Lamitrode™ 3286 (UDI 05414734406291)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05414734406291), received between Jun 29, 2018 and Jan 2, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “High impedance” (12 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. IT WAS ALSO REPORTED THAT ONE OF THE PATIENT'S LEAD WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. FLUOROSCOPY IMAGING REVEALED MIGRATION OF THE REMAINING LEAD. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23952704 ↗
• InjuryFeb 20, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. DIAGNOSTIC TESTING REVEALED MULTIPLE IMPEDANCE ISSUES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY OCCURRED ON A LATER DATE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 21425650 ↗
• InjuryNov 13, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT PATIENTS LEADS HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

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

  MAUDE report 20679500 ↗
• InjuryOct 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENTS LEAD HAD HIGH IMPEDANCES, PATIENTS LEAD WAS FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 20518511 ↗
• InjurySep 26, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT¿S IPG INOPERABLE DUE TO REACHING END OF LIFE. ADDITIONALLY, THERE WAS HIGH IMPEDANCES. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS RESTORED POST OP.

  Patient problems: Failure of Implant

  MAUDE report 20316083 ↗
• InjuryAug 28, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS AUTOREDUCING. FURTHER INVESTIGATION REVEALED HIGH IMPEDANCES ON BOTH LEADS. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 20090822 ↗
• InjuryJun 26, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE, THE PHYSICIAN CUT A PORTION OF A LEAD. THE REMAINDER OF THE CUT LEAD REMAINS IN SITU. IT IS UNKNOWN WHICH LEAD WAS CUT. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19618399 ↗
• InjuryJan 15, 2024High impedance; High impedance

  IT WAS REPORTED PATIENT WAS EXPERIENCING SHOCKING SENSATION WHILE THERAPY WAS ON. DIAGNOSTICS INDICATED THAT ONE LEAD WAS EXHIBITING HIGH IMPEDANCE ON SOME CONTACTS. AS SUCH PATIENT IS PENDING SURGICAL INTERVENTION. INVESTIGATION WAS UNABLE TO DETERMINE WHICH LEAD WAS AT FAULT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 18515130 ↗
• InjuryDec 15, 2023Impedance Problem; Impedance Problem

  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 18339376 ↗
• InjuryNov 16, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS LIABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18154557 ↗
• InjurySep 26, 2023Migration; Migration

  ADDITIONAL INFORMATION INDICATED THAT EFFECTIVE THERAPY RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17822555 ↗
• InjurySep 8, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER 1627487-2023-04250. IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXISTING LEADS WERE EXPLANTED AND REPLACED RESTORING THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17714610 ↗
• InjuryAug 18, 2023Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03946. IT WAS REPORTED THAT THE LEADS HAD MIGRATED. AS SUCH, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17576978 ↗
• InjuryAug 18, 2023Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03945. IT WAS REPORTED THAT THE LEADS HAD MIGRATED. AS SUCH, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17576973 ↗
• InjuryJan 18, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16200310 ↗
• InjuryOct 7, 2022High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: 3006705815-2022-17206. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN, AND SCS SYSTEM WAS REPLACED. EFFECTIVE THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15566704 ↗
• InjurySep 12, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-05029. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. ATTEMPTS TO REPROGRAM WERE UNSUCCESSFUL. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15405821 ↗
• InjuryJul 20, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-04005. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. MULTIPLE ATTEMPTS TO REPROGRAM WERE UNSUCCESSFUL. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15067406 ↗
• InjuryApr 14, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IT WAS FOUND THAT THE LEAD HAD HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 TO INTERROGATE THE LEAD AND CONFIRMED HIGH IMPEDANCES ON THE LEAD AND ADDITIONAL SURGICAL INTERVENTION MAY TAKE PLACE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14111065 ↗
• InjuryFeb 28, 2022High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00935. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED. STIMULATION WAS RESTORED FOLLOWING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13618145 ↗
• InjuryJan 11, 2022High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-00194. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON BOTH LEADS. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13231284 ↗
• InjuryJan 11, 2022High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-00195. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON BOTH LEADS. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13231188 ↗
• InjuryNov 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REPORT NUMBER: 3006705815-2020-32522, 1627487-2020-33403, 1627487-2020-33404. IT WAS REPORTED THE PATIENT HAD THEIR SYSTEM EXPLANTED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10827080 ↗
• InjuryJul 20, 2020Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-22792, 3006705815-2020-02779. IT WAS REPORTED THAT THE PATIENT SUSTAINED A FALL WHICH LEAD TO LEAD MIGRATION. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ENTIRE SCS SYSTEM WAS EXPLANTED AND REPLACED. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10295519 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-02823, 1627487-2020-21241, 1627487-2020-21244, 1627487-2020-21245. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 10107250 ↗

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-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-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-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-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