Lamitrode® 3240Recalls & reported problems
Advanced Neuromodulation Systems, Inc. · 4 Lead Kit, 60cm Length · Class 3 · Implant
Quick summary
This Lamitrode 3240 is a four-lead kit used with an implanted spinal cord stimulator for pain relief. The 45 reports mostly describe leads that stopped working well enough to relieve pain, sometimes because the lead fractured or disconnected, and several patients needed surgery to remove or replace them; a few mention leads eroding through the scalp. All 45 reports describe injuries, with no deaths. There are no recalls for this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 05414734402033), received between Sep 11, 2018 and Sep 30, 2026 — classified as 46 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.
Reports received per month
Most reported problems
Device problems
- High impedance12
- Therapeutic or Diagnostic Output Failure12
- Adverse Event Without Identified Device or Use Problem10
- Fracture5
- Impedance Problem3
- Disconnection2
- Material Twisted/Bent2
- Migration2
Patient problems
- Inadequate Pain Relief35
- Erosion3
- Hematoma2
- Unspecified Infection2
- Insufficient Information1
- No Consequences Or Impact To Patient1
- Rash1
- Skin Erosion1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
Patient problems: Inadequate Pain Relief
MAUDE report 50947826 ↗InjuryAug 18, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES ON THEIR OCCIPITAL LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 22836140 ↗InjuryApr 30, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21937837 ↗InjuryApr 30, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21937804 ↗InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE OCCIPITAL LEADS WERE ERODING THROUGH THE SCALP. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE OCCIPITAL LEADS WERE EXPLANTED TO ADDRESS THIS ISSUE.
Patient problems: Erosion
MAUDE report 20349050 ↗InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE OCCIPITAL LEADS WERE ERODING THROUGH THE SCALP. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE OCCIPITAL LEADS WERE EXPLANTED TO ADDRESS THIS ISSUE.
Patient problems: Erosion
MAUDE report 20348833 ↗InjuryJan 9, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00199, 1627487-2024-00200, 1627487-2024-00202 IT WAS REPORTED PATIENT'S SCS SYSTEM DID NOT PROVIDE EFFECTIVE THERAPY AND WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Inadequate Pain Relief
MAUDE report 18480105 ↗InjuryJan 9, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00199, 1627487-2024-00200, 1627487-2024-00201. IT WAS REPORTED PATIENT'S SCS SYSTEM DID NOT PROVIDE EFFECTIVE THERAPY AND WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Inadequate Pain Relief
MAUDE report 18480101 ↗InjuryDec 22, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT HAD A NEW SYSTEM IMPLANTED ON (B)(6) 2023 FOR THE SAME PAIN PATTERN. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD ON THE OTHER SYSTEM RESULTED IN INEFFECTIVE STIMULATION.
Patient problems: Inadequate Pain Relief
MAUDE report 18384790 ↗InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO ONE LEAD ERODING. DATE OF EXPLANT IS UNKNOWN.
Patient problems: Erosion
MAUDE report 17367387 ↗InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 WHEREIN A NEW LEAD WAS IMPLANTED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
Patient problems: Skin Erosion
MAUDE report 16244321 ↗InjuryDec 7, 2022High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE ON ONE OF THE OCCIPITAL LEADS. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.
