Lamitrode Tripole™ 3214 (UDI 05415067017789)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05415067017789), received between May 4, 2021 and Dec 15, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “High impedance” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Impedance Problem; Impedance Problem

  ADDITIONAL INFORMATION INDICATES THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813078 ↗
• InjuryAug 21, 2025High impedance; High impedance

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

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22857542 ↗
• InjuryNov 9, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PATIENT'S IPG REPLACEMENT ON (B)(6) 2023 THE PATIENT'S LEAD WAS DAMAGED, AND ONE CONTACT WAS REMOVED. THERAPY WAS RESTORED USING THE REMAINING CONTACTS ON THE LEAD.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18106675 ↗
• InjurySep 8, 2023High impedance; High impedance

  MANUFACTURER REFERENCE NUMBER:1627487-2023-03617. IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE TO REPLACE THE IPG ON 21 AUG 2023. DURING THE IPG REPLACEMENT PROCEDURE, HIGH IMPEDANCE ON THE LEAD WAS OBSERVED. AS A RESULT, THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711279 ↗
• InjuryJun 12, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES ON THEIR LEAD. IT IS NOT KNOWN WHICH LEAD CONTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION OCCURRED ON (B)(6) 2023 DURING WHICH THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17110519 ↗
• InjuryMay 19, 2023Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD IS EXHIBITING HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16963539 ↗
• InjuryJan 10, 2023Failure to Deliver Energy; Failure to Deliver Energy

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-00150. IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES AND THE LEAD WAS UNDERGOING INVALID IMPEDANCES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND BOTH THE IPG AND LEAD WERE DEEMED INOPERABLE. SURGICAL INTERVENTION WAS TAKEN ON (B)(6) 2022.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16132939 ↗
• InjuryOct 26, 2022High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-05869. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION IS PENDING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15677644 ↗
• InjuryMay 4, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  MANUFACTURER REFERENCE NUMBER:1627487-2021-13658. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11767779 ↗

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-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-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-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-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-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