Eon™ 3716Recalls & reported problems

Advanced Neuromodulation Systems, Inc. · Rechargeable IPG, 16-Channel · Class 3 · Implant

Quick summary

This Advanced Neuromodulation Systems Eon spinal cord stimulator appears in 674 adverse event reports, with no deaths and 669 injuries. Reports mostly describe patients getting too little pain relief and the implanted unit losing its ability to communicate with external controllers, some of which led to surgery to replace it. Reports fell over the last 12 months, to 9 from 19 in the 12 months before, and there are no recalls that name 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: 669
Deaths reported: 0
Injuries reported: 664
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 669 adverse event reports that list this exact device (DI 05414734402583), received between Jun 26, 2018 and Apr 22, 2026 — classified as 664 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (178 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Improper or Incorrect Procedure or Method178
Wireless Communication Problem175
Adverse Event Without Identified Device or Use Problem95
Insufficient Device Problem Information59
Therapeutic or Diagnostic Output Failure57
Use of Device Problem47
No Device Output31
Premature Discharge of Battery24

Patient problems

Inadequate Pain Relief502
No Consequences Or Impact To Patient41
Insufficient Information23
Pain19
Discomfort18
No Clinical Signs, Symptoms or Conditions18
Failure of Implant16
Implant Pain13

Recent adverse event reports

The 25 most recent of 669 reports, in the reporter's own words as published by the FDA.

InjuryApr 22, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR IPG EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24957442 ↗
InjuryMar 16, 2026Improper or Incorrect Procedure or Method
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 WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24604512 ↗
InjuryFeb 10, 2026Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN IN THE FUTURE.
Patient problems: Inadequate Pain Relief
MAUDE report 24310473 ↗
InjuryDec 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR IPG EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23760530 ↗
InjurySep 11, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
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 MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23023198 ↗
InjurySep 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED PATIENT'S IPGS BECAME INOPERABLE DUE TO PATIENT STOPPED CHARGING. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUES.
Patient problems: Inadequate Pain Relief
MAUDE report 22935501 ↗
InjuryAug 25, 2025No Apparent Adverse Event; Wireless Communication Problem; No Apparent Adverse Event; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT¿S ENTIRE SYSTEM WAS EXPLANTED ON AN (B)(6) 2025 FOR AN UNKNOWN REASON.
Patient problems: Failure of Implant; Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 22891468 ↗
InjuryAug 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT¿S ENTIRE SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 22879458 ↗
InjuryAug 20, 2025Battery Problem; No Apparent Adverse Event; Battery Problem; No Apparent Adverse Event
ADDITIONAL INFORMATION INDICATED THE IPGS MET OR EXCEEDED 75% EXPECTED LONGEVITY. THERE IS NO DEVICE MALFUNCTION.
Patient problems: Failure of Implant; Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 22851349 ↗
InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED PATIENT'S IPG WAS EXPLANTED AT AN UNKNOWN TIME DUE TO AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 22820321 ↗
InjuryAug 15, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
IT WAS REPORTED THAT SURGICAL INTERVENTION TO EXPLANT THE SYSTEM MAY BE UNDERTAKEN FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22819260 ↗
InjuryJul 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
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 WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22544218 ↗
InjuryMay 21, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT PATIENTS IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON 02 MAY 2025 WHEREIN IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 22065043 ↗
InjuryMay 12, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO THE LEAD BEING IMPLANTED AT A SUBOPTIMAL LEVEL. ADDITIONALLY, THE PATIENT IPG WAS INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE DEVICES WERE EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 22003590 ↗
InjuryApr 1, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED PATIENT SCS 3716 IPG WAS NOT PROVIDING EFFECTIVE THERAPY. IPG WAS EXPLANTED AND REPLACED WITH COMPETITOR'S IPG AT AN UNKNOWN DATE. BSX IPG OFFERED FEATURES NOT AVAILABLE IN 3716 DEVICES.
Patient problems: Inadequate Pain Relief
MAUDE report 21748542 ↗
InjuryMar 11, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
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 WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21576010 ↗
InjuryFeb 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT IPG WAS EXPLANTED AT AN UNKNOWN TIME AND UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 21376708 ↗
InjuryFeb 9, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S SCS SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON. THE DATE OF EXPLANT IS UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21340923 ↗
InjuryJan 22, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
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 MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21211318 ↗
InjuryJan 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED PATIENTS¿ SYSTEM WAS EXPLANTED FOR UNKNOWN REASON AT AN UNKNOWN TIME.
Patient problems: Insufficient Information
MAUDE report 21120833 ↗
InjuryDec 30, 2024Improper 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. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN IPG AS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21043872 ↗
InjuryDec 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED SCS IPG WAS EXPLANTED AT AN UNKNOWN TIME AND UNKNOWN REASON. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20886996 ↗
InjuryDec 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT NO LONGER HAD THEIR 3716 IPG AND WAS EXPLANTED A WHILE AGO. THAT IPG WAS REPLACED WITH A 3660 IPG. THE REASON FOR EXPLANT IS UNKNOWN AT THIS TIME
Patient problems: Insufficient Information
MAUDE report 20871160 ↗
InjurySep 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD IPG EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 20181825 ↗
InjuryJul 26, 2024Extracardiac stimulation; Extracardiac stimulation
IT WAS REPORTED THAT PATIENT WAS EXPERIENCING SHOCKING AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. SHOCKING AT THE IPG SITE HAS RESOLVED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 19838191 ↗

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-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-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-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-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-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-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-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

Device details

UDI-DI	`05414734402583`
Brand	Eon™
Model	3716
Company	Advanced Neuromodulation Systems, Inc.
Product code	LGW · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Class	Class 3
FDA submission	P010032
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Aug 15, 2023

Device type (GMDN): Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.

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All STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.