
• InjuryOct 31, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-05790 AND 1627487-2022-05789) A PORTION OF THE LEAD ONE OF THE 2 LEADS REMAINED IMPLANTED IN THE PATIENT . ADDITIONAL SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN REMAINING PORTION OF LEAD WAS EXPLANTED. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WITH ALL ISSUES BEING RESOLVED.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700733 ↗
• InjuryOct 24, 2022High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-05789. IT WAS REPORTED THE PATIENTS SYSTEM WOULD NOT ENTER MRI MODE DUE TO HIGH IMPEDANCE VALUES ON THE LEADS. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN IN (B)(6) 2022 WHEREIN THE SYSTEM WAS EXPLANTED. EXACT DATE OF EXPLANT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657591 ↗
• InjuryJul 7, 2022Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; Insufficient Device Problem Information

  IT WAS REPORTED THAT X-RAY REVEALED THAT THE PATIENT'S 3286 LEAD WAS CUT AND LEFT IMPLANTED, BUT IS INACTIVE. IT IS UNKNOWN WHEN THE LEAD WAS CUT AND FOR WHAT REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14949015 ↗
• InjuryJul 5, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNRELATED IPG REPLACEMENT PROCEDURE ON (B)(6) 2022, IT WAS NOTED THAT PATIENT'S PADDLE LEAD WAS DAMAGED SO THE PROCEDURE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911906 ↗
• InjuryDec 15, 2021Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED INDICATES THE PARTIAL LEAD WAS EXPLANTED AND REPLACED WITH TWO LEADS. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13010027 ↗
• InjuryDec 14, 2021Migration; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATES THE LEAD WAS EXPLANTED AND REPLACED WITH TWO LEADS. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13001843 ↗
• InjuryApr 1, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING INEFFECTIVE THERAPY DUE TO LEAD MIGRATION. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11606258 ↗
• InjuryOct 5, 2020High impedance; High impedance

  IT WAS REPORTED DIAGNOSTICS INDICATED HIGH IMPEDANCE READINGS ON 12 OUT THE 16 LEAD CONTACTS. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10628158 ↗
• InjuryFeb 27, 2020High impedance; Migration; High impedance; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMPEDANCE READING SHOWED HIGH IMPEDANCES. X-RAY INDICATED THAT THE LEAD MIGRATED FROM MIDDLE TO THE RIGHT SIDE OF THE EPIDURAL SPACE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2020 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9765257 ↗
• InjuryFeb 24, 2020Fracture; Material Separation; Fracture; Material Separation

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-01871. IT WAS REPORTED THAT THE PATIENT¿S IPG WAS INOPERABLE AND THE LEAD¿S CONTACT PLATE CAME OFF. ADDITIONALLY, DUE TO PATIENT¿S UNRELATED HEALTH CONDITION THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2020 ADDRESSING THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9745252 ↗
• InjuryDec 11, 2019High impedance; Therapeutic or Diagnostic Output Failure; High impedance; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN TO REPLACE THE LEAD.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9453691 ↗
• InjuryJun 27, 2019High impedance; High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2019 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. REPORTEDLY, ISSUE WAS RESOLVED AND THERAPY RESUMED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8739814 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S LEAD HAD MIGRATED WHICH WAS CONFIRMED VIA X-RAY. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6)2019 WHEREIN THE PATIENT¿S LEAD WAS REPOSITIONED ONLY. THERAPY HAS BEEN RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8735758 ↗
• InjuryJun 13, 2019Break; Break

  IT WAS REPORTED THAT DURING REPLACEMENT SURGERY ON (B)(6) 2019 THE TAIL OF THE LEAD BROKE UPON REMOVAL AND WAS LEFT IN PATIENT. PATIENT DECLINED REMOVAL OF TAIL THUS, NO INTERVENTION IS PLANNED AT THIS TIME. REPLACEMENT SURGERY WAS CAPTURED IN 1627487-2019-06758, 1627487-2019-06759, 1627487-2019-06760.

  Patient problems: Foreign Body In Patient

  MAUDE report 8697684 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06758, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06760. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. PATIENT NOW HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8689386 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MFR REPORT: 1627487-2019-03341. IT WAS REPORTED THAT THE PATIENT'S LEAD WAS CONFIRMED VIA X-RAY TO HAVE MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN ON (B)(6) 2019 TO HAVE BOTH LEADS REPOSITIONED. ISSUE WAS RESOLVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8413579 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT¿S 3286 LEAD MIGRATED. IN TURN, PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2019 WHEREIN THE LEAD WAS REPOSITIONED. REPORTEDLY, THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8406179 ↗
• InjuryDec 5, 2018Disconnection; Disconnection

  DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2018-12507, REFERENCE MFR REPORT: 1627487-2018-12718. IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION DUE TO INVALID IMPEDANCES. X-RAYS WERE TAKEN AND CONFIRMED ONE OF THE LEADS HAD PULLED OUT OF THE HEADER. SURGICAL INTERVENTION WAS TAKEN ON (B)(6) 2018 TO RECONNECT THE LEADS AND IPG. ISSUE HAS BEEN RESOLVED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 8135011 ↗

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-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-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-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