Patient problems: Inadequate Pain Relief
MAUDE report 15933752 ↗InjuryNov 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REMOVE THE IMPLANTED SYSTEM ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 15813064 ↗InjuryOct 24, 2022Fracture; Fracture
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-05799. IT WAS REPORTED THAT THE PATIENT'S LEADS HAD HIGH IMPEDANCES DUE TO LEAD FRACTURE. AS A RESULT, THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 15664200 ↗InjuryOct 24, 2022Fracture; Fracture
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-05797. IT WAS REPORTED THAT THE PATIENT'S LEADS HAD HIGH IMPEDANCES DUE TO LEAD FRACTURE. AS A RESULT, THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 15664177 ↗InjuryMay 6, 2022High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S LEAD WAS FOUND TO HAVE HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 14310489 ↗InjuryMay 4, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER:1627487-2022-02538. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL INTERVENTION ON (B)(6) 2022 WHEREIN 2 NEW LEADS WERE ADDED TO GET BETTER COVERAGE OF THE PATIENT¿S FOOT PAIN. REPORTEDLY, PATIENT HAS ADEQUATE COVERAGE POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 14274604 ↗InjuryMay 4, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER:1627487-2022-02539. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL INTERVENTION ON (B)(6) 2022 WHEREIN 2 NEW LEADS WERE ADDED TO GET BETTER COVERAGE OF THE PATIENT¿S FOOT PAIN. REPORTEDLY, PATIENT HAS ADEQUATE COVERAGE POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 14274426 ↗InjuryMar 1, 2022Material Twisted/Bent; Material Twisted/Bent
RELATED MANUFACTURER REPORT NUMBER 1627487-2022-01151. IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES FOUND ON THE LEADS. ON FURTHER INVESTIGATION, IT WAS SEEN THAT THE LEADS WERE TWISTED AROUND THE IPG, CAUSING THE LEADS TO BREAK. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 13637795 ↗InjuryMar 1, 2022Material Twisted/Bent; Material Twisted/Bent
RELATED MANUFACTURER REPORT NUMBER 1627487-2022-01150. IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES FOUND ON THE LEADS. ON FURTHER INVESTIGATION, IT WAS SEEN THAT THE LEADS WERE TWISTED AROUND THE IPG, CAUSING THE LEADS TO BREAK. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 13637670 ↗InjuryJan 7, 2022High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00073. IT WAS REPORTED THAT DURING DEVICE ASSESSMENT, ONE OF THE LEAD DISPLAYED HIGH IMPEDANCE ON THE LEFT OCCIPITAL. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS LEFT SO BOTH LEADS ARE REPORTED.
Patient problems: Inadequate Pain Relief
MAUDE report 13193698 ↗InjuryJan 7, 2022High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00074. IT WAS REPORTED THAT DURING DEVICE ASSESSMENT, ONE OF THE LEAD DISPLAYED HIGH IMPEDANCE ON THE LEFT OCCIPITAL. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS LEFT SO BOTH LEADS ARE REPORTED.
Patient problems: Inadequate Pain Relief
MAUDE report 13193686 ↗InjuryJul 27, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-03619. IT WAS REPORTED THAT THE PATIENT EXPERIENCED TINGLING SENSATION AT THE IPG SITE AND LEAD SITE. AS A RESULT, SURGERY OCCURRED TO EXPLANT AND REPLACE THE SYSTEM TO ADDRESS THE ISSUE.
Patient problems: Undesired Nerve Stimulation
MAUDE report 12230241 ↗InjuryMay 24, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2021-14352. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE ADEQUATE THERAPY FROM THEIR SYSTEM. THE PATIENT ALSO EXPERIENCED SPASMS AND UNCOMFORTABLE STIMULATION. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED, RESOLVING THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 11872116 ↗InjuryMay 24, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2021-14353. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE ADEQUATE THERAPY FROM THEIR SYSTEM. THE PATIENT ALSO EXPERIENCED SPASMS AND UNCOMFORTABLE STIMULATION. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED, RESOLVING THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 11872111 ↗
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, ClassifiedEterna SCS IPG (Implantable Pulse Generator), Model Number 32400
- Z-2510-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 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-2511-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 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, ClassifiedProclaim 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-2508-2023 · Jul 18, 2023 · Open, ClassifiedProclaim 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-2506-2023 · Jul 18, 2023 · Open, ClassifiedProclaim" 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, ClassifiedProclaim 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, ClassifiedProclaim 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-2691-2017 · Jun 2, 2017 · TerminatedProclaim 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 · TerminatedProclaim 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 · TerminatedEon 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 · TerminatedThe 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 · TerminatedEon - 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 · TerminatedSoftware 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
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- Precision Spectra ™ SC-1132Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF53 deaths11,269 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.