Lamitrode® 3262Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734402132), received between Oct 29, 2018 and Dec 9, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “High impedance” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025High impedance; High impedance

  ADDITIONAL INFORMATION INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23753440 ↗
• InjuryMay 14, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019581 ↗
• InjuryMar 18, 2024High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2024-01725. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS SUCH, SURGICAL INTERVENTION OCCURRED AND THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18926589 ↗
• InjuryMar 18, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 18924379 ↗
• InjurySep 21, 2021High impedance; High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON SEVERAL CONTACTS DURING AN IPG REPLACEMENT (RELATED MANUFACTURER REFERENCE NUMBER 1627487-2021-17150). AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD DURING THE SAME PROCEDURE. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510202 ↗
• InjuryMar 24, 2021High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

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

  MAUDE report 11566608 ↗
• InjuryNov 23, 2020High impedance; Therapeutic or Diagnostic Output Failure; High impedance; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT HAD INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10887335 ↗
• InjuryOct 7, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-32250. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED. DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10644782 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2020-31444. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-31488. IT WAS REPORTED THAT PATIENT HAD INFECTION AT THE SITE OF THE IPG AND LEADS. PATIENT UNDERWENT SURGERY ON (B)(6) 2020 WHEREIN THE LEADS AND IPG WERE EXPLANTED. INFECTION HAS SINCE RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 10537823 ↗
• InjurySep 4, 2020Impedance Problem; Therapeutic or Diagnostic Output Failure; Impedance Problem; Therapeutic or Diagnostic Output Failure

  MANUFACTURER REPORT NUMBER 1627487-2020-01743. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO INVALID IMPEDANCE ISSUE. THE DEVICE SYSTEM WAS EXPLANTED, AND A NEW DEVICE SYSTEM WAS IMPLANTED. THERAPY WAS RESTORED POST PROCEDURE. PATIENT WAS STABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10492340 ↗
• InjuryJul 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE 3 OF 3. REFERENCE MFR. REPORT #: 1627487-2020-22678, REFERENCE MFR. REPORT #: 1627487-2020-22679. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10267875 ↗
• InjuryMar 29, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-03231. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-03232. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. ATTEMPTS TO REPROGRAM THE SYSTEM WERE UNSUCCESSFUL. AS A RESULT, PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2020, WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9896217 ↗
• InjuryMar 29, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-03229. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-03232. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. ATTEMPTS TO REPROGRAM THE SYSTEM WERE UNSUCCESSFUL. AS A RESULT, PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2020, WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9896216 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-13529 , 1627487-2019-13530 , 1627487-2019-13532 , 1627487-2019-13535. IT WAS REPORTED THE PATIENT MAY UNDERGO SURGICAL INTERVENTION FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION IS PENDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9413234 ↗
• InjuryAug 9, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2019-03010. IT WAS REPORTED THE PATIENT EXPERIENCED VIBRATION. AS A RESULT THE PATIENT UNDERWENT SURGICAL INTERVENTION (DATE UNKNOWN).

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 8878826 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURER REFERENCE REPORT: 3006705815-2019-02278. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY. REPROGRAMMING WAS ATTEMPTED WITHOUT SUCCESS. AS A RESULT, THE SYSTEM WAS EXPLANTED ON (B)(6) 2016.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8723055 ↗
• InjuryMay 29, 2019High impedance; Low impedance; High impedance; Low impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06229, 1627487-2019-06231, 3006705815-2019-02296. FOLLOW UP INFORMATION RECEIVED THAT THE PATIENT UNDERWENT SURGERY IN WHICH TWO LEADS AND THE IPG WERE REPLACED. PATIENT HAS EFFECTIVE THERAPY POST OPERATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8651335 ↗
• InjuryMay 29, 2019High impedance; Low impedance; High impedance; Low impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06230, 1627487-2019-06231, 3006705815-2019-02296. FOLLOW UP INFORMATION RECEIVED THAT THE PATIENT UNDERWENT SURGERY IN WHICH TWO LEADS AND THE IPG WERE REPLACED. PATIENT HAS EFFECTIVE THERAPY POST OPERATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8651334 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 3 OF 4. REFERENCE MFR. REPORT NUMBER: 1627487-2019-02798. REFERENCE MFR. REPORT NUMBER: 1627487-2019-02799. REFERENCE MFR. REPORT NUMBER: 1627487-2019-02801. IT WAS REPORTED THAT PATIENT EXPERIENCED LOSS OF THERAPY AFTER PATIENT WAS INVOLVED IN AN AUTOMOBILE ACCIDENT. AS A RESULT, PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2019 WHERE THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8396322 ↗
• InjuryOct 29, 2018High impedance; High impedance

  IT WAS REPORTED THE PATIENT LOST THERAPY. LEAD DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE LEAD CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. REPORTEDLY, THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8013941 ↗

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-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-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-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-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-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-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-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