Eterna™ 32400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,547 adverse event reports that list this exact device (DI 05415067040763), received between Apr 4, 2023 and Sep 30, 2026 — classified as 5 deaths, 1,532 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (289 reports).

1 FDA recall record name this device's identifier, 1 still open.

13 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.

Recalls naming this device

1. Oct 6, 2025Open, Classified

   There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

   Z-0458-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,547 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50952816 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Implant Pain

  MAUDE report 50952559 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50951761 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Wound Dehiscence

  MAUDE report 50950019 ↗
• InjurySep 30, 2026Wireless Communication Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50948557 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 50947738 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's IPG site opened and the system was protruding. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted to address the issue.

  Patient problems: Erosion

  MAUDE report 50937949 ↗
• InjurySep 29, 2026Wireless Communication Problem

  It was reported that the patient is unable to charge their IPG. As a result, surgical intervention may be undertaken in the future.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50936627 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient experienced pain at the IPG site. Surgical intervention was undertaken wherein the IPG was relocated and replaced to resolve the issue.

  Patient problems: Implant Pain

  MAUDE report 50936237 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported the patient experienced shocking. As a result, the IPG was explanted to address the issue.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 50932250 ↗
• InjurySep 28, 2026Migration

  It was reported the IPG was moving in the pocket site causing discomfort. Surgical intervention took place wherein the IPG was explanted, replaced and relocated to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50917554 ↗
• OtherSep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was repositioned to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50917003 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50902460 ↗
• InjurySep 25, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900381 ↗
• InjurySep 25, 2026Migration

  It was reported that following recent weight loss, the patient experienced migration of the IPG. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899896 ↗
• InjurySep 24, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892226 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50892175 ↗
• InjurySep 24, 2026High impedance

  It was reported that the patient experienced ineffective therapy. Diagnostics revealed both leads were fully impeded. Reprogramming has been unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50888960 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain at the IPG implant site. Surgical intervention was undertaken on (b)(6) 2026, where the IPG was repositioned to a different location. Therapy was restored post operatively.

  Patient problems: Implant Pain

  MAUDE report 50888942 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain at the IPG site. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50884381 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient experienced an infection and the IPG site as well as unable to enter MRI mode due to impedances. Infection was treated with oral antibiotics. Surgical intervention took place wherein the IPG was explanted, replaced and relocated. The lead was also explanted and replaced to address the issue.

  Patient problems: Unspecified Infection

  MAUDE report 50883302 ↗
• InjurySep 22, 2026Wireless Communication Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50860761 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's IPG site incision opened. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was replaced to address the issue. Therapy was restored post-operatively.

  Patient problems: Wound Dehiscence

  MAUDE report 50860336 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was replaced to address the issue. Therapy was restored post-operatively.

  Patient problems: Implant Pain

  MAUDE report 50860216 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection. As a result, the SCS system was removed. Date of removal is not known.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50857892 ↗

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-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-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-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-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