Eon™ 3851Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 05414734402736), received between Aug 24, 2018 and Sep 10, 2025 — classified as 99 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (34 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 101 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE EXTENSION SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 23023092 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE EXTENSION SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 23023091 ↗
• InjuryJul 28, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22639628 ↗
• InjuryFeb 1, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT PATIENTS IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18622262 ↗
• InjuryJan 22, 2024Wireless Communication Problem; Wireless Communication Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18556366 ↗
• InjuryOct 25, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT STOPPED CHARGING THEIR RECHARGEABLE IPG BECAUSE THEY DID NOT HAVE ADEQUATE THERAPY. AS SUCH, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18006951 ↗
• InjuryJun 23, 2023Wireless Communication Problem; Wireless Communication Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE WHERE THE PATIENTS IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17194860 ↗
• InjuryJan 18, 2023Wireless Communication Problem; Wireless Communication Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGICAL INTERVENTION TOOK PLACE WHERE THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16195906 ↗
• InjuryDec 7, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO IPG BEING INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 15932834 ↗
• InjuryDec 4, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT STOPPED CHARGING THE IPG, RENDERING THE IPG INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG ADDRESSING THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15912548 ↗
• InjuryNov 23, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. IN TURN, THE IPG BECAME INOPERABLE, AND PATIENT LOST THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15858369 ↗
• InjuryNov 9, 2022Wireless Communication Problem; Wireless Communication Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-06133. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY AND THEIR IPG WAS INOPERABLE. IT IS UNKNOWN WHEN THE PATIENT LOST THERAPY. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15764463 ↗
• InjuryOct 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION AT AN UNKNOWN DATE, WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 15583032 ↗
• InjuryAug 26, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AT AN UNKNOWN DATE. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15306948 ↗
• InjuryAug 19, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT STOPPED USING AND CHARGING THE DEVICE DUE TO PAIN AT THE IPG SITE. AS SUCH, THE IPG BECAME INOPERABLE. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG ADDRESSING THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP.

  Patient problems: Implant Pain; Inadequate Pain Relief

  MAUDE report 15256468 ↗
• InjuryJul 29, 2022Improper or Incorrect Procedure or Method; Wireless Communication Problem; Improper or Incorrect Procedure or Method; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO IPG BEING INOPERABLE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15130583 ↗
• InjuryJul 7, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG ADDRESSING THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14950363 ↗
• InjuryJun 28, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO IPG BEING INOPERABLE. REPORTEDLY, THERE WAS CHARGING PROBLEMS AND THE IPG STOPPED WORKING IN 2015. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 14846399 ↗
• InjuryApr 13, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE STIMULATION. DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14102424 ↗
• InjuryMar 17, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT LOST THERAPY DUE TO NOT CHARGING THE IPG. THE PATIENT HAS NOT RECHARGED OR USED THE IPG IN YEARS. THE ISSUE WAS RESOLVED THROUGH AN IPG REPLACEMENT. EFFECTIVE THERAPY RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13797441 ↗
• InjuryFeb 23, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE DUE TO USER ERROR. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT'S IPG, RESOLVING THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13586702 ↗
• InjuryFeb 23, 2022Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEATING AT THE IPG SITE. SURGICAL INTERVENTION IS ANTICIPATED.

  Patient problems: Burning Sensation

  MAUDE report 13586646 ↗
• InjuryNov 23, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT HAD HIS SCS IPG REPLACED ON (B)(6) 2021 BECAUSE THE IPG WAS INOPERABLE. STIMULATION THERAPY WAS REPORTEDLY RESTORED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12863821 ↗
• InjuryNov 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED INDICATED SURGICAL INTERVENTION OCCURRED WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12862485 ↗
• InjuryOct 18, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT'S IPG. SURGICAL INTERVENTION RESOLVED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12648297 ↗

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-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-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-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