Lamitrode™ 3288Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05414734406307), received between Sep 18, 2018 and Apr 13, 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.

• InjuryApr 13, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24866014 ↗
• InjuryJan 22, 2026High impedance

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24144285 ↗
• InjuryNov 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE ON THE LEAD. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23597824 ↗
• InjuryMar 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT IMPEDANCE CHECK REVEALED HIGH IMPEDANCE ON THE LEAD. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE. PATIENT HAS EFFECTIVE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548473 ↗
• InjuryDec 11, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT HAS INEFFECTIVE STIMULATION DUE TO LOW IMPEDANCES ON THEIR LEAD. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 20909077 ↗
• InjuryMay 21, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THEIR SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS ELECTIVELY REPLACED, AND THE LEAD WAS DISCONNECTED FROM THE IPG AND LEFT IMPLANTED WHILE ALSO IMPLANTING A NEW SCS SYSTEM TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST-OP

  Patient problems: Inadequate Pain Relief

  MAUDE report 19365243 ↗
• InjuryJun 26, 2023Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-03874. IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO THE LEAD MIGRATING. ADDITIONALLY, THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17203868 ↗
• InjuryMay 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT LEADS WERE EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME. IT IS UNKNOWN WHICH LEAD IS LIABLE.

  Patient problems: Insufficient Information

  MAUDE report 16950212 ↗
• InjuryMay 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2023 ADDRESSING AN IPG REPLACEMENT DUE TO NORMAL END OF LIFE, THE PATIENT'S LEAD WAS FOUND TO BE FRACTURED. AS A RESULT, THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED WITH A NEW ONE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16843567 ↗
• InjuryMar 24, 2023Impedance Problem; Impedance Problem

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION OCCURRED WHERE THE LEAD WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16612961 ↗
• InjuryFeb 9, 2023High impedance; High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16337356 ↗
• InjuryJan 24, 2023Fracture; Fracture

  RELATED MANUFACTURER REPORT:1627487-2023-00302. PATIENTS IPG WAS REPORTEDLY INOPERABLE. IT WAS ALSO DISCOVERED THAT THE PATIENTS ONLY LEAD WAS FRACTURED. PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2023. THE PATIENTS THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16237617 ↗
• InjuryDec 28, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT'S LEAD WAS NOT PLACED PROPERLY TO PROVIDE ADEQUATE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN IN WHICH THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16061810 ↗
• InjuryOct 29, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2022-17729. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AND THE IPG WAS DEEMED INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022, WHEREIN A NEW DRG SYSTEM WAS IMPLANTED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY, HOWEVER THE SCS SYSTEM REMAINS IMPLANTED. ADDITIONAL SURGERY MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15697262 ↗
• InjurySep 30, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAS INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY OCCUR.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15514743 ↗
• InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-04602. IT WAS REPORTED THAT DURING A ROUTINE BATTERY REPLACEMENT PROCEDURE, HEAVY INFECTION WAS OBSERVED AT THE IPG AND LEAD SITE. AS A RESULT, THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 15307953 ↗
• InjuryMay 5, 2022Intermittent Shock/Stimulation; Intermittent Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02554. IT WAS REPORTED THAT PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION AND HAS NOT CHARGED OR USED THE THORACIC SCS SYSTEM IN MORE THAN TWO YEARS. THE IPG WAS DEEMED INOPERABLE AND PATIENT LOST THERAPY. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 14291536 ↗
• InjuryAug 25, 2021High impedance; High impedance

  IT WAS REPORTED THE PATIENTS LEAD DISPLAYED HIGH IMPEDANCE ON ALL CONTACTS RESULTING IN INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12364486 ↗
• InjuryMay 14, 2021High impedance; High impedance

  RELATED MANUFACTURE NUMBER: 3006705815-2021-02844. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829404 ↗
• InjuryApr 17, 2021High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ORIGINAL DEVICE INFORMATION REPORTED WAS INCORRECT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11683149 ↗
• InjuryDec 4, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER 3006705815-2020-32988. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10945367 ↗
• InjuryOct 26, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  DEVICE 1 OF 2 REFERENCE MFR. REPORT #: 3006705815-2020-32260. IT WAS REPORTED THE PATIENT HAD BEEN RECEIVING INADEQUATE COVERAGE. AS A RESULT, AN ADDITIONAL SCS SYSTEM WAS IMPLANTED ON (B)(6) 2020 TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10738093 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-23934. IT WAS REPORTED THE PATIENT EXPERIENCED DRAINAGE AT AN UNKNOWN SITE. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Fluid Discharge

  MAUDE report 10405894 ↗
• InjuryApr 9, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. FURTHER INFORMATION REVEALED THE PATIENT LOST A SIGNIFICANT AMOUNT OF WEIGHT. THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT¿S LEAD WHICH WAS SUCCESSFUL.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9945759 ↗
• InjuryMar 18, 2020Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THE PATIENT BEGAN TO RECEIVE INEFFECTIVE THERAPY FOLLOWING A MOTOR VEHICLE ACCIDENT. AN IMPEDANCE CHECK WAS PERFORMED AND REVEALED HIGH IMPEDANCE. IMAGING RESULTS REVEALED THE PATIENT'S LEAD HAD MIGRATED. REPROGRAMMING WAS PERFORMED BUT WAS ONLY HELPFUL FOR A LIMITED TIME. AS A RESULT, THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9849899 ↗

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-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-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-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-